Tag Archives: Clean Rooms

By Carrie Meadows

As a first-time attendee at an Institute for Environmental Science and Technology (IEST) Working Group session, one probably doesn’t expect an animated crowd of participants sticking neon Post-It® notes on the walls. But at the inaugural meeting of proposed RP-CC044.1, “Vacuum Cleaning Systems for Cleanrooms,” at ESTECH in May, that is exactly what took place.

Roger Diener, chair of the new Working Group and contamination control engineer at Analog Devices (Wilmington, MA), took an unusual approach to the brainstorming session, one that has actually been in existence since the 1960s. Instead of soliciting feedback via the typical orderly roundtable discussion, Diener handed out the aforementioned brightly colored notepads to participants, instructing them to jot down any user-related aspect of cleanroom vacuum cleaners and stick them to any number of poster-sized papers on the walls, which were labeled with broad headings such as “general background,” “features,” “performance expectations,” “portable unit design considerations,” “design criteria,” and more. This technique, part of the K-J Method (or affinity diagram) invented by a Japanese anthropologist as a way to discover meaningful groups of ideas in a raw list, enabled the dynamic that produced an entire set of core expectations for the group’s attendees to fill in at a later date.

“I did it because a lot of people do have a different idea of what a Working Group meeting is,” says Diener. He notes that some attendees are reluctant to participate in a conventional setting, especially when they are new to the industry or RP process. The Working Group is composed of IEST members who design, manufacture, and use the systems for various cleanroom applications. “There are many different levels of experience to be incorporated into a well-rounded group. Some participants can be intimidated by that. This way gets all the questions and ideas out there, from basic to advanced, without putting anyone on the spot.”

Diener says that vacuum cleaning systems had been on the “short list” of topics that needed someone to rally for it in order to get the RP process rolling. Once it was identified as a need and he volunteered to chair the group, it was time to contact the manufacturing experts and get users to participate. During the Working Group session, Diener had pointed out that “a cleanroom is not just a ‘clean room’–it’s the largest piece of equipment [in your facility], and people need to act accordingly.” The Working Group is tasked with moving the proposed RP forward, keeping in mind the purpose of the vacuum cleaning system itself: to aid in the removal of large particles, fibers, and debris without becoming a risk to the surrounding environment.


IEST members brainstorm an initial draft of the proposed RP-CC044.1, “Vacuum Cleaning Systems for Cleanrooms.” Photo courtesy of IEST.
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“This document is intended to address the needs and issues you should understand when buying, specifying, and using a cleanroom vacuum cleaner,” he explains. “Let’s be clear: We’re not telling users, ‘This is how you should clean your cleanroom environment.’ With this RP, we’re recommending, ‘This is what you need to know about the [vacuum] equipment you’re bringing into the environment to keep contamination from becoming a problem.’”

The importance of these proposed guidelines lies in clearly outlining what is appropriate for a cleanroom vacuum cleaning system, agrees Ray McCarthy, a sales representative for industrial vacuum manufacturer Nilfisk CFM (Kingstown, RI) and a member of the Working Group. “I think it is important to note here that a vacuum is part of the whole cleaning process within a cleanroom environment. Each cleanroom is unique to whatever is being done within that cleanroom, whether it is a tableting process for the pharmaceutical industry or a fab within a semiconductor facility

SEMICON West 2008


July 1, 2008

JULY 14–18, 2008
MOSCONE CENTER, SAN FRANCISCO, CA

Event hours

Exhibits
Tuesday, July 15–Wednesday, July 16  10:00 a.m.–6:00 p.m.
Thursday, July 17  10:00 a.m.–4:00 p.m.

Conference program runs from Monday, July 14, through Friday, July 18

SEMI, the global industry association serving the semiconductor manufacturing supply chain, is hosting its 38th annual SEMICON West Conference and Exhibition from July 14–18. Attendees will have the chance to learn about the latest developments in nano and microelectronics, packaging/assembly, wafer processing, and more, including special topics such as sustainability and repurposing fabs. For a complete conference schedule, visit www.semi.org.

show highlights

Keynote: “Semiconductor Technology, A Convergence of Technology and Business Models”
Tuesday, July 15, 1:30–2:15 p.m.

Bernie Meyerson, vice president for strategic alliances and CTO, IBM Fellow, IBM Systems and Technology Group, will explore the relationship between silicon technology (scaling, in cost and performance) and the semiconductor business model. This talk will cover the extraordinary measures required to sustain both trajectories and the progress being made.

200mm Productivity Symposium: How to Breathe Life into Old Fabs

Tuesday, July 15, 12:30–5:30 p.m.

Fab repurposing is going on across the globe and spurring additional business and growth opportunities equipment and materials supplies, and their customers. At this SEMICON West Forum, companies up and down the supply chain will show how they are profiting from fab repurposing.

EHS and Sustainability Programs and Events

Energy Conservation in the Semiconductor Industry: Obstacles and Opportunities for Energy Reduction in Equipment and Fabs (Co-Presented by SEMI and ISMI)

Tuesday, July 15, 2:00–5:00 p.m.

Device Scaling TechXPOT Session: Advances in Device Manufacturing: Productivity, Process Control and Sustainability

Wednesday, July 16, 10:30 a.m.–12:30 p.m.

Growing public and corporate interest in sustainability and environmental issues are creating new challenges and opportunities for companies and individuals across the global microelectronics and related industries.

North American Photovoltaic Advanced Manufacturing Technology Conference

Session 1: Thin Film/Equipment
Tuesday, July 15, 2:00–6:00 p.m.

Session 2: Bulk Silicon/PV Manufacturing
Wednesday, July 16, 9:00 a.m.–1:00 p.m.

The Photovoltaic Advanced Manufacturing Technology Conference will focus on the solutions, manufacturing equipment, and technology that the industry is able to provide to wafer, cell, and module makers. Elements of the production process will be highlighted: integrated logistics and automation; quality control and traceability, (advanced) statistical process control, and preventive maintenance.

ITRS Summer Public Conference

Wednesday, July 16, 7:00 a.m.–5:15 p.m.

In addition to the Roadmap working groups’ highlights and key messages of the 2008 Update, the conference will include executive forums for two special topics. The morning breakfast session provides interactive discussions on global energy and how the ITRS can influence outcomes. An afternoon session focuses on the challenges of the industry supply chains.

The 450 mm Transition: When Will It Make Economic Sense for the Semiconductor Industry Ecosystem?

Thursday, July 17, 8:00–9:30 a.m.

Over the past few years, SEMI, through its Equipment Productivity Working Group (EPWG), has been studying the overall cost and benefit of a potential transition to 450-mm wafers. The goal of the study has been to develop transparent, objective analysis tools and data which would help the industry to determine what the potential outcomes a new wafer size transition would bring for the industry and what the right path might be for each individual company. A summary talk on the results of the analysis will be followed by a panel discussion from the team of experts who had a role in developing the model and analysis.

Exhibitor showcase

More than 1,100 leading companies and suppliers connected to the semiconductor manufacturing industry will display their innovations at SEMICON West 2008. Here are a few that will be of interest to the contamination control community.

Asahi/America, Inc.

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Web: www.asahi-america.com
Booth 133

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Asahi/America, Inc. is a manufacturer and distributor of a full line of corrosion-resistant thermoplastic fluid handling products, including valves, actuators, pipe, and fittings. Asahi specializes in providing solutions for fluid handling systems individualized to meet virtually any customer’s need. For more information, contact Asahi/America, Inc., 35 Green St., Malden, MA 02148. Call toll free (877) 24-ASAHI or (781) 321-5409, fax (800) 426-7058, or e-mail [email protected].

Web: www.das-europe.com
Booth 2522

DAS–Dünnschicht Anlagen Systeme GmbH Dresden

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DAS develops, distributes, and services waste gas abatement systems for semiconductor, flat-panel display (FPD), and solar cell manufacturers, customized to process requirements with full customer support. DAS’s state-of-the-art technology, quality, and experience have been incorporated in modern manufacturing facilities in Europe, Asia, and North America. More than 2,000 systems have been installed worldwide thanks to a global network of specialists in China, Hong Kong, Japan, Korea, Malaysia, Singapore, Taiwan, and the United States. The company’s ESCAPE technology is featured in a burn/wet system for point-of-use (POU) abatement of all semiconductor manufacturing waste gases, which are environmentally harmful, toxic, and contaminated. The unit combines incineration, scrubbing, and monitoring in one system. AQUABATE technology is provided via a compact wet scrubber designed to scrub waste gases with water or reactive chemicals. The GIANT, UPTIMUM, and EDC systems provide waste gas abatement for FPD and solar cell manufacturing processes: incineration, scrubbing, and electrostatic dust collection.

Entegris, Inc.

Web: www.entegris.com
Booth 1021

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As a materials science and contamination control expert, Entegris enables its customers to improve productivity, reduce cost, and enhance yield. At SEMICON West, Entegris will demonstrate new innovations in wafer handling, liquid and gas filtration, fluid handling, post-CMP cleaning, and specialty coatings applications. Featured products include Torrento™ 15-nm wet etch and clean liquid filters, Impact® 5-nm photoresist filters, IntelliGen® HV high-viscosity photoresist dispense system, LiquidLens® high-flow ultrapure water purification system for immersion lithography applications, Integra® high-temperature valves, Clarilite Certified reticle haze prevention systems, and 300-mm Prime and 450-mm wafer carrier and shipper products.

Lighthouse Worldwide Solutions

Web: www.golighthouse.com
Booth 6158

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Lighthouse Worldwide Solutions will introduce its newest liquid particle counter, the NanoCount 50, at this year’s SEMICON West tradeshow. The NanoCount 50 is an ultrasmall-footprint liquid particle counter with a sensitivity of 50 nm. The unit measures just 9x 6x 9 inches and includes the sensor, counting electronics, and flow meter all housed in a NEMA rated enclosure. The small footprint permits the instrument to be easily integrated into process equipment for POU semiconductor process applications. Lighthouse Worldwide Solutions has also introduced new products for gas particle monitoring and air particle monitoring applications. The new HPC 1100 high-pressure controller enables sampling of high-pressure gas lines at 1 cfm without wasting extra gas. The 1CFM MiniManifold permits sampling of multiple locations with a single particle counter, offering a tool for cost-effectively partitioning particle problems and monitoring minienvironments.

Mettler-Toledo Thornton

Web: www.mt.com
Booth 421

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The 5000TOC sensor and 770MAX multiparameter analyzer provide fast, continuous measurement of total organic carbon (TOC), enabling online process surveillance in an economical analytical package. TOC can be monitored at critical, pure/ultrapure water treatment stages providing low detection limits in less than 60 seconds, which enables real-time correction of process excursions. The 770MAX transmitter provides the flexibility of interfacing up to two 5000TOC sensors, leaving additional channels available for measuring conductivity, pH, dissolved oxygen, ozone, or flow. Mettler-Toledo Thornton specializes in pure and ultrapure water systems with measurements of resistivity/conductivity, dissolved oxygen, ozone, flow, pressure, pH, ORP, temperature, and TOC.

Setra Systems, Inc.

Web: www.setra.com
Booth 541

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Setra Systems, Inc., a manufacturer of variable capacitance vacuum and pressure transducers, will showcase its Model 730 capacitance diaphragm gauge (CDG) at SEMICON West 2008. Designed for semiconductor applications, absorption chillers, lasers, autoclaves, vacuum packaging, freeze drying, and vacuum distillation applications, the low-cost, compact (1.5×2.1-inch) CDG’s high-frequency bridge circuit design is fully RoHS compliant and yields extremely low noise, while maintaining the fast response time required for today’s critical control applications. The Model 730 provides a 0-to-5 VDC or 0-to-10 VDC output that is linear with pressure and independent of gas composition. A wide dynamic measuring range is ensured through percent of reading accuracy (

In the wafer fab, no matter how hard you fight, there are some battles you’ll never win. The best you can do is stave off your enemy–molecular contamination–for as long as possible.

By Sarah Fister Gale

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Since the beginning of wafer manufacturing, cleanroom operators have waged war on contaminants, relying on a growing collection of filters, monitors, and enclosed environments to prevent particles from crushing their yields. But for every step forward they take in contamination control, the industry takes two steps back as shrinking geometries make delicate materials and processing steps ever more susceptible to even smaller contaminants in the environment.

In today’s fab, once harmless molecular contaminants can now damage surfaces and interact with energy, moisture, and other chemicals in the environment to create hazes on optics, attach to wafers, and even contaminate the minienvironments that were designed to protect them.

“It’s an evolving field,” admits Mark Camenzind, senior technical advisor in the Fremont, CA-based Balazs Analytical Services office of Air Liquide Electronics, an international industrial group specializing in semiconductor, industrial, and medical gases, chemicals, equipment, and related services. “As airborne molecular contamination (AMC) gets better controlled and analyzed, we’ve come to realize that it is hard to control completely. It’s like peeling an onion. Underneath every layer is another layer, and something else for us to learn.”

Unfortunately, while advances in manufacturing are allowing fab manufacturers to shrink their technology and produce more complex components at the micro scale, the tools used to battle contaminants in these manufacturing environments are not evolving as quickly.

“A complete and universal fix for AMC is still elusive,” says Steven Rowley, molecular contamination product line manager for Particle Measuring Systems, a manufacturer of air, gas, and liquid particle counters in Boulder, CO, “but companies are taking a more serious look at molecular contamination monitoring and control strategies to mitigate risks.”

Jitze Stienstra, director of product marketing in the San Diego, CA office of Entegris, whose contamination control solutions business unit specializes in these issues, agrees. “Contamination control is becoming increasingly important as decreases in line size mean more processes are affected,” he says.

Stienstra believes a multi-tiered approach to “total contamination control” offers the best solution. The combination of pre-filters for clean ambient air, chemical filters at the tool level, and point-of-use purifiers for purge gases in highly sensitive enclosed environments that cannot come in contact with ambient air, leads to the most robust system. “It starts with the fab ambient, then it goes to the tool level and the micro level,” he says.

Fab operators are also relying more heavily on real-time monitoring to get a more accurate sense of what, where, and when contamination is creating problems in the fab, particularly around photolithography tools.

“Every solution has to be customized to the needs of the fab so that operators can manage contamination and solve problems in an affordable environment,” Stienstra says.

Photolithography blazes a trail

The wafer manufacturing industry is quickly reaching the point where ambient air, even filtered ambient air, cannot be controlled enough to prevent yield loss in the cleanroom environment, so people are going more to cluster tools, enclosed environments, front-opening unified pod (FOUPs), and purge gases to avoid AMC exposure altogether. “Purge gas can be made very clean through purification, which means you don’t have to test it as often, vs. ambient air, which changes hourly and ideally would be constantly monitored,” says Camenzind. However, continuous monitoring at the low levels required by the International Technology Roadmap for Semiconductors (ITRS) is not always available, e.g., for sulfur oxides at pptv levels.

Acidic gas contamination from organic acids such as sulfonic acids can create particularly costly contamination problems if not controlled in the fab because of their reactivity with a number of other chemical species, says Rowley. This reactivity often occurs on surfaces that are very sensitive to contamination, including optical components within photolithography steppers and scanners. “In close proximity to the reduction lens’ final optical element, these species can play a significant role in the formation of films that can potentially adhere to and contaminate optical surfaces,” he says. “Not only can this contamination cause drifting of critical process parameters due to lens contamination and optical hazing, but also terrific costs may eventually be incurred in order to replace contaminated optics in steppers and scanners.”

Acidic gas contamination can also have detrimental effects on cleanroom materials, which may indirectly affect product surfaces, such as filters, sealants, epoxies, and plastics used in tools and components. For example, small amounts of acidic gases in the air, specifically hydrogen fluoride (HF), can cause HEPA filters to accelerate the release of boron.

Nowhere are these problems more of an issue than around the highly sensitive and extremely expensive photolithography tools, which are getting the most attention from contamination control experts because the optics cost millions of dollars to replace or repair and can lead to significant tool downtime and production loss, since the lithography tools are often rate limiting. For these surfaces, the AMC can become surface molecular contamination (SMC) when it either absorbs directly or reacts with light or other molecules to deposit on lenses, leading to optical problems not easily solved.

“In 300-mm fabs, most lithography tools have tracks connected to steppers with an enclosed FOUP-in and FOUP-out,” says Camenzind. “There is no direct cleanroom air exposure anywhere in the sequence,” and wafers only see air that is well purified by AMC filters.

Even so, molecular-scale particles and chemicals in purge gases or scrubbed ambient air can still allow for some surface contamination.

“SMC is a big issues for optics, steppers, lasers, and masks,” says Camenzind, who notes that even trace volatile contaminants, which normally wouldn’t stick to surfaces, can decompose, leaving a residue that ultimately causes hazing. Adding to the risk is the fact that many volatile compounds don’t get trapped in typical absorbents so it’s difficult to accurately assess their levels.

And as the tools utilize light at shorter wavelengths to accommodate smaller feature sizes they become more susceptible to contaminants from ambient air. “It only gets worse with extreme UV,” Camenzind says. “Previous wavelengths couldn’t break down these compounds, but in the future, they will break down everything and masks will have to be used in a vacuum.”

Issues that become more severe at smaller wavelengths include organic compounds reacting with light; refractory compounds leaving residues; and O2 and H2O absorbing light and assisting in haze formation on optics, which decrease imaging performance and lead to expensive repairs or even warranty invalidation.

“There is more concern about refractory compounds causing lens hazing then ever before,” notes Luke Lovejoy, manager of the analytic chemical laboratory in the Austin, TX office of Freescale Semiconductor, a provider of embedded processing and connectivity products to the automotive, networking, and wireless communications industries; and a member of the wafer environment contamination control subgroup of the Yield Enhancement Group of the ITRS.

Steppers generally have point-of-use chemical filters to scrub the ambient air before it enters the tools, but Lovejoy points out that they are not always enough. Many tools also blow purge gases such as high-purity nitrogen and compressed air, which are unlikely to have refractory compounds in them, across lenses with a slight vacuum to prevent contaminants from coming in contact with lens surfaces. This limits the risk of contaminants getting into the critical areas, but even in those scenarios, says Lovejoy, you can get some gas diffusion.

Purge gases are a popular choice because they are easier to control than ambient air, but they are themselves a potential source of contamination, including volatile and semi-volatile organics, volatile acids and bases, and refractory silicon and sulfur compounds.

“Every year is a new learning experience and there is a lot we still don’t know about hazing,” says Lovejoy. “People are working on developing tools to assess these compounds, but it could take years.”

Camenzind also points out that filtered air is still far more economical when it works, and it remains a viable choice for non-critical areas of the fab, such as pre-etching steps when wafers are less sensitive to contaminants. “You are stripping that layer off anyway,” he says.

Manufacturers drive change

Tool makers have had the most profound recent impact on the industry’s ability to understand, manage, and mitigate contamination thanks to stricter warranty requirements for contamination control. In order to maintain full warranty coverage for steppers, manufacturers require tool owners to meet explicit contamination specifications and validate that those requirements have been met.

“Most tool manufacturers require AMC at certain levels to meet warranty requirements,” Lovejoy says. “They also demand that operators use their accredited labs to measure levels or be able to prove that their internal labs are meeting warranty requirements.”

Meeting those requirements isn’t easy. It takes rigorous monitoring and stringent control methods, but it’s worth it because replacing these optics runs in the millions and even tens of millions of dollars–and neither the vendor nor the operator wants to take on that out-of-pocket cost.

Not only is there the hard cost of the lens, which can fall to the fab operators if they can’t prove they adhered to warranty requirements, but also the huge impact on production due to downtime for lens replacement and the challenges of removing the lens, which can weigh a ton and require a crane to move.

“The warranty requirements are driving the industry to do a better job,” says Particle Measuring Systems’ Rowley. “It’s forcing the industry to understand the impact of molecular contamination and value of contamination control strategies.”

Lovejoy agrees. “It’s helping to quantify the return on investment for the photolithography people,” he says.

It also may act as a lesson for other areas of the fab that may not currently be so susceptible to contamination risks, but that may be facing greater sensitivity in the future as shrinking geometries make other process steps more fragile.

“Photolithography has driven a lot of change and there are lessons to be learned from what they’ve gone through,” Lovejoy says.

“We see more and more process steps requiring additional contamination control steps,” adds Stienstra of Entegris, who predicts that optic metrology steps will be the next big contamination risk area, particularly below 65 nm. “We expect the number of contaminants that cause problems to increase, and the limits to decrease.”

Don’t be FOUPed

When materials aren’t in processing, FOUPs, pods, and reticle boxes are being used more commonly as a way to prevent delicate wafers and masks from coming in contact with contaminants in ambient air, but they too run the risk of creating new contamination issues through outgassing of the enclosure and carryover from past processes, which must be carefully controlled.

Camenzind points out that everything in the fab, from the materials and lubricants used on tools and containers to the process steps themselves, has the potential to create contamination that can impact yield.

“Whenever you find a solution you have to be sure the cure is not worse than the disease,” he says.

“Reticles and wafers can still be affected by molecular contamination during processing and storage,” agrees Jürgen Lobert, director of Entegris’s Analytical Services in Franklin, MA. “It’s not just happening in the tools. You have to look at everything.”

Stienstra adds that reticles are a bigger contamination concern than wafers because of the high cost of cleaning and/or replacing them. “To prevent reticle haze, reticles must continuously reside in an extremely clean and dry environment from the moment they arrive at the production fab.”

In the past year, he says, more emphasis has been placed on identifying the contaminants that cause reticle haze and how to prevent it. “There are 30 different species of molecules that cause haze, and they are all enabled by moisture,” says Stienstra.

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He notes that Entegris currently offers a product line designed to prevent reticle haze in 193-nm lithography (see Fig. 1). The solution provides a continuous cleansing environment for the reticle, preventing the formation of haze by controlling and purifying the environment around the reticle between uses. The central element in the system is the integrated purifier and purge capability in the pod. The pod is purged in the stocker and again near the scanner where the reticle will be used.

Stienstra estimates that fabs can realize a four- to five-fold increase in mean time between reticle cleanings by using this system.

“Reticle haze is a multimillion dollar problem,” he says. “We find that fabs see a return on investment in a matter of months.”

The FOUPs also create problems because they can absorb airborne molecular contaminants, such as bromide from wafers, and outgas them onto other wafers. There is also the risk that wafers can contaminate slots in the FOUP. For example, copper contamination on the edges of wafers can carry over to the slots of the FOUP, contaminating the next wafer to be placed in that slot, says Camenzind, who believes the industry needs to embrace more stringent testing of the cleanliness of FOUPs to prevent cross-contamination. This is a new key focus for the ITRS.

Unfortunately, the industry hasn’t come up with the perfect solution and is still looking for tools to better quantify AMC in the FOUPs. “We are looking for abatement methods to measure, monitor, and purge the FOUP before issues arise,” Freescale’s Lovejoy says. “But it’s a challenge.”

Currently Lovejoy, and most other fab operators, must measure outgassing from FOUPs in a lab and wait hours or even days for results. “I want an analytical tool that is sensitive enough to measure the FOUP in real time,” he says, noting that several vendors are currently working on such solutions.

He also notes that operators and vendors need to do a better job of assessing the materials FOUPs are made of–from evaluating their potential offgassing and choosing materials that won’t absorb chemicals to selecting products that are easy to clean.

Go with the flow

Beside the enclosed environments, fab operators must also keep a close eye on their overall cleanroom environment and pay close attention to airflow, says Keith Kibbee, a mechanical engineer in the Portland, OR office of CH2M HILL, a full-service engineering, construction, and operations firm. Kibbee, who does 3D airflow modeling for cleanroom clients, notes that changes in the cleanroom (such as the addition of a new piece of equipment) can throw off the airflow, causing blockages or ripple effects, impacting fan filter unit airflow rates, and limiting optimal recirculation of air.

“In cleanroom remodels, I see a lot of bigger toolsets coming into the chase return and the expansion of clean space, which can create pressure problems and airflow migration,” he says.

Kibbee helps clients map out the impact of new tools or room changes using 3D modeling to identify airflow problems before they arise or to assess the effectiveness of possible solutions before they are implemented.

“You have to tweak the room to control negative factors, and the nuances are minute,” he says. “I can run 10 different cases to see which is the best fit. That would cost a lot more time and money to do it real time.”

One eye open

No matter what solution, or combination of solutions a fab uses to prevent, control, or mitigate contaminants, it all hinges on monitoring. And as smaller and lower levels of contaminants pose bigger risks, real-time online monitoring is becoming the norm–at least around critical processing and handling steps.

“You have to monitor something to know it’s there,” says Particle Measuring Systems’ Rowley, who predicts an ongoing shift away from periodic sampling to real-time high sensitivity monitoring in critical areas of the fab. “Once you monitor, you can correlate the data to your process yield, warranty requirements, the cost of downtime, and maintenance costs. If companies can get a handle on that data, they can see the value of monitoring.”

Some techniques available for monitoring molecular contamination in the air and on surfaces include ion mobility spectrometry (IMS), surface acoustic wave (SAW) monitors, impingers, and sorbent tubes. Particle Measuring Systems offers an extremely sensitive, part-per-trillion, real-time monitor that uses IMS technology to measure AMC before it can react with other compounds and accumulate on critical surfaces such as optics and reticles (see Fig. 2).


Figure 2. The AirSentry II surface molecular contamination monitor uses ion mobility spectrometry to measure contamination at ppt levels in real time. Photo courtesy of Particle Measuring Systems.
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“Because AMC and SMC can fluctuate wildly throughout the day or manufacturing cycle, relying on periodic sampling may not deliver the most accurate information,” says Rowley. “Without real-time data, it is not possible to understand if AMC or SMC levels observed in the air or on optics, reticles, and wafers represent stable background conditions, a contamination event, or a low or high phase of a daily contamination cycle.”

Balazs’ Camenzind agrees that the trend is toward more routine online monitoring, particularly for ambient air which varies from day to day. However, he notes that in critical areas today’s online monitors may not be sensitive enough to give accurate readings at pptv levels.

“SO2 online monitoring works for makeup air, but after purifiers levels are required to be much lower, and online instruments do not have adequate sensitivity, so you still also need to do ‘grab sampling’ to get the lowest detection limits needed by the ITRS and stepper manufacturers,” he says. “Steppers, masks, and lasers all have similar and severe purity requirements in the sub-parts-per-billion to parts-per-trillion by volume range.”

He also urges fab operators to conduct routine air analysis for urea, a base that can contribute to photoresist problems, in addition to the usual suspects such as ammonia, amines, and amides.

“The only way to identify which contaminants will impact processes is with state-of-the-art measurement and sampling technology,” agrees Entegris’s Lobert. “Today’s applications require consistency and repeatability over time in the parts-per-trillion concentration range.”

Finding balance

“It’s a competitive advantage for companies to know how to manage and handle molecular contamination in the cleanroom,” says Rowley, who suggests that the industry has not gone as far as it should. “Most companies hold their AMC monitoring and control techniques and strategies close to the vest, because those who do it well gain critical tenths of a percent to a few percent gains in yield–which make huge differences in such a competitive industry.”

“In the end, reaching the extreme of no contamination whatsoever doesn’t make financial sense,” says Camenzind. “The most practical contamination control engineering is figuring out what the reasonable limit for each step is based on the process, then maintaining levels below that limit and monitoring to ensure you achieve it.”

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The trick is figuring out exactly what those levels are and developing the tools to monitor and mitigate to these levels to ensure the environment is protected.

“It all boils down to yield and dollars,” says Rowley. “Most companies don’t have a good handle on the cost of poor contamination control and they may not know how much they are spending.” He explains, “Considering the costs associated with outfitting cleanrooms and lithography tools with chemical filtration and purge gases, costs of 193-nm lithography equipment downtime, as well as the additional costs embedded in warranty and service contracts, outfitting a cleanroom and 193-nm lithography tools with a complete AMC monitoring solution is minor in comparison.”

But as geometries continue to shrink, fab operators need to get a quantifiable measure of what contaminants impact their processes and how much that impact costs. Only then can they make an accurate assessment of the costs and benefits of contamination control decisions.

“Contamination is not going to be 100 percent controlled in our lifetime,” says Camenzind. “We’ve learned a lot about contamination control, but we still have a long way to go. Working together in interdisciplinary, multifunctional groups like the ITRS is essential to making the most progress in these areas, to keep the industry on track with Moore’s Law and new technologies.”

Contamination monitoring bolsters semiconductor manufacturers’ efforts to keep up with shrinking critical dimensions and cost and energy reductions

By Morgan Polen and Bill Shade, Lighthouse Worldwide Solutions

Contamination control in today’s production facilities is specifically targeted at loss prevention, cost reduction, and process control. As critical dimensions shrink and pressure increases for cost and energy reduction in manufacturing, contamination monitoring can be a useful tool to ensure that the cost reduction measures do not impact the production environment.

Various contamination monitors have been used in the past as indicators or watchdogs for contamination events. These have informed facilities, equipment, or process personnel about changes in contamination levels.

These same instruments are starting to be used to fine-tune the facilities, equipment, and utilities for cost and energy reduction. From the high purity water systems and bulk gas systems to the air handling systems and the air itself, contamination monitoring has become a more useful tool in cost and energy management.

Particle monitoring has long been a part of contamination control in semiconductor manufacturing. Optical particle counters are used to measure particle levels in the cleanroom ambient air environments as well as the gases, water, and chemicals used in the manufacturing process. As semiconductor manufacturing advances, new requirements are placed on optical particle counting technology and monitoring systems. This article explores some current trends in semiconductor manufacturing, optical particle counter technology, and monitoring systems, as well as contamination control applications in modern fabs.

Airborne particle counting

The ambient environment in today’s semiconductor fab is often comprised of a centralized cleanroom and the minienvironments for the process tools. This approach provides a high level of isolation that prevents contaminants from entering the wafer processing area. The cleanliness of these environments is strictly controlled to ensure that contamination does not impact yield and throughput in the manufacturing process.

Most fabs certify cleanliness periodically according to the ISO 14644-1 standard. In addition, today’s semiconductor manufacturing facilities frequently employ a centralized particle monitoring system for monitoring particle levels in the process tool environments. Typically these systems include multiple remote particle counters sampling in real time from several locations simultaneously or a single particle counter sequentially sampling from multiple locations via a manifold. The particle sensitivity of the instrument utilized depends on the cleanliness levels of the environments that are monitored.

The real-time application of remote particle counters places extreme requirements on the design for lower cost and high reliability since a fab typically employs a significant number of these in a monitoring system. In addition, as these instruments are used to monitor inside minienvironments, process tools, or stocking systems, their size can often become an issue. Figure 1 shows a 0.2-µm remote particle counter that can be used as part of a real-time monitoring system. The current state-of-the-art remote particle counters can have laser diode lifetimes of 20 years or greater.

A sequential sampling manifold system includes a manifold and portable particle counter. The manifold contains several ports that are connected to individual tubes routed to various locations in the fab. Figure 2 is a layout of a sequential sampling manifold system. The manifold mechanically samples from the various ports and delivers the sample to the portable particle counter. The current trend with these systems is to be able to control sample locations down to a few particles at 0.1 µm. Therefore, the manifold must be very carefully designed with flow efficiency in mind and no right angles in the flow path. This approach allows for better particle transport. In addition, the design must not generate any particles from either the internal mechanisms or from cross-contamination.

The portable particle counters employed in these systems are often used interchangeably in numerous other fab applications. These universal instruments are used as portable devices in a cleanroom monitoring plan or can be used for troubleshooting particles in a particular process tool or area. In addition, these devices are used for measuring particles in gases on-line or in a portable manner. Because these instruments are used in so many applications throughout the fab, they must be portable in nature and, as such, be as lightweight as possible and capable of running on a battery. They also must be easy to operate for personnel who are required to use them on infrequent occasions.

Today’s semiconductor manufacturing is composed of fully automated material handling and process equipment as well as minienvironments for isolating the product at all times from the central facility. These advances in the manufacturing process have created the need for optical particle counting instrumentation to facilitate the measurement of particles in minienvironments and stockers as well as to facilitate the troubleshooting and monitoring of complex automated process equipment. The result has been the advent of smaller sampling devices that permit the sampling of a handful of locations in a minienvironment, stocking system, or in and around a process tool using a single portable particle counter. Some of these devices use an ensemble averaging technique to draw in the sample from multiple locations simultaneously. Such sampling techniques cannot identify the specific location of the particle source. Other devices use sequential sampling techniques to monitor multiple locations. These devices have the ability to easily partition the particle measurement between different locations, helping pinpoint the source of particle issues rapidly. Figure 3 is an example of one such sampling device, which permits multipoint sequential measurement in a portable manner.

Gas particle monitoring

Another potential source of particle contaminants that can affect semiconductor product is the bulk gases used throughout the semiconductor manufacturing process. For this reason, many leading-edge fabs monitor critical high pressure gases for particles on-line. Historically this has been accomplished using particle counters specifically designed for measuring high pressure gases or using airborne particle counters in conjunction with high pressure diffusers. Current particle counters for measuring high pressure gases have relatively low flow rates and limited sensitivity. In addition, the complex design required for high pressure gas measurement results in a high cost-of-ownership due to periodic maintenance costs. High pressure diffusers use an orifice or series of orifices to reduce gas to atmospheric pressure. As such, these can be easily contaminated and can have long cleanup times. In addition, high pressure diffusers typically exhaust a significant percentage of the gas sampled, which is an added cost for this method of sampling.


Figure 1. Remote particle counters, such as this 0.2-µm device, can be used to monitor inside cleanrooms, minienvironments, process tools, or stocking systems as part of a real-time monitoring system. Photo courtesy of Lighthouse Worldwide Solutions.
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As the industry moves to smaller linewidths, there has been a drive to improve the performance of optical particle counting instrumentation for gas sampling, including the sensitivity and sample flow rate. Recent advances in gas-sampling optical particle counting technology include the development of high pressure controllers. These devices reduce the pressure of the gas to atmosphere without any wasted gas and are less prone to contamination than high pressure diffusers. In addition, these devices have extremely short cleanup times. The result is efficient, reliable on-line gas measurement at 0.1-µm sensitivity and a 1.0 cfm flow rate using a universal airborne portable particle counter described previously.

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In addition, because of the simplicity and rapid cleanup of these devices they can now be used easily in portable applications like checking incoming gas quality and filter performance as part of process tool startup and qualification. The use of these devices for tool startup and qualification can be expected to dramatically reduce startup costs and time.

High-purity water particle monitoring

In a typical fab several thousand gallons of high purity water come in contact with each wafer. For this reason, the output of the main high purity water plant is monitored extensively for several forms of contamination to ensure that the water does not impact product quality. Particles, TOC, dissolved oxygen, and silica are some of the forms of contamination monitored. The 2007 International Technology Roadmap for Semiconductors (ITRS) states the recommended particle levels at 50 nm are 0.3 particles/ml. This specification places extreme demands on the design of instrumentation to measure particles at these sensitivities and low concentration levels.

There are several industry trends that are likely to shape the future of particle monitoring for high purity water. Water conservation is one trend. The industry is developing specific goals to reduce incoming water consumption in the years to come, which is likely to lead to more recycling and reuse of water where possible. At the same time, local water purification solutions are emerging for specific processes where the purity of the water is critical. These trends are likely to drive the need for additional monitoring including point-of-use monitoring in key process steps.


Figure 3. A minienvironment monitor that uses sequential sampling techniques helps monitor multiple locations, easily partitioning the particle measurement between different locations. Photo courtesy of Lighthouse Worldwide Solutions.
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In response to these changing requirements, optical particle counting instrumentation is advancing to reduce the background zero count levels to improve measurements at current and future concentration levels. In addition, instruments are now available that are truly portable so their application can be extended beyond the main DI plant into the fab and process.

Chemical particle monitoring

Optical particle counting is also used to measure particle levels in critical chemicals that are supplied to the fab by the bulk chemical delivery system. Current measurements are made at 0.065 and 0.1 µm with existing instrumentation. As the industry moves to smaller device geometries, it places demands on the instrumentation to improve sensitivities and/or background levels to provide reliable measurements in the near future. Given the current ITRS recommendation for critical particle size and number of particles, a 0.065-µm particle counter must measure particle concentrations at or below 1 particle/ml today. Clearly liquid particle counter instrumentation must continue to advance to meet the industry’s needs.

Fab-wide environmental monitoring systems

Fab-wide monitoring for particles and other environmental parameters is commonplace in most fabs today. These computer-based systems are composed of the various instruments previously discussed and other environmental instruments connected into a centralized data acquisition and analysis hardware and software system. Historically these systems have been used for environmental monitoring of the cleanroom.

At present, a number of additional applications for these systems are emerging that are in part being driven by a need to reduce costs and energy consumption. One such application is continuous monitoring per ISO 14644-2. ISO 14644-2 states that if a continuous or frequent monitoring system for particle counts and differential pressure is employed and these parameters are within the specified limits, then the cleanroom is in a state of compliance and does not require bi-annual or annual recertification. Therefore, users are starting to employ these continuous or frequent monitoring systems as part of their monitoring plan to reduce certification costs.

Another application that is being explored is realizing energy savings by using particle counts as feedback to control air handling units, thereby reducing energy consumption of the air filtration as much as possible. Given the cost of energy today and the present concern about preserving our global environment, this is an exciting application for these systems that is sure to be realized in the near future.

As fab-wide monitoring systems are utilized for more advanced, mission-critical applications, it drives the need to improve the overall performance of these enterprise systems. These systems must maintain higher uptimes, and that is now being realized through a number of system features being put in place.

At the instrument server data acquisition level, redundant controller architecture provides assistance in the event of any hardware or software failure on the main controller. At the database level, a clustered database deployed on multiple machines can dramatically improve the uptime of the database engine.

Another improvement in these systems is the development of open standardized interfaces. Modbus is commonplace at the data acquisition level and OPC is often an available interface to the data and instruments. These open interfaces permit these systems to be readily interfaced to building management systems that may need to perform advanced functions such as controlling fan filters or air handlers based on the collected data.

Summary

Semiconductor manufacturing is continuously changing as device geometries shrink in an effort to reduce cost and improve device performance. As the industry moves to smaller linewidths, there is continued focus on contamination control, including the use of optical particle counters and their fab-wide monitoring systems. The industry’s continuous adoption of these instruments and systems is in turn driving investment in the innovation of the technology and its application to realize additional cost savings and yield improvements.


Morgan Polen is vice president of applications technology and Bill Shade is vice president of marketing and engineering at Lighthouse Worldwide Solutions, headquartered in Fremont, CA (www.golighthouse.com). They can be reached at (510) 438-0500.

To maximize containment, all aspects of the glove and sleeve must be routinely inspected and tested

By Russell E. Krainiak, Integrated Containment Systems

As an isolator designer and builder ultimately responsible for operation, the question of the glovesleeve as a weak link is very complicated for this author. The application drives the wear, age, and how an operator performs the tasks to determine when a glove should be changed. A typical pharmaceutical user will ask “How many months?” in trying to determine when the glovesleeve is to be changed, but it isn’t that easy to determine from case history. The technology is still new to this particular industry that likes to know up front every detail of what to expect.

The intent of this article is to provide some of the details of glovesleeves, gloveports, and maintenance for keeping glovesleeves safe, thus keeping the entire operation safe and controlled. Testing is a very simple maintenance task, but some companies do not test the gloves and glovesleeves; examination is important, but they often are not examined. There are other factors to prevent actives from egress of an otherwise robust containment system. These will also be discussed.

Background

The nuclear industry has used gloveboxes for more than 40 years. In the early years, the glovebox was a necessary device to allow access to radioactive materials for the purpose of making and servicing a weapon. The nuclear industry shares many of the same problems as the pharmaceutical industry. Glovesleeves are used to access almost everything these technicians process and similar disciplines share the same concerns. If a glove leaks, will the product escape?

The first nuclear gloveboxes were transitioned to isolators by the manufacturers. There were many design changes to accommodate cleaning, which was not as critical in gloveboxes. Cross-contamination was not as much of a concern since the glovebox product was very different. The failings of gloves always raised the same questions: when, where, and why did it happen?

Some gloves on nuclear gloveboxes have been in place for five years without leaks. As demonstrated in papers presented and forums from the American Glovebox Society (AGS),1 this length of time before failure is possible with proper maintenance and sometimes by limited use. Training is cited as being critical to the safety of the operator.1 Some glovesleeves leak starting out of the new package, which most likely occurs due to storage problems.


Figure 1. Today’s isolators incorporate test programs to ensure glove and sleeve viability. Photo courtesy of Integrated Containment Systems.
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One thing the nuclear industry understood from the history of glovebox usage was leaks can contaminate the room, the facility, and the outside. Monitoring equipment is used so operators cannot leave the facility without being cleared. There are other reasons for monitoring outside the scope of this article; if a glove has a hole or tear, the risk is imminent. Most pharmaceutical facilities do not routinely perform tests that detect active pharmaceutical ingredients (APIs) for operators working in the containment facilities. Some operations do require blood tests to determine past exposures, since it is the only way to determine exposure. Operators can go home, spend time with the family, and potentially spread APIs. For this reason, the pharmaceutical isolator must have certain additional safety features and qualities.

Glove materials and types

There are several glovesleeve designs and materials available for gloves. Deciding which is appropriate for an application is dependent upon the application. Hypalon, neoprene, and butyl are the most commonly used glove materials that withstand many cleaning chemicals. Chemical damage can occur and should be considered in the design phase. All chemicals–cleaning and process–should be checked for resistance with the gloves to be used. As an example, researchers use multiple chemicals in isolators as part of their daily operations. Every chemical should be checked against the materials of glove construction just like the isolator seals. Sometimes the gloves can be changed to another material, but there are some chemicals that degrade all available glove materials. For this reason, manufacturers maintain resistance charts as part of their web sites and company literature.

Another factor to consider is mil thickness of available gloves. A thin 15-mil glove is chosen for dexterity when doing intricate weighing (such as analog weighing). When the technician will perform scooping operations from a drum, a thicker 30-mil glove is chosen for its robustness.

Operations dictate the selection of glove type and thickness but also consider hand size. Multiple operators are another variable in the design, with hand size and dexterity as factors. The gloves are available in ambidextrous and left-right hand types. After the material is selected, the designer has to choose the type of glove, thickness, hand size, and whether it will be a left-right hand type. Note that some glovesleeve manufacturers only offer their gloves in certain sizes. When choosing a glove for multiple operators, the tendency is to go to a larger glove size to accommodate more users. Another type of glove is the changeable hand type. This allows changing only the hand glove portion of the assembly; the sleeve stays with the gloveport and allows more variety of hand sizes than a single-piece glovesleeve arrangement.

Gloveports

The gloveport is the attachment for the glove and is critical to the life of a glovesleeve. Friction from movement of the glove against the ring can lead to holes and tears. Most of this friction is caused by ergonomic problems that may have been designed into the isolator or result from continuous usage. Isolator manufacturers generally have proprietary designs that range from 8- to 14-inch diameters. Both oval and round versions are available. Most operators favor a large, round gloveport that provides more side-to-side and up-and-down movement. The first gloveports used on gloveboxes were 8 inches since shielding an operator’s chest was critical. Pharmaceutical workers can use much larger versions because they spend more time working in the gloveports and do not need radiation protection.

The two factors that lead to failure are repetitive motion and finger contact areas. These wear areas, like tires touching the road and wearing, are generally at the fingertips, which see the most contact and will eventually wear holes through the glove. One company manufactures a white-coated Hypalon urethane material that is a dark blue color. When the Hypalon wears off, this indicates the glove should be changed. The area where the glove constantly rubs against the ring is another wear point and should be examined and tested routinely; this is especially true for extreme reaching in an isolator. In the design phase, constructing a simple mockup to evaluate ergonomic problems in this area will allow design adjustments to be made accordingly.

Testing

Everything that fails does so for a reason. In the case of a glove, this is generally caused by repetitive wear or physical damage. What tests are available, how can you test a glove installation, and what is the best way? First you must understand how the glove works in an isolator.


Figure 2. Oval gloveports limit horizontal movement. Photo courtesy of Integrated Containment Systems.
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A glovesleeve is maintained for containment isolators under a slight negative pressure, usually less than 0.5 inches water gauge during production. The pressure is imposed by the pressure drop across an inlet filter set up to flow around 100 fpm through a breached gloveport (“breached” meaning a glove completely removed for testing purposes). Although there is some pressure surge with an isolator, it doesn’t normally damage most glovesleeves. When gloves are moved for entry into a set of ports or exiting the ports, there is a surge that shouldn’t bring the negative pressure to a positive pressure but will be very close. If a leak exists in a glove, this is the moment that particles could penetrate through the hole, depending on size of the hole and the number of particles. Depending on the operator exposure limit (OEL) over time, an operator could be exposed to harmful amounts of substances. The size of the hole and how much can egress through it and at what velocity also varies. This is the justification for testing glovesleeves prior to use.


Figure 3. Round gloveports offer better range of motion. Photo courtesy Integrated Containment Systems.
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Pressure is the most widely used method of testing gloves. Some will insert a plug on the outside of the ring and seal it. This is the best test method since it challenges the entire gloveport assembly in the installed, ready-to-go state. Pressure is applied to the plug and time is used to determine a preset pass/fail condition. Some test systems only challenge the glovesleeve, requiring the existing glovesleeve to be removed in order to perform the test, which works best with a new glove installation. The system uses pressure as well, but, again, only the glovesleeve is being tested, not the ring seals that lock the glovesleeve to the gloveport.

Following on the recommendation for daily testing of gloves used for low OEL applications, the trend has been to automate a glove and isolator pressure integrity test at startup of an isolator, prior to production or use. This can be a very simple way to maintain the safety of the operator; it allows a PLC to perform these testing functions by pre-validated pass-fail parameters. A PLC, unlike an operator, runs to a pre-validated program in a consistent manner that is not changed by the operator. The manual setup of an isolator for testing leaves room for error by depending on standard operating procedures (SOPs) being performed consistently. Most isolators that are set up manually are used for higher acceptable exposure applications. A PLC pressure integrity test for leaks is as simple as using the blower and inlet-outlet control valves to encapsulate the volume of trapped pressure. This helps identify the leaks on the isolator and glovesleeves. If it is determined that a leak exists for the glovesleeves, the next challenge is to determine which glovesleeve is leaking. A plug can be placed into the gloveport and sealed. A pressure line runs to a transducer to measure the pressure trapped in the glovesleeve and gloveport cavity plug. If the cavity shows negative pressure, it is leaking; if not, it is functional. These parameters can be set and controlled by the safety personnel. Using PLCs to perform the test function reduces time and money spent on testing and ensures the safety of the system. The other advantage, based on actual users in isolators, the unit passes the test most of the time, negating a “find the leak” element of the test since the glovesleeve is tested with the isolator as one volume.

Isolators

Isolators are predominantly built from stainless steel, with welded and sealed construction that can maintain the pressure boundaries that separate the worker and the API or hazard within. The openings, predominantly gloveports, are susceptible for one reason: This is where the wear and movement take place. The design of the isolator can add to the wear of the glovesleeves since a design that is not ergonomic can lead to stretching, yielding damage to elastomeric glovesleeves and tears that could result in exposures. Although the available materials are quite robust, continued and repetitive movements will lead to early replacement of glovesleeves.

Another glovesleeve failure observed by pharmaceutical companies includes extreme negative pressure, operating at around <1 inch water gauge. The excessive pressure will fatigue the operator, who must struggle with the glovesleeves for even the simplest movement. In this situation, the operator will have failures based on certain fatigue areas where creases are created and continually fold in the same location.

Training

Training is essential for any new installation and new technology. Training is conducted by the isolator suppliers because they are equipped to understand the operation and maintenance of the equipment. The weak link is how to do it safely regarding the gloves’ weaknesses and strengths. This supplier training is rarely conducted in any detail for each custom isolator project.

General training for operators is provided by the AGS at its annual conference. Attendees learn physical anthropology, how to work in a glovebox/isolator to avoid injury, and how to maintain the safety of the unit. Since many smaller pharmaceutical operations are not equipped to perform training within their facilities, this specialized training is a good start. Key information is given on how to visually examine gloves, how to avoid moves that might lead to glovesleeve damage, and safety related to glovesleeves. While this is a good starting point for a general “how to” training, it cannot replace understanding the specific equipment operations and procedures.

As noted, PLC control is used to incorporate most of the SOPs in the isolator program by the manufacturer and the user. This can further reduce training and operator setup responsibilities. Many programs include a safe setup or alarm for any failure. For example, if the isolator fails the pressure integrity test, the operator cannot use the equipment until it passes. The PLC simply locks out the operator. In the case of a leaky glovesleeve, the isolator will have a screen for pressure testing the gloveport and sleeve with the tester. Otherwise, an operator might use the isolator in an unsafe condition and risk exposure. This is common with older isolators that used manual operator setup. The operator could use the isolator without realizing a hole or tear exists on the glovesleeve.

Conclusion

To maximize the safety of the operator and facility, training, testing, history, and good isolator design features must be incorporated into a high-level containment system. Glovesleeves are fairly robust in most isolators and have been used for years by both the nuclear and pharmaceutical industries to successfully contain product. The pharmaceutical industry has a greater challenge in preventing egress of its products from the facilities. Gloves should be tested daily during production runs, along with visual examination to determine viability. Isolators should never be used if a leak is found as the risk is too great. PLCs should be used for any low OEL active, and a program should be established to minimize SOPs dealing with isolator pressure integrity testing and with glovesleeve/gloveport testing. This is the safest method and provides the greatest cost savings over time compared to manual testing with gauges and SOPs. The activity in the isolator, not necessarily the length of time on the isolator, will dictate how long the gloves remain on the gloveports. The other factor mentioned regarding chemical resistance should mandate that the material for the glove is compatible. Some chemicals will actually dissolve the glovesleeve. This failure could be catastrophic if an operator had their hands in the glovesleeves at the time. There is information available for news users from professional societies and technical forums to aid in determining wear and care of gloves.


Russell E. Krainiak is currently director of technology for Integrated Containment Systems, a design and build company of isolation and containment systems (www.integratedcontainmentsystems.com). He can be reached at [email protected].

Reference

  1. M. Cournoyer, C. Lawton, Los Alamos National Laboratory, “Why Good Gloves Go Bad,” pres. American Glovebox Society Forum, 2006 AGS Annual Conference.

ISO 21501 offers standard methodology for calibrating optical particle counters

By Tony Harrison and Bob Latimer, Hach Ultra Analytics, Inc.

ISO 21501 is a new family of standards describing the instruments and calibration requirements for determining particle size distribution using light interaction methods. It represents the culmination of work by instrumentation manufacturers and industry users and comes at a critical time for the life science industry with the increasing trend for real-time air particle monitoring in cleanrooms using light scattering air particle counters.

The ISO 21501 family of standards extends beyond air particle counters to include both scattering and extinction type liquid particle counters. The standard is split into four parts and all are available from ISO at http://www.iso.org.

ISO 21501, Determination of particle size distribution

Deciding what type of disinfectant will provide the greatest efficacy for your application requires a back-to-basics approach.

By Lisa Strickland, Contec, Inc.

It might not be too dramatic to state that bacteria, viruses, fungi, and spores represent a unique, insidious, and dangerous class of contaminants: unique in that under the right conditions the contaminant population can multiply over time; insidious in that these organisms can penetrate into small openings and crevices that can persist for long periods of time; and dangerous in that they can affect human health. So these contaminants must be destroyed and/or removed to achieve the desired cleanliness and aseptic condition. That’s the role of disinfectants.

If there were only one chemical agent–i.e., one disinfectant–available to accomplish our objective, life would be simple. Unfortunately, there are many products to select from. So how do we choose? Do we base our decision on chemical structure? Personnel protection issues? Type of organisms to be destroyed? In this article, we’ll focus our attention on these questions and others.

Chemical agents that destroy microorganisms can be termed “biocides”; it is useful to categorize them in terms of potency. Sanitizers, such as alcohols, can reduce microbial contamination by as much as 99.999 percent (known as a 5-log reduction) but are ineffective against spores. Disinfectants, such as phenolics and quaternary ammonium compounds, provide 100 percent kill of vegetative bacteria, some fungi, and viruses but are also ineffective against spores. To destroy spores and achieve 100 percent kill of all microorganisms requires sterilants–aldehydes or strong oxidants such as bleach or hydrogen peroxide.*

Finding the optimal chemistry for each environment is critical to removing these complex microorganisms.

The great bug hunt

Every facility must determine the resident micro flora unique to each environment. The United States Pharmacopeia (USP) provides guidance on microbial control and testing. Specifically, USP <1072>,“Disinfectants and Antiseptics”1, and USP <797>, “Pharmaceutical Compounding–Sterile Preparations,”2 provide guidance on identifying key organisms in critical areas. Testing to determine the organisms down to the genus and species level is crucial. Identifying the type of microorganisms and the number will provide the framework on which to build a microbial control program.

Now what?

Once the microorganisms have been identified, the cleanroom operator can select the proper biocide solution for the environmental isolates and surface materials. Things to consider:

  • Spores and surface sterilization. Did you discover any spores in your testing? If so, it is critical that a surface sterilant be employed.
  • Personnel safety. Many biocides are eye and skin irritants, unpleasant to use, and toxic. It is very important when choosing the application mode (fogging, spraying, wiping, mopping, or immersion) to be aware that these applications can create situations that are hazardous to personnel.
  • Surface contact time and material compatibility. Dwell times can vary significantly depending on the particular biocide and the specific isolate to be destroyed. The effective contact time can be determined by following the biocide’s label recommended claims or performing an in situ sanitization validation.
  • Chemical disinfectant media. Several formats of chemical disinfectants are available for convenience: ready to use, concentrates, and pre-saturated wipers. Sterile solutions of biocides are commercially available as well. These solutions are aseptically sterile-filtered and/or gamma-irradiated to provide the requisite Sterility Assurance Level (SAL).

There are three important components to chemical selection: chemical effectiveness, compatibility with substrates, and safety to personnel. There are numerous biocides available that can offer a broad spectrum of activity to kill susceptible pathogenic species. Arranged alphabetically, and described more fully below, are some of the most commonly used biocides found in critical environments.3,4

Alcohols are sanitizers commonly used as a skin antiseptic. Of the available alcohols, isopropyl alcohol (IPA) is most often employed. Typical IPA concentrations vary between 60 and 85 percent. Most commonly used is 70 percent IPA, because there is enough water in the solution to allow it to effectively penetrate the pathogenic cell. A minimum contact time of 10 minutes is recommended when using IPA. The quick evaporation of IPA is a major disadvantage as a biocide, because the concentration diminishes before the recommended dwell time can be met. Conversely, because of the volatility, IPA is an excellent option to clean and dry equipment without leaving a residue.5,6

Aldehydes are powerful and aggressive disinfectants that can be used effectively as a sterilant. In concentration aldehydes are highly toxic to personnel and require long contact times for sporicidal claims. A typical aldehyde, gluteraldehyde, can require up to 10 hours of exposure at a concentration of 2 percent to kill Bacillus subtilis. Aldehydes are ideal for use on equipment that can be submerged for a period of time, under conditions that can keep irritating vapors at a minimum. Some countries have banned or restricted the use of aldehydes because of their safety profile as carcinogens.5,6

Inorganic chlorine and chlorine compounds solutions are broad-spectrum biocides that can be used as a disinfectant or a sterilant. Chlorine chemistries are inexpensive, readily available, and relatively fast acting. However, these chlorine solutions are corrosive, unstable over time, and rapidly lose activity in the presence of heavy metals found in the environment. Chlorine solutions have a high toxicity profile and must be used in well ventilated areas. Sodium hypochlorite (NaOCl), the most commonly available chlorine solution, can be found in a range of concentrations from 1 to 35 percent. Typically concentrations for sodium hypochlorite are 1 to 5 percent. A 1 percent solution provides approximately 10,000 ppm of free chlorine. As little as 5 ppm will kill vegetative bacteria. Unfortunately, to kill spores the concentration must be 10 to 1,000 times greater.5

Hydrogen peroxide is a potent biocide that is environmentally friendly because it degrades to water and oxygen. Peroxides are rendered ineffective in the presence of organic and inorganic soils, so pre-cleaning is required to achieve the desired reduction in the microbial population. Disinfection can also be achieved with lower concentrations of peroxides.6 In concentrations as low as 0.5 percent, hydrogen peroxide can be combined with other ingredients to dramatically increase its germicidal potency and cleaning performance. These chemistries are effective with short contact times and offer an excellent health and safety profile.7 Sterilization can be achieved with hydrogen peroxide concentrations of 35 to 50 percent. Peroxides used in the vapor form, vaporized hydrogen peroxide (VHP), are very effective in sporicidal cleaning at low concentrations.6

Hydrogen peroxide blended with peracetic acid (PAA) is very effective at low concentrations and degrades to acetic acid and water. It is more effective than peroxide alone because it is not inactivated in the presence of soils. When high concentrations of this biocide are present, adequate ventilation is required. The combination of hydrogen peroxide and peracetic acid is an unstable solution; therefore, concentration testing must be performed prior to application.6

Phenolics are broad range disinfectants that are used on environmental surfaces. Substituted phenolics (e.g., p- t

Revisions to EU GMP Annex 1 clearly outline appropriate air cleanliness measures to be taken

By Mark Hallworth, Particle Measuring Systems

The Good Manufacturing Practice (GMP) guidance for sterile manufacture was revised in 2003 to accommodate changes from various cleanroom standards to create a single unified cleanroom standard, ISO 14644-1. The introduction to ISO 14644-1 states this as:

Annex 1 of the EC Guide to Good Manufacturing Practice (GMP) provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products. The guidance includes recommendations on standards of environmental cleanliness for clean rooms. The guidance has been reviewed in the light of the international standard EN/ISO 14644-1 and amended in the interests of harmonisation but taking into account specific concerns unique to the production of sterile medicinal products.1

To summarize, the method to certify a cleanroom needed to comply with the rules and format of ISO 14644-1 guidance; this European Commission annex includes a modified ISO standard that addresses sterile medicinal products. To support this, a table of cleanroom certification values that roughly translated to ISO 14644-1 was defined.

For clarity, a series of notes appended the table. Unfortunately, the first, “Note a,” caused some confusion.

This confusion has been remedied in the 2008 release of the EU GMP Annex 1, which clearly outlines three phases that need to be performed:

  1. Certification: Each cleanroom and clean air device should first be classified.
  2. Monitoring: The cleanroom should then be monitored to verify that conditions are being maintained relative to product quality.
  3. Data review: The data accrued from the monitoring must be reviewed in light of the risk to finished product quality.

Certification

To perform the required certification it is important to understand ISO 14644-1 and how to certify a cleanroom in accordance with that standard, rules on number of sample points, sample point location, and volume of sample to be taken at each location, along with the rules on statistical analysis of cleanroom data that need to be followed. However, rather than use the table for classification limits prescribed in ISO 14644-1, technicians should be using the table shown here, as printed in the revised guidance document.

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Other expectations are also defined by the GMP, such as the sample volume for Grade A cleanliness, which should be 1 m3 per sample location, and that a minimum length of sample tubing should be used due to the high precipitation of 5.0-μm particles in transport tubing. Ideally, no sample tubing should be used. Also, recertification of the cleanroom should follow the guidance given in ISO 14644-2–that is, once per year for ISO Class 6 and greater and once every six months for ISO Class 5 and cleaner; concessions are made for extending the ISO Class 5 areas if a monitoring system has been implemented. Suitable times to perform certification are media fills or simulated filling runs.

Monitoring

After the cleanroom or clean air device has been certified, the room must be monitored, relative to risk, to prove that the aseptic manufacturing environment can be maintained and proven to be maintained.

The Grade A zone, which is the environment of greatest potential risk to the finished product, should be monitored for the full cycle of production, including setup. The frequency of monitoring should ensure that any interventions, short-duration events, or general deterioration in conditions will be measured and alarms triggered if alert/action limits are exceeded. This requirement of all events essentially precludes the use of manifolds in these areas due to the sequential nature of the sampling being performed; concessions are made for the use of manifolds if they have been sufficiently validated as suitable for the relevant manufacturing type.

Grade B areas follow the same rules as Grade A. However, the frequency of sampling can be reduced. Grade A is maintained under unidirectional airflow, and so short-burst events may be localized and of a very short duration, excluding some catastrophic failures. However, Grade B is turbulent mixed airflow and reflective of the general environment in which the operators occupy. A low level of continuous particulate activity in this area is normal; and the system’s response is to alarm when general control of this area is out of tolerance. Therefore, an immediate spike in contamination is less likely to have a significant impact on product quality. This becomes more pronounced when looking at background support areas beyond the zone in immediate proximity to the filling line or other Grade A areas.

In the 2003 GMP, there was confusion over the sample required for monitoring the Grade A and Grade B areas due to the phraseology used. The 1-m3 sample was to meet the calculation required by ISO 14644-1 and not a risk-based monitoring value. However, clarity is improved in the revised guidance:

The sample sizes taken for monitoring purposes using automated systems will usually be a function of the sampling rate of the system used. It is not necessary for the sample volume to be the same as that used for formal classification of clean rooms and clean air devices.2

Therefore, a system using a 28.3 L/min particle counter would ideally sample continuously, from setup through the entire filling period and slightly beyond, taking minute-by-minute samples, normalizing data to counts/m3, and setting appropriate alarm and alert limits on the normalized values. The key to monitoring is to be able to respond in a timely manner to events that would show the area is no longer in environmental control.

Data review

There is a relationship between non-viable particles in a cleanroom and the viable contaminants (see USP Chapter <1116>, “Microbiological Evaluation of Clean Rooms and Other Controlled Environments”). There are also studies that show the size of viable particulates free-floating in a cleanroom. When combining these two independent studies together, it is apparent that if the operator can control the large particles in a cleanroom, control over the viable risk in a cleanroom can also be demonstrated. Empirically this is difficult to show due to the statistics of the small numbers generated–that is, <1 particle and <1 CFU. However, the 5.0-μm particle size is of particular importance when reviewing environmental data within the cleanroom.


Figure 1. Lasair III particle counter. Photo courtesy of
Particle Measuring Systems.
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Occasional high counts may be due to interference with the particle counter electronics, although some particle counters have components that reduce these effects as well as the effect of random particles within the cleanroom. Given the fact that random events cannot be interpreted in small numbers with statistical reviews and have very little correlation to the general production activities, they can be reviewed at a later stage when doing longer-term analysis of cleanroom performance. What is key is the consecutive or regular counting of low levels of particulate that may give clues to a possible contamination issue that should be investigated.

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Figure 2 shows three conditions:

  • Continuous: If continuous levels of 5.0-μm particles are seen in a cleanroom, an investigation should be undertaken as it is unlikely that large particles would penetrate a filter. Therefore, the contamination is arising from a source that can be contained.
  • Frequent: When large particles occur with a frequency that is not random, then a source of these particles should be determined and, where possible, rectified. The effect of the particles can be correlated against finished product testing to define what level of particle can be deemed a nuisance.
  • Random: When particles show little or no pattern of occurrence, then a frequency of N of M should be determined–i.e., no more than three particles in any 12 minutes or similar. Again, correlation back to finished product testing should validate the data used in routine monitoring.

The definition of the alert and alarm set points is also examined in the current GMP guidance:

Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded operating procedures should prescribe corrective action.2

The determination of appropriate alerts is that proof of control over the environment, relative to product quality, should be maintained. Therefore, using the limits assigned by the certification data alone may not always be prudent. Rather, limits that better reflect the production environment of each particular facility, filling line, or similar ought to be determined.

The guide is for continuous particle monitoring in Grade A and immediate Grade B areas using an in situ particle counter. This is because the risk of contamination in finished product is very high and the greatest risk factor, the operator, is in close proximity. The operator is not only the greatest risk posed to product but also a random generator of particles. These are not all inert particles; some will be viable, which poses an even greater risk to the finished product. Since we cannot control the risk, we must measure it. If it is in excess of proven acceptable limits, then the system must alert the users. How quickly the facility monitoring system alarm should alert the users is dependent upon the risk (see “Recommended System Setup for a Grade A Zone”).

Analysis of risk can be considered as how resilient the filling operation is to potential contamination events while still able to protect product. If the system is very robust (isolator, restricted access barrier system), then an event has a relatively low risk of contamination. If it is an ampoule line with curtain protection then small deviations could have a greater impact. No answer will fit all applications because all risk is variable. Considerations such as what gowns are used, what undergarments are supplied, air changes per hour rate, number of personnel in room, etc. are all important factors.

Lyophilized product

Product that has been filled aseptically and is to be freeze dried should be maintained within a Grade A environment, from the point of stopper insertion to the freeze dryer. If this is done via a mobile cart, then this mobile environment must be shown to maintain a Grade A environment. When a stopper is not fully inserted, the vial is deemed to be open, and any aseptic vial open to the environment must be maintained within a controlled environment.

Once freeze drying is completed, the stopper is pulled down into the vial or a mechanical pressure is applied to ensure closure, and the stopper is proven to be fully seated via a validated protocol, the vials should be maintained within a Grade A air supply until the cap is in place and crimped. Recall the table from certification: A Grade A environment is essentially an ISO Class 5 environment. Therefore, the quality of air being supplied to the crimping process is better described as being ISO Class 5 quality, from a particle perspective. If the capping activity is performed as an aseptic process, then a Grade A environment must be proven.


Mark Hallworth is pharmaceutical business manager at Particle Measuring Systems in Boulder, CO (www.pmeasuring.com).

References

  1. ISO 14644-1, Cleanrooms and associated controlled environments–Part 1: Classification of air cleanliness, 2003.
  2. European Union Good Manufacturing Practice Annex 1, 2008.

Acknowledgment

Lasair® is a registered trademark of Particle Measuring Systems, Inc.


Recommended monitoring/alarming system setup for a Grade A zone

Step 1: Set all values in the facility monitoring system to m3

Step 2: Set the 0.5-μm alarm channels (1 = alert, 3 = alarm) to 1,625 and 3,250 n/m3. (These values are temporary until the real values are discovered from the process.)

Step 3: Set the alarm level 1 (alert 0.5 μm) to react on a frequency of 2:2 events. So two consecutive events will trigger an alert = orange light.

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Step 4: Set the alarm level 3 (alarm 0.5 μm) to react on a frequency of 3:3 events. So three consecutive events will trigger an alarm = red light.

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Step 5: Set the 5.0-μm alarm channels (0 = alert, 2 = alarm) to 71 and 35 n/m3. (These are identical, but we will use a different frequency to determine risk.)

Step 6: Set the alarm level 0 (alert 0.5 μm) to react on a frequency of 2:2 events. So two consecutive events will trigger an alert = orange light.

Step 7: Set the alarm level 2 (alarm 5.0 μm) to react on a frequency of 3:10 events. So three consecutive events will trigger an alarm = red light.

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This rationale allows technicians to respond quickly to 0.5-μm events but not be alerted for nuisances

I’m thrilled to formally announce the return of the CleanRooms USA Conference & Exhibition After a two-year hiatus, CleanRooms USA will return to Boston, MA on May 12

Compiled by Jason Andrukaitis and Carrie Meadows

We often focus on the importance of keeping products contamination-free, but protecting workers from the risk of contamination by products and keeping them safe while performing tasks is an equally important goal in the cleanroom. This month, we bring you a selection of personal safety gear specifically designed to ensure that worker safety is maintained at all times.

Neoprene single-use gloves

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Powder-free NeoTouch® gloves from Ansell are the first neoprene single-use gloves designed for industrial applications. A comfortable alternative to latex, NeoTouch gloves are suitable for workers with Type I allergies and are highly resistant to acids, bases, and alcohols. According to Ansell, the gloves offer excellent flexibility and elongation qualities and provide a level of comfort similar to latex and superior to other synthetic products. The gloves are more puncture-resistant than latex gloves and assure good chemical resistance, although they are not recommended for extended chemical protection. NeoTouch gloves include textured fingertips for wet and dry applications, with a polyurethane inner coating to assure easy donning. A beaded cuff promotes a secure hold, with the gloves’ green color making them easy to identify.

Ansell
Red Bank, NJ
www.ansellpro.com

Flame-resistant clothing for electrical protection

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More than 2,000 people are admitted to hospitals every year due to electrical arc flash and arc blast injuries. Protective apparel may be all that stands between an electrical maintenance worker and severe injury or even death. Such apparel has long been available for general industry, but the challenge has been how to marry the need to protect workers and protect controlled environments. ARAMARK Cleanroom Services now offers flame-resistant clothing systems compliant with NFPA 70E hazard risk category 2. The company also offers more than a dozen styles of voltage rated gloves, face shields, and insulated tools designed to protect workers from electrical arc flash dangers. The sales staff is ready to work with safety professionals as customers choose the arc flash protection that best suits their needs from among a variety of styles and options. For more information, call ARAMARK Cleanroom Services at 866-838-7498.

ARAMARK Cleanroom Services
Downers Grove, IL
www.aramark-uniforms.com

Apparel for controlled environments

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Connecticut Clean Room Corp. offers a variety of DuPont™ protective apparel for all environments and classifications ranging from industrial to sterile environments. If industry standards call for sterility and/or cleanliness in pharmaceutical, biotechnology, electronics, or medical device environments, DuPont™ limited-use apparel lines could be just the appropriate contamination control solution. Some of the products offered include DuPont Tyvek® IsoClean™, DuPont™ Suprel® LS, DuPont™ ProClean®, as well as shoe covers, boot covers, and other accessories. Choose from (CS) Clean and Sterile–clean-processed, individually packaged, and sterilized by gamma irradiation; (OS) Sterile–individually packaged and sterilized by gamma irradiation; (OC) Clean–clean-processed, individually packaged; (OO or OB) Bulk packaged; or (PI)–Individually packaged in cleanroom bags. To receive a catalog or for information call 860-589-0049 and ask the Customer Care Team for more details.

Connecticut Clean Room Corp.
Bristol, CT
www.ctcleanroom.com

Protective garments, products

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The goal of DuPont Controlled Environments is to provide high-performance solutions for today’s demanding controlled environments. Combining its rich heritage of scientific innovation and material, garment and manufacturing expertise, DuPont Controlled Environments products are specially engineered to enhance productivity in today’s demanding biotechnology, pharmaceutical, medical device manufacturing and electronics cleanroom environments. The company offers a wide range of protective garments and products, including DuPont™ Tyvek® IsoClean™ garments, and DuPont Gripper™ shoe and boot covers with superior coefficient of friction properties. In addition, DuPont Controlled Environments Specialists are industry experts who can help you with your site assessment and a variety of contamination control issues.

DuPont Controlled Environments
Wilmington, DE
www.personalprotection.dupont.com

Safety goggle design services

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Fabrico offers in-house design capabilities that enable custom safety goggle designs while maximizing cost-effectiveness and production efficiency. The company converts a wide variety of materials, including adhesives, foams, rubbers, and laminates from leading materials suppliers to create goggle components such as lenses, lens assemblies, and lens covers. Materials include clear plastic and foam pieces that are cut using precision die-cutting or high-powered water-jet cutting, adhesives that are laminated to other materials, and clear flexible materials that are custom die-cut. Fabrico has also helped create designs for tear-away lens covers that protect goggle lenses from becoming scratched or dirty during use.

Fabrico
Kennesaw, GA
www.fabrico.com

Polypropylene coveralls

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Guardline’s new Sureguard disposable coveralls are manufactured from polypropylene with a polyethylene laminate, affording high levels of cleanliness and tensile strength. Water vapor transmission rates exceed those of other disposables, giving excellent comfort and breathability. CE marked to 5 and 6, Sureguard provides a low cost option without sacrificing quality.

Guardline Technology Ltd.
Thetford, Norfolk, UK
www.theguardlinegroup.com

Tyvek® apparel

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High-Tech Conversions, Inc. introduces cleanroom apparel made with Tyvek®, a unique material made of a spunbond olefin which is a product of the polymerization of propylene and ethylene gases. For the products to be of use as fibers, polymerization must be carried out under controlled conditions with special catalysts that give chains with few branches. Olefin fibers are characterized by their resistance to moisture and chemicals. All apparel is Class 10 cleaned and sterile.

High-Tech Conversions, Inc.
East Windsor, CT
www.high-techconversions.com

Stretch coveralls and color-coded respirators

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Kimberly-Clark Professional has announced its new KleenGuard A30 stretch coverall, which combines comfort and dry particulate protection with a new design that features stretch panels under the arms and across the back, providing increased range of motion, quality protection, and better fit at a competitive price. The company’s iFlex stretch technology enables the coveralls to move and stretch with the wearer. Made with the same stretch material found in Huggies® brand diapers, the patent-pending stretch panel provides the same level of protection as the primary fabric. The A30 coverall is recommended for use in pharmaceutical research; tasks involving fine particle contamination; and for the aerospace, maintenance, and general manufacturing industries. The KleenGuard M10, M20 and M30 particulate respirators are available in NIOSH N95 valved and non-valved (blue strap), R95 valved (yellow strap), P95 valved and N99 valved (orange strap).

Kimberly-Clark Professional
Roswell, GA
www.kcprofessional.com

Specialty gloves include electrical shock protection

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PIP Technical offers a wide range of gloves used in the critical environment industry. Cleanteam® products range from ESD gloves, disposable nitrile, latex, pure vinyl, co-polymer vinyl gloves, nylon and polyester glove liners, cotton lisle and nylon inspection gloves and nylon knit with polyurethane coating. Rubber insulating gloves have always been one of the most important components of PPE for electrical and industrial workers. Novax gloves exceed all requirements of ASTMD120, ensuring compliance with OSHA regulations and satisfying NFPA70E requirements for protection against electrical shock hazards. Natural rubber construction offers excellent dielectric properties combined with flexibility, strength, and durability. A contoured shape reduces hand fatigue, and the rolled cuff provides increased durability during donning and doffing. For more information please call 800-262-5755.

PIP Technical
Guilderland Center, NY
www.pipusa.com

Limited-use protective gowns

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PolyCo is pleased to announce the introduction of VR™ protective gowns. For use in contamination control and cleanroom environments, the gowns are lightweight and provide employees with impervious protection against chemical and biological contaminants. The apparel has been clinically tested to offer superior resistance to chemicals such as nitric, sulfuric, hydrochloric, and hydrofluoric acids. For cleanroom applications, all VR products are processed, folded, and individually packaged. Independent tests of VR have demonstrated that VR meets Class 100 cleanroom specifications. Engineered to provide affordable limited-use protection, VR has been developed by PolyCo to replace conventional protective garments made out of vinyl and other traditional materials intended to safeguard cleanroom employees from potential chemical or biohazard contamination. The gowns feature a full frontal coverage design, seamless edges eliminating entrapment of particles or chemicals, and thumb loops providing uniform transition between sleeve and glove.

PolyConversions, Inc.
Rantoul, IL
www.PolyCoUSA.com

Protective barrier fabrics

Polymer Group, Inc. unveil an expanded family of protective apparel fabrics and converted garments that deliver enhanced safety and greater comfort for workers. The new lineup includes coated and laminated fabrics with high barrier properties and finishes to protect workers against fire, dangerous air particulates, toxic chemicals, blood transfer, and other hazards. These breathable and durable materials are resistant to toxic chemicals and surface resistivity and meet ASTM, anti-static, and other requirements. The company’s product lineup includes Pentamax® with five layers of polypropylene, PolyBreathe® composite fabric offering a barrier for extremely fine and normal dry particulate and liquid spray, Poly-Safe® designed for splash protection against a variety of toxic and harmful chemicals, and Poly-Bond® designed for general-use applications.

Polymer Group, Inc.
Charlotte, NC
www.polymergroupinc.com

Disposable eye and full-face shields

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Qosina introduces face and eye protection to its expanded selection of disposable lab wear. Both the eye shields and full-face shields can be worn over surgical masks or eyeglasses. The downward angle of the shield protects wearer from splashes and sprays. Top and bottom openings prevent fogging and allow for unobstructed peripheral vision. The full-face and eye shields have a distortion-free optical grade lens and are sold with a removable protective film to prevent scratches. Lightweight polypropylene frames are offered in a choice of black, white, pink, yellow, or red. Eye frames have a wide band for a comfortable fit, even over eyeglasses. An additional frame style has a polypropylene clip and adjustable evoprene tubing, providing a secure fit. The frames are available with polycarbonate shields in eye (goggle) or full-face styles.

Qosina Corp.
Edgewood, NY
www.qosina.com

Filtering respiration mask

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Tronex’s N95 filtering respiration masks are specially designed to help guard against dangerous viral, bacterial, and other particulate contaminants. The Tronex N95 particulate respirator conforms to NIOSH 42CFR Part 84 Standard as N95 class, 95% effective against particulate aerosols free of oil. It effectively protects against the transmission of airborne pathogens such as avian influenza, tuberculosis (TB), and sub-micron particulates. While the mask efficiently shields against particle inhalation and exhalation, it does not hinder breathing or speaking. The one-size-fits-all mask with latex-free head strap, PP smooth lining, and contour fit is designed for extended wear, maximizing user comfort. For more information, please call 973-335-2888 or e-mail [email protected].

Tronex Co.
Parsippany, NJ
www.tronex.com

Flame-resistant coveralls

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Universal Overall Co. has expanded its product offerings to include a full line of cleanroom apparel made with Burlington C3 and Integrity 1800. The company will also feature flame-resistant coveralls, hoods, and shoe covers featuring Filament Nomex® fabric with carbon grid for ESD. The apparel meets NFPA Standard ATPV 5.3 Cal/cm2 and provides multi-layer protection, two-way Nomex taped brass zippers, no pockets or pass-through openings, concealed snaps at waist and collar, and full concealed elastic cuffs.

Universal Overall Co.
Chicago, IL
www.universaloverall.com

Standard and customized protective apparel

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Vestilab Clean Room Control has been manufacturing cleanroom garments for 25 years. The company uses high-quality fabrics and accessories according to IEST-RP-CC003.3. Depending on the features of the working area or final product, technical fabrics are used to protect not only the quality of the final article but also the user from hazardous products (hormones, vaccines, cytostatics, chemical agents) or heat sources. Vestilab has a wide range of both standard and customized garments to meet all the customer’s established requirements. Garments are supplied with bar codes or microchips in order to allow their traceability during the garments’ lifetime.

Vestilab, S.A. CRC
Barcelona, Spain
www.vestilab.com

Traceable anti-static jumpsuit

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X&Y introduces a new jumpsuit for contamination control applications including those in the electronics, microelectronics, semiconductor, LCD, pharmaceutical, biotech, constructions, optoelectronic, and aerospace industries. The anti-static garments are made with a high-quality, long-fiber polyester material that allows cleanliness, filtration, comfort, durability, and easy dressing. Imported conductive fibers ensure the anti-static performance of the products. The jumpsuits are cleanroom Class 10 laundered. A barcode tracing system is used to track the status of the garments. Advanced test instruments and methods are combined with a strict quality control system to ensure the high quality of each finished product.

X&Y International Industrial Co., Ltd.
Shenzhen, China
www.xing-ye.com