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Tag Archives: Clean Rooms
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The best sanitation programs are designed along with the product and aggressively implemented early in the manufacturing process.
By Sarah Fister Gale
The cleaning, disinfecting, and sanitization of a clean manufacturing environment determine the safety and effectiveness of the end product. These steps make the difference between a pristine product and a sullied reputation, yet product designers across industries tend to spend little up-front time designing and prioritizing sanitation programs in the product development process–and that can lead to costly delays in getting products to market and surprising sanitation issues down the production line.
Every industry has different procedures to ensure the cleanliness of its products and the processing environment based on the risks to the end user. And while a manufacturer of raw food products that will be cooked by the consumer may have more contamination leeway than those making injectable pharmaceutical products or implantable medical devices, they all have the same agenda: to produce consumable products free from bacteria and other contaminants that could ultimately harm the user and the brand.
The most successful manufacturers see the sanitization program as an integral part of the product design process, says Lisa Foster, vice president of Steripro, the consulting and laboratory services division of Sterigenics International, a contract sterilization organization in Corona, CA. “People think cleaning, disinfecting, and sterilization are the last act so they can be left till the end, but that’s a huge mistake, whether you are in pharmaceuticals, medical devices, or food,” she says. “You need to look at these steps up front in the product design process long before you get to manufacturing.”
She advises clients to consider attributes of cleaning, disinfecting, and terminal sterilization during product design and assess those goals against all materials, ingredients, and process steps in the product. She points out that it’s easy to select materials that won’t be compatible with your sanitization or sterilization choices–Teflon, for example, can’t be gamma sterilized. “If you want a Teflon stopper or a pre-filled syringe, the product can’t be closed prior to sterilization.”
If a material you want or need conflicts with your sanitization goals, you can make decisions during the design phase to address the problem before the manufacturing environment is established. In the case of the Teflon stopper, you could opt to pre-sterilize the components separately using an aseptic filling step followed by terminal sterilization of the outside barrier, or choose another material for your stopper.
“You need to determine what methods will work and design the product around that,” Foster says. “When you develop a product with effective sterilization processes from the beginning, you will save a lot of time and money during production phases.”
A clean education
Once a product is designed and the sanitization program is established, the only way to ensure it remains effective is through training. “Good sanitization is all about education, and reminding people of the little things that they may know to do but can forget when they are under pressure to get the job done,” says Chris Celusta, manager of food processing sanitization for Spartan Chemical, a Maumee, OH-based manufacturer of chemical specialty maintenance products and industrial degreasers. “But don’t inflict paralysis by analysis. Sanitation crew training has got to be simple, to the point, and ongoing.”
Celusta points out that while senior management may be committed to a clean environment, sanitation crews are often less tied into the corporate goals and strategies. They often work in low-level positions with high turnover, despite the fact that they serve a critical role in the production process. To ensure they are as committed to sanitization goals as the rest of the team, sanitation training must also incorporate the reasons behind the cleaning program. “You can’t just tell your cleaning crew what to do; you have to explain why they are doing each step and what the result will be if they skimp on or skip something,” Celusta says. “Otherwise, crews may make assumptions that can result in problems.”
Those problems are not just issues of yield or delays. When sanitation crews skip steps dangerous bacteria, including E. coli and Listeria, can gain a foothold in processing facilities and lead to outbreaks of foodborne illnesses. Each year an estimated 76 million people contract a foodborne illness and 5,000 die because of food safety issues from bacteria that can be prevented with proper sanitation.
 Figure 2. The Cobalt 60 radioisotope is used for gamma sterilization in the underwater chamber. Photo courtesy of Steripro/Sterigenics. |
Those outbreaks don’t just hurt one company or brand. Every time the public learns of a food recall it loses faith in the entire food production industry, says Celusta, who notes that consumer confidence in food safety is at an all-time low. “When you have a national recall, it draws a lot of attention to sanitation strategies throughout the food industry,” he says. “Company owners and consumers want to know you are doing what you are supposed to be doing, and that every ingredient in a product comes from a reputable source.”
Ready-to-eat products, such as lunch meat or fresh-cut produce, pose the greatest risks because they don’t involve a cooking, cleaning, or other “kill step” by the consumer. Whatever goes out the door on the product will be ingested.
“The
Designs can only be successful if the proper actions are taken to maintain cleanliness levels
By Thomas E. Hansz, AIA, Facility Planning & Resources, Inc.
Last month’s article on ISO 5 cleanrooms discussed the importance of establishing and maintaining the appropriate level of contamination control in a cleanroom. This holds true of cleanroom design at any level of cleanliness, and requires a close relationship between the cleanroom design process and the development of operational protocols. This is critical for whatever industry the cleanroom is intended to support.
Sticking to a cleanliness program
As cleanroom consultants, we spend a considerable amount of time in our clients’ facilities, documenting existing conditions and observ-ing operations. On one such opportunity, we were asked to correct a cleanroom design that was producing unacceptably high particle counts in an ISO 7 level medical device packaging line. During our investi-gation, we discovered that the cleanroom was properly designed and adequately equipped; however, one day standing outside the cleanroom, we soon discovered the real problem with the client’s contamination control. We watched as a cleanroom technician walked out of the gown room, proceeded down the hall to a vending machine, purchased a candy bar, and returned to the cleanroom, fully gowned. As we later interviewed the cleanroom staff, it was plain to see that operational protocols existed but were never enforced.
 Figure 1. Proper gowning is the first step toward maintaining cleanroom protocols. Photo courtesy of Facility Planning & Resources, Inc. |
Contrast this to some operators who run what I will describe as “very basic” cleanrooms, yet achieve exceptionally low particle counts well below the cleanliness levels for which they were designed. In these cases, each cleanroom is operated in strict accordance to the established protocols, and they undergo daily vacuuming and cleaning. All cleanroom employees are focused on their work responsibilities, which includes maintaining the cleanliness level of their work environment.
One client has given the person in charge of daily cleanroom maintenance the authority to remove anyone from the cleanroom who does not follow the protocols or is not properly gowned. Dubbed the “Cleanroom Marshal,” he related with pride the time he stopped the president of the company and made him return to the gown room to put on a face mask, which was required for all persons with facial hair. It is no surprise to see that the facility’s production reject rates were so very low. Attention to cleanliness positively affects the bottom line.
Nanotechnology and industry applications
As discoveries in nanotechnology are applied to more and more industries and academic research, ISO 7 level cleanrooms (as well as ISO 8 and ISO 9) are becoming more prevalent. Once found only in integrated circuit assembly and test facilities and in pharmaceutical facilities, ISO 7 cleanrooms are commonplace throughout industrial sectors such as biomedical, biotechnology, medical device, automotive, advanced materials, metallurgical, and optical devices. Universities and colleges are also adding ISO 7 cleanrooms to support research programs in chemistry, biology, biochemistry, and biomedical applications.
Cleanroom entry and exit
Two of the more common mistakes in ISO 7 cleanrooms are the under-sizing of the gown room and the absence of supporting intermediate clean spaces. Cleanroom personnel should enter through a gown room that affords sufficient space for individuals to enter, gown up, and prepare to enter the cleanroom concurrently with individuals leaving and de-gowning. Airlocks should be placed between the gown room and the cleanroom as a final measure for eliminating particles from entering the controlled space. The air shower is characterized by a high velocity (6,000 fpm+) air stream scouring the garment of the person passing through into the cleanroom. In high traffic situations, an air shower tunnel may be used to accommodate a stream of people rather than a one-at-a-time air shower. When leaving the cleanroom, a separate door into the gown room is required because the air lock should only be used for entering the cleanroom.
Supporting intermediate spaces include pass-throughs and wipe-down rooms. Pass-throughs are installed in the wall separating the cleanroom from a non-controlled space, allowing materials, chemicals, and other items to enter the cleanroom without going through the gown room. Similarly, separate pass-throughs are required for finished work and wastes leaving the cleanroom. Pass-throughs have interlocking doors to prevent both doors from being opened at the same time. Airlock can vary in size from very small units–12 inches in height, width, and depth–to those large enough to accommodate lab carts. Special protocols should be developed as to the preparation and containment of items entering through a pass-through.
 Figure 2. Flexible cleanrooms require designing in balanced airflow patterns. Photo courtesy of Facility Planning & Resources, Inc. |
Wipe-down rooms for equipment and materials to be unpacked and wiped clean are necessary where these items frequently enter the cleanroom. Although such spaces may seem like a luxury, their use can often prevent the cleanroom from becoming contaminated and requiring a thorough cleaning and reclassification. The principle at work is what we described last month as “islands of cleanliness.” Regardless of the cleanliness level, if the principle is followed and maintained, the chances of successful contamination control are very high.
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Let’s look at some of the basic physical components of ISO 7 cleanrooms: walls, ceilings, floors, airflow structures, and lighting.
Cleanroom wall and ceiling components
Class 10,000 cleanroom wall systems using vinyl-covered gypsum wallboard on steel studs have been around for years and continue to be quite popular due to their relatively low cost. However, due to the composition of the panel itself, they are not recommended for installations that require reconfiguration or frequent change-out of equipment or utilities. Many of the manufacturers of such wall systems proudly refer to the fact that their panels conform to Federal Standard 209 D, which has been superseded twice in the past 20 years.
In ISO 5 level and above cleanrooms, powder coated, aluminum honeycomb wall systems have been an industry standard for decades; they are anti-static, they do not shed particles, and they do not outgas. They offer other advantages as well: They are non-combustible, lightweight, and easily relocatable. Where these considerations are important, they make excellent wall systems for ISO 7 cleanrooms.
Life science and pharmaceutical operations usually require wall systems that are thoroughly washed on a regular basis. The finished surface must withstand cleaning and sanitization with various chemicals that resist fungal and microbial growth. Another consideration for life science and pharmaceutical wall systems is to have a curved base where the wall meets the floor. This follows current Good Manufacturing Practice requirements for maintaining aseptic and/or sterile environmental conditions.
For ISO 7 cleanrooms, composite wall systems are available in a variety of options. Wall panels can have interior cores of aluminum honeycomb, paper honeycomb, expanded polystyrene, or isocyanurate insulation. In addition to the powder coated aluminum surfaces, many cleanroom wall manufacturers also offer high pressure laminates, melamine, vinyl, stainless steel, and PVC. It is recommended that the cleanroom ceiling panels be of the same finish as the wall panels. Either the ceiling panel or the ceiling suspension system needs to be capable of supporting the fire sprinkler system. With so many options, it is important to select a wall and ceiling system that supports the work, as well as complying with federal regulations and other requirements.
Windows are another consideration for the cleanroom wall system. Windows should be flush to the wall on the clean side to prevent accumulation of particles. Designs are available for flush windows on both sides of the wall, a particularly useful feature for windows between adjacent clean spaces. Whether for a corporate, institutional, or academic cleanroom, window placement is important for visual safety, permitting supervision from the outside. Windows are also important for supporting marketing tours that invariably include looking into the cleanroom.
Floor surfaces
Floors on grade are frequently covered with a high-solids epoxy finish applied to an appropriately prepared concrete surface. Vinyl tiles and vinyl sheeting, with standard, static dissipative, or conductive characteristics, are also used, depending on the application. Whether to use a raised floor or not for your cleanroom depends upon factors such as the volume of recirculating airflow, the need for under-floor utilities and/or exhausts, and the criticality of regular cleaning.
Airflow
The table of airflow guidelines (Table 1) relates the cleanliness class to a range of air change rates that increase as the ISO cleanliness class becomes more stringent. The table presents ranges of values to underline the notion that this is not an exact science. The final selection of air changes per hour is based on the process to be protected, the number of people working in the cleanroom, the activity and movement of those people, and the ratio of acceptable yield of finished work.
For ISO 7 cleanrooms, notice that the two variables in the chart are the airflow velocity and the number of air changes per hour. Other factors that need to be taken into account are the uniformity of the airflow pattern within the room and the configuration of the room itself. So to successfully provide the ISO 7 level of cleanliness, the HEPA filter coverage can vary from the 20 percent recommendation. It is important to remember that the following rates are recommendations, not hard and fast rules. We have been very successful in building
ISO 7 cleanrooms with varying percentages of filter coverage.
 FIgure 3. Floor air returns should be strategically placed near major pieces of equipment. Photo courtesy of Facility Planning & Resources, Inc. |
It should be mentioned that the design of the air pattern relies on careful filter placement in the ceiling as well as careful air return placement at the cleanroom floor. It is important that the cleanroom designer fully understand the process within the cleanroom to ensure that an optimum design is created at the lowest cost.
Temperature
The temperature to be maintained in the cleanroom is driven by either comfort or by the process. Comfort in an ISO 7 cleanroom can generally be met by maintaining a temperature of 72
How to ensure that quality data is being obtained from optical particle counters (OPCs) in liquid applications
By Roger Carlone, Particle Measuring Systems
Ensuring that your liquid optical particle counter (OPC) is operating within its designed specification is critical to obtaining quality data. As data from OPCs becomes increasingly important to maintaining process control, it becomes more critical than ever for users to have confidence in the data being generated. OPC data is frequently used in qualifying process improvements, in control during chemical manufacturing, and in quality control for production of complex parts. It is not uncommon for users to question the results from their particle counters. Discussed in this article are common misunderstandings and other performance issues that would lead one to question their OPCs.
Introduction
Users can take several easy steps to ensure that quality data is collected. All OPCs have defined and easily controlled specifications. These specifications are flow rate, background scatter, and concentration limit. Also important is the particle size distribution (PSD). Unless all of these parameters are correct, the data should be considered suspect. Even if one parameter is incorrect, the data quality has been compromised. This article summarizes these parameters and their effects on each other, and it also covers ultimately ensuring that quality data is achieved when analyzing ambient particle distributions in process chemicals and deionized (DI) water.
Normal particle distributions
Thirty years of particle counting experience shows that most ambient particle distributions in continuously filtered liquid systems follow a D-3 distribution (D = diameter) on total cumulative counts. Figure 1 shows a normal particle distribution. In extremely clean DI water systems, the distribution can be steeper (D-4), and in dirty systems, the distribution can be flatter (D-2). It is equally important that whatever the distribution is, it remains consistent from sample to sample.
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When analyzing particle data, it is essential to ensure that you have a normal particle distribution. If not, it should immediately alert the user to a potential problem. Things that can lead to abnormal distributions or poor data are incorrect flow rate, excessive background scatter, and exceeding the OPC’s upper concentration limit. In addition, real particle events such as pump or valve failures, o-ring problems, damaged tubing, or other process upsets can cause abnormal particle distributions. This is why it is critical to ensure that quality OPC data is collected. Otherwise, one would not be able to identify a real particle excursion from a poorly performing OPC.
Flow rate
All OPCs have a flow rate specification. The specification is most
commonly listed as the set flow rate plus or minus a certain percentage; for example, 50 ml/min
By George Miller
Construction spending and cleanroom space growth are in line with past several years, driven by migration to 300-mm technology
Boasting 12 percent of the world’s integrated-circuit fabrication capacity, and nearly one-third of the world production of power devices, Europe accounted for some $6.6 billion in semiconductor equipment and materials spending in 2007, according to the trade group SEMI.
For the traditional semiconductor IC fabs, construction spending in Europe was expected to exceed $700 million last year, rising from $450 million in 2006. In terms of fabs purchasing equipment, companies are expected to spend about $2.5 billion, a decline from the more than $3 billion of 2006. SEMI expects spending to increase by about 9 percent in 2008.
General trends in the semiconductor industry are mirrored in the contamination control market, according to Risto Puhakka, president at market research company VLSI Research in Santa Clara, CA.
“The number one [European semi-conductor equipment] supplier is ASML Holding NV (Veldhoven, Netherlands), and its outlook is very optimistic for 2008, based on a strong backlog,” says Puhakka. “The rest of European semiconductor makers will follow industry expectations more closely. We expect them to be slightly down.”
Positive effect
With ASML comprising such a large part of the European equipment market, “it may pull all of Europe onto the positive side,” Puhakka says.
The state of the economy is the biggest concern. “So far we haven’t seen electronics demand slowing in a considerable way,” he says. Yet, “[the economy is] the overarching problem.”
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Market intelligence concern iSuppli Corp. (El Segundo, CA) agrees, and in late December cut its 2008 revenue growth forecast for the global semiconductor industry to 7.5 percent from 9.3 percent, based on rising energy costs and expectations of a U.S. economic slowdown.
Market and fab diversity
Europe is home to more than 278 production and R&D fabs that manufacture various integrated circuits, microelectromechanical systems (MEMS), power devices, compound semiconductors, and innovative packages, according to SEMI. Included in this population are several 300-mm wafer fabs, and several fabs boasting sub-90-nm technology.
Europe is also home to three world-class semiconductor R&D centers of excellence: Inter-university Micro Electronics Center (IMEC) in Belgium, Laboratory of Electronics and Information Technology (LETI) in France, and Fraunhofer Institute in Germany. In light of changing markets and emerging opportunities, several European device companies and equipment companies have increased their involvement in the area of MEMS and photovoltaics (PV) manufacturing.
Regarding cleanrooms in Europe, the outlook is for growth that is in line with that of the last few years. A major driver is the migration to 300-mm processing technology.
Recent migration
Among the more recent of these migrations is dynamic RAM supplier Qimonda AG, which announced in late December that it would increase to approximately 90 percent its share of 300-mm capacity and reduce capacities at its 200-mm manufacturing facilities worldwide.
The company is discontinuing its contract manufacturing of 200-mm Qimonda products by Infineon Dresden. The last wafers for Qimonda were expected to enter production in February 2008, the company says. Qimonda’s cornerstone activities in Dresden moving forward will be its 300-mm manufacturing and research and development activities.
200-mm wind-down
Similarly, at its Richmond, VA site in the U.S., the number of 200-mm wafer starts will be reduced by about 15 percent, in the context of switching capacities from 110-nm to 80-nm technology. The remaining 200-mm capacity will continue to be used for manufacturing legacy products.
In Asia, contract manufacturing of 200-mm capacity by Qimonda partners Winbond and SMIC were discontinued by the end of 2007.
Space additions
Market researcher McIlvaine Co. expects Europe to see the addition of more than 3 million square feet of cleanroom space in 2008, bringing the total cleanroom space in use to nearly 24 million square feet (see Table 1).
Memory glut
From a global perspective, memory–especially dynamic RAM–is in a state of oversupply. According to Puhakka of VLSI Research, “There’s no profitability. Suppliers can’t invest in more manufacturing capacity.”
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“Most predictions say that in the second half of this year, [the memory oversupply situation] should start to improve,” he added. “We’re more pessimistic. There needs to be [industry] restructuring to limit supply more. It will probably take a full year to work its way through.”
As if on cue, Japanese chip maker Fujitsu announced in late January that it too would join in the restructuring, though it had thus far avoided a recent flurry of process development alliances reshaping the semiconductor industry. The company announced that it would put its LSI business divisions into a new subsidiary and devote its semiconductor technology development center to other purposes. The company will move process development and prototyping equipment from a 200-mm facility in Tokyo, some 300 km south, to a 300-mm production fab in Mie prefecture. It will continue 45-nm logic process development at the Mie fab, where application-specific ICs and other logic products are made.
Global rebalancing
Beyond the semiconductor industry restructuring that’s underway, a broader electronics manufacturing global rebalancing is taking place as well, according to iSuppli. The rebalancing is the result of a shift in executive thinking to total cost of fab ownership, rather than just the cost of labor.
In the early 2000s, manufacturing capacity abruptly shifted from the high-cost regions of North America and Western Europe, to the low-cost nation of mainland China, according to Adam Pick, a principal analyst at iSuppli. However, the second half of this decade is revealing the change in thinking.
Total cost of ownership
The regional diversification by electronics manufacturers can be attributed to other China-centric factors, including a mobile workforce, inflation, taxes, and the rising costs of transportation due to soaring oil prices. According to Pick, in an iSuppli announcement, “The emphasis has greatly shifted to total cost of ownership, which considers managerial resources, organizational structuring, manufacturing competencies, intellectual property, and, of course, logistics.”
He added that recent capacity expansions of electronic manufacturing service providers, original design manufacturers, and OEMs reveal several trends impacting the global electronics manufacturing business.
First is the rising penetration of emerging regional economies, a factor that continues to be critical for many EMS and ODM providers. India’s domestic market has attracted foreign direct investment by such leading providers as Foxconn, Flextronics, and Jabil.
More recently, however, Russia has become a focal point for electronics manufacturers. While television specialist Vestel A.S. has been building its ODM/Own Brand Manufacturing presence in Russia for some time, Foxconn Electronics Inc. in August 2007 announced a $50 million investment in the nation to build data-processing systems for Hewlett-Packard Co.
“The second trend is that proximity to large, local markets with fast-growing product segments appears to be critical to ODMs,” Pick says. This is particularly true for companies that want to establish liquid-crystal display television manufacturing for western European distribution.
Wistron Co. Ltd. and Quanta Computer Inc. recently established capacity in Eastern Europe to build flat-panel sets for OEMs, including Sharp Electronics Corp. and Hewlett-Packard Co. According to Pick, “The ODMs’ local presence in the region helps minimize tariff costs throughout the European Union.”
Big spenders
The largest spenders in terms of European fab construction projects and equipment purchases in the second half of 2007 were AMD and Intel, according to the SEMI Fab Capacity database.
Stuttgart-based M+W Zander was awarded the order to support AMD’s conversion of its semiconductor factory Fab 30 to Fab 38 (The name Fab 38 comes from its existence 38 years after the founding of AMD), while continuing to carry out routine operations at the Dresden facility without interruption. M+W Zander will also be responsible for the hook-up of utility systems to the machinery assets of the new Bump Test building and expansion at Fab 36.
Fab 38 is being created by remodeling Fab 30. Future production at the remodeled fab will be carried out on 300-mm wafers, while Fab 30 currently manufactures microprocessors using 200-mm technology. The conversion will enable Fab 38 to make a substantial contribution to the planned capacity increase at the Dresden site.
Numonyx, the Flash joint venture between Intel and STMicroelectronics, was expected to spend $600 million for upgrades at its Fab 18 facility in Israel (Fab 18 manufactures processors using 0.18-µm technology).
SEMI also says it expects the unoccupied 300-mm fab (M6) in Catania, Italy, to be reactivated under the Numonyx joint venture.
Top fab capacities
In 2007, four companies were responsible for most of the fab capacity in Europe: Infineon, Intel, NXP, and STMicroelectronics. They have a combined capacity of more than 700,000 wafers per month (in 200-mm equivalents), accounting for 41 percent of all European fab capacity, according to SEMI.
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STMicroelectronics NV in January attributed at least part of its success to the rising popularity of integrated digital TV.
iSuppli predicts that global revenues from the DTV chip market will reach $14.2 billion in 2011, rising from $7.1 billion in 2006. The total includes revenues generated from chips on DTV audio/video boards, as well as from other TV components, including I/O circuitry, drivers, audio, and power supplies.
“The growth of the DTV chip market parallels the expansion of the DTV market itself,” says Shyam Nagrani, principal analyst for display electronics at iSuppli. ‘Global DTV shipments will rise to 230 million units by 2011, nearly three times the 77.4 million in 2006.”
STMicroelectronics claimed it had increased MPEG-2 market share in 2007, shipping 10 million decoders for iDTV. iSuppli pegged the European market for iDTV at 12 million sets.
Country comparisons
Comparing fab capacities within Europe, the powerhouses are Germany, France, and Ireland. Dresden is considered the hot spot, hosting Infineon, Qimonda, and AMD. Ireland is lead by Intel, which maintains two 12-inch fabs and one 8-inch fab in Lexlip. In France, STMicroelectronics, Altis, Atmel, and Freescale are the leading fabs providing most of the capacity. STMicroelectronics is also the leader in Italy, followed by Micron and Numonyx.
MEMS and solar markets
SEMI expects the global solar photovoltaic market, which currently exceeds $7 billion, to reach more than $16 billion in 2012. Some 200 companies globally produce manufacturing equipment for the photovoltaic market and nearly half are headquartered in Europe. Many semiconductor suppliers are diversifying into photovoltaics, according to SEMI. These companies are using their semiconductor experience to build state-of-the-art production systems and facilities to produce cells and modules.
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The MEMS equipment market reached $646 million worldwide in 2006, and SEMI projects growth to $838 million in 2009 and $999 million in 2011. The five-year CAGR forecast for MEMS equipment is 9 percent.
According to the January European Microelectronics Market Study, Europe accounts for 16 percent of MEMS worldwide sales, and Germany has the highest number of MEMS fabs.
European companies continue to diversify and grow in these markets, SEMI says. Faced with tough competition from other regions, Europe is pursuing its drive to 300-mm technology. Its strong R&D infrastructure and diversity of chip markets addressed will likely continue to yield additional revenues and market share, despite any pending economic slowdown.
By Bruce Flickinger
Solar energy companies are ready for their day in the sun
Companies operating in the solar energy/photovoltaics (PV) marketplace are facing what is often called a good problem to have: how to meet growing demand for its products. The call from public and private sectors for sun-derived power has been increasing steadily for decades, and while worldwide capacity is there to meet it, the challenge is cost effectively putting it to use. Solar energy companies are poised to address the issue, moving from under the shadow of semiconductor manufacturing to flourish on their own and bring the necessary advances in materials and manufacturing technology.
The numbers attest to accelerating activity. According to Solarbuzz, a solar energy market research firm with offices in Aachen, Germany, the global solar industry spent some $2.8 billion on plant and equipment in 2006, adding 548 MW to bring worldwide capacity to 2,204 MW, a 33 percent jump from the previous year. Solar sales (equipment and installations) reached $10.6 billion in 2006 and will likely grow to somewhere between $18 billion and $31 billion by 2011.
A majority of this growth is occurring in Europe, and Germany is its heartbeat. Germany’s grid-connect PV market grew 16 percent to 960 MW in 2006 and now accounts for 55 percent of the world market. Spain and the U.S. were the strongest growth performers last year, with the Spanish market up more than 200 percent in 2006 and the U.S. market up 33 percent.
Industry wide, “solar markets, manufacturing, and equipment are largely located in Germany,” says Charles Gay, vice president and general manager of the Applied Materials Solar Business Group, Santa Clara, CA. “It’s the hotbed of solar activity right now.” About half of Applied Materials’ solar employees are based in Europe, with about 40 percent of these in Germany.
Like Applied Materials, many companies, ranging from small R&D consortia to the world’s largest materials and technology suppliers, are committing themselves to solar energy development. Their collective goal is to make solar cells more efficient and more durable, while reducing manufacturing costs by 40 to 50 percent over the next three years–a critical touchstone cited by several stakeholders.
Manufacturing matures
While solar power has a lot to offer in terms of being a reliable, renewable source of energy, it is currently somewhat cost prohibitive to generate. Current PV technology is based primarily on borrowed technology and off-specification material from semiconductor manufacturing and has been characterized by incremental innovation. The industry clearly is in its formative years, but observers say the future will be characterized by more radical innovations, particularly in manufacturing and equipment, along with higher quality silicon or the use of alternate materials that will bring the price-per-watt to sustainable levels.
To achieve this, all stages of advanced PV product development are being targeted for improvement, from material and device concepts to system development and manufacturing. Noah Kaye, with the Solar Energy Industries Association (SEIA; Washington, DC), points to two key areas: the “need to identify fabrication processes to improve material properties during manufacture, and improved diagnostic techniques to identify properties and quality of solar cells materials during manufacturing.”
Another requirement is true in-line, high-throughput processing of PV films and modules. Current lines involve mechanical tool connections and are not very flexible; advanced manufacturing techniques, such as smart automation, computer integrated manufacturing, manufacturing execution systems (MES), maintenance schedules, logistics, and sophisticated work in process (WIP), are beginning to be adopted.
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M+W Zander FE (Stuttgart, Germany) is considered in front of the curve in designing large-scale PV manufacturing facilities, and expects to have one manufacturer’s silicon-based facility onstream next year capable of producing 1 GWp. “We call this type of an integrated gigawatt factory a Gigafab,” says managing director Robert Gattereder. “It includes wafering, cell manufacturing, and module assembly, and it could be realized with three parallel production lines. In the thin-film sector a Gigafab will be realized around about 2011, with four parallel production lines.”
The key challenge, Gattereder says, is improving manufacturing cost efficiency, particularly by reducing the number of pieces of equipment, which reduces the manufacturing area and allows more efficient distribution of supply and disposal systems. Large-scale manufacturing also means “greener” manufacturing, with trigeneration plants “that provide all their own energy requirements in terms of electricity, steam, and hot and chilled water,” he says. Overall, “about 25 percent of initial investment costs could be saved by large-scale manufacturing.”
In terms of critical controls, solar cell/module manufacturing generally is much more forgiving than integrated circuits, although environmental contaminants will be a larger concern as material and tool tolerances tighten. For now, ambient conditions in a solar cell fabrication facility are similar to those found in a typical office space.
Two potential sources of contamination that manufacturers must control, however, are the water and detergents used to clean the glass surfaces and the purity of feedstock gases used for deposition on the surfaces. “The automation of glass handling and cleaning are leveraging considerations in optimizing how a factory works,” Gay says.
Another benefit of automated, larger scale manufacturing is the ability to produce integrated large-area modules that contain the necessary wiring and circuitry; smaller panels, conversely, need to be wired together in the field. “The market is hungry for these larger area modules, both for commercial buildings and solar farms,” Gay of Applied Materials says. “There are significant cost savings in installing larger modules because there is less wiring in the field and less mounting hardware involved in assembling the panel.”
 Figure 2. PV wafer fabrication line developed by M+W Zander in Stuttgart, Germany. Photo courtesy of M+W Zander. |
Applied Materials is now able to apply a thin film to a glass substrate about the size of a garage door. Five or six years ago, Gay says, the largest panel the industry was able to produce was about 10 square feet. “The size of the manufacturing lines needed in solar has risen to a scale today such that each new line has to have a throughput of 50 MW a year,” he says.
This is accomplished through a cost-of-production metric driven by the interplay of decreasing cell thickness and increasing panel surface area.
Optimizing efficiency
PV-based solar cells convert sunlight directly into electricity. They are made of semiconductor materials, notably silicon. When sunlight is absorbed by these materials, the solar energy knocks electrons loose from their atoms, allowing the electrons to flow through the material to produce electricity. The process of converting light to electricity is called the photovoltaic effect.
Industry averages for cell efficiency–how well the cells convert light to energy–continue to increase steadily at tenths of percentage points, according to SEIA, with some significant outliers and breakthroughs being made above the average. The average for crystalline silicon-based solar products is about 15 percent; the highest efficiency panel on the market, about 22 percent, comes from a company called SunPower, headquartered in San Jose, CA, Kaye says.
Kaye adds that researchers at the University of Delaware are working under a grant from DARPA to manufacture a 50 percent-efficient cell. They recently reached the 42.8 percent mark using a lateral optical concentrating system that splits solar light into high, medium, and low energy bins, and directs them onto cells of various light-sensitive materials to cover the solar spectrum.
Still, Gay and others say that, while solar efficiency obviously is a concern, the overriding issue by far is cost-per-watt.
“Efficiency is a good metric, but not the first-order metric,” Gay says. “In developing countries, where a solar panel might provide electricity for an entire home, users can work with larger, less efficient panels, but in countries like Germany, for example, you want to put as many watts as possible on the roof.”
“At the end of the day, it’s about the price of the panel: Users are looking for the best return on investment for the total installed system cost,” Gay says.
While thin films are less expensive than crystal silicon, they are about half as efficient, but they can be used in applications where there is limited space or unusual geometries to accommodate, and the films can be applied in tandem layers of materials that respond to different frequencies in the solar light spectrum.
“The potential is there for thin films to meet or exceed the efficiency of silicon,” Gay says, adding that Europe “tends to be out in front” in the development and application of thin-film technologies.
A future in films
Aggressive R&D into other materials and substrates notwithstanding, crystalline polysilicon still carries roughly 90 percent of the overall PV market, according to SEIA, but polysilicon is expensive and supply constraint looms as a near-term growth issue. Suppliers are poised to fill the gap.
Dow Corning (Midland, MI), for example, has developed a metallurgical-grade silicon called PV 1101, which is designed to be blended with traditional polycrystalline silicon so that users can extend their available supply of silicon. This product was released last year and has been tested in independent institutes and at several Dow Corning Solar Solutions’ customer production sites worldwide. Customer shipments of PV 1101 began last August.
“Customers have been successful using PV 1101 at various levels without losing any of the efficiency of the cells,” says Jarrod Erpelding, corporate communications manager with Dow Corning.
For many, though, thin films are the future. United Solar Ovonic (Auburn Hills, MI), for example, is exploring the use of amorphous silicon (a-Si) alloy thin-film technology to reduce materials costs. The material’s efficiency at absorbing light means the thickness of an a-Si solar cell can be 100 times less than that of cells made of crystalline or polycrystalline silicon. The company uses a flexible, stainless-steel substrate and polymer-based encapsulates; the cell is deposited using a vapor-deposition process at low temperatures, meaning the energy payback time is comparatively short.
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Miasol
Today’s critical environments must not only adhere to strict contamination control standards but also meet the needs of individual industries and customers. The flexibility and customization of clean spaces has become an important component of cleanroom design and build services.
Compiled by Jason Andrukaitis
Modular cleanrooms
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CEI modular cleanrooms are custom designed by a team of engineers for maximum space flexibility, modulation economy, and time and cost saving impact. All cleanroom components are specifically engineered for aseptic and sterile applications for cGMP facilities. Wall and walkable ceiling panels are manufactured in CEI’s plants in Syracuse , NY. Environmental zone control units are available in 5- to 60-ton capacity. Units, controls, and software are 21 CFR Part 11 compliant.
CEI Manufacturing, Inc.
East Syracuse, NY
www.ceicleanroom.com
Turnkey designed cleanrooms
Clean Air Technology, Inc. is a “design and build” cleanroom contractor and manufacturer for modular cleanrooms, on-site constructed cleanrooms, and biocontainment facilities. The company specializes in turnkey design, engineer-ing, construction management, installation, startup, and testing for ISO standard 14644, Class 3 to Class 8 cleanrooms. Cleanrooms can feature fully ducted HVAC systems or the negative return air plenum concept and custom-built HVAC equipment. The company supplies its products and services to the pharmaceutical, medical, electronics, semiconductor, and aerospace industries and university and government agen-cies worldwide.
Clean Air Technology, Inc.
Canton, MI
www.cleanairtechnology.com
Specialists in needs analysis
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CleanAir Solutions’ cleanroom consultants promote the design-build approach to limit customers’ liability from potential errors in their own pre-written specification and places the responsibility back on “the specialists” to provide the best design solution. A needs analysis worksheet helps accurately assess each customer’s requirements and ensure that the company does not create guidelines that impact the overall goal of the project. CleanAir Solutions carefully analyzes the client’s process for proper evaluation of the program and takes into consideration the various factors affecting cleanroom performance. Design experts specialize in integrating existing site conditions into new construction plans.
CleanAir Solutions, Inc.
Fairfield, CA
www.cleanroomspecialists.com
Design and build services
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Clean Rooms West, Inc. provides consulting services for the microelectronics, semiconductor, medical, food, and pharmaceutical industries. The company has delivered more than a million square feet of cleanroom space since 1991, based largely on its ability to provide a full range of services, including design and building of modular and conventional cleanrooms, certification, validation support services, system evaluation, electrical systems, exhaust and utility systems, and mechanical design. CRW works with customers to review allocated space, process needs, compliance to codes, certification/validation requirements, and value-added engineering concepts. Scope of work, facility specification, and concept drawings are then developed for consultation. Changes to meet customer requirements are implemented, and the preliminary consultation is reviewed. Project budgets are then analyzed and value-engineering concepts are added to comply with project feasibility.
Clean Rooms West, Inc.
Tustin, CA
www.cleanroomswest.com
Modular cleanrooms
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Connecticut Clean Room Corp. offers modular cleanrooms that are quick, easy, and cost-effective to build. The company’s designs also allow for expansion or reconfiguration of existing enclosures. Unlike stick-built or conventional-type cleanrooms, modular systems can be easily modified, assembled, and disassembled. In the event of a company move, customers’ modular rooms can easily be transferred from one facility to another. Some features include energy efficiency, full HEPA ceiling coverage, unidirectional airflow, and a variety of panel choices that can be used with existing walls.
Connecticut Clean Room Corporation
Bristol, CT
www.ctcleanroom.com
Cleanroom consulting firm
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HDR has designed more than one million square feet of cleanroom space for academic, federal, and health care research facilities as well as corporate manufacturing facilities. The company’s work includes ISO 14644-1 compliant and Class 1 to Class 8 cleanrooms. HDR understands that cleanroom spaces are a significant part of today’s research environment and facility costs. The company works closely with end users and considers research or manufacturing goals, operating costs, and equipment acquisition and installation. HDR is an employee-owned architectural, engineering, and consulting firm that strives to manage complex projects and provide solutions to challenges for clients. Approximately 6,600 professionals, including architects, engineers, consultants, scientists, planners, and construction managers in more than 150 locations worldwide pool their strengths to provide solutions beyond the scope of traditional A/E/C firms.
HDR, Inc.
Omaha, NE
www.hdrinc.com
Wall and ceiling systems
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ModuSpace, Inc. is a manufacturer of a complete modular wall system for the pharmaceutical industry, with all integrated services inside the walls and ceiling. The company manufactures and installs aluminum or steel walls, walkable ceilings with integrated lighting fixtures, and completely flush windows and doors. The system allows the company to implement quick installations without contamination, as its product is pre-installed at the factory and each panel closed on all sides. A short presentation of the company’s product is available on its web site.
ModuSpace, Inc.
Montreal, Quebec, Canada
www.moduspace.com
Turnkey and cGMP facilities
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Pacific Environmental Technologies, Inc. is a full-service controlled environment construction company recognized for its technical expertise and service-minded professionals. The company designs and constructs turnkey R&D and manufacturing facilities for a variety of industries, such as solar power technology and semiconductor pilot plants, as well as cGMP facilities for tissue engineering, pharmaceutical compounding and aseptic fill, and other pharmaceutical, biotech, and medical device industry applications. The company can build facilities ranging from a 400-square foot ISO 7 (Class 10,000) modular cleanroom to a new 150,000-square foot facility requiring offices and conference rooms, engineering department, restrooms, cafeteria, warehouse storage, shipping/receiving department, and required ISO certified CERs for various R&D and manufacturing needs. As a licensed HVAC mechanical contractor, the company also provides a full line of in-house mechanical services.
Pacific Environmental Technologies, Inc
Corona, CA
www.peticleanair.com
Cleanroom design
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SMMA’s architects and engineers are experts in understanding and anticipating the transformational nature of cleanroom design. The company’s integrated, experienced team understands all aspects of controlled environments. They are well prepared to design for today’s needs and tomorrow’s regeneration. SMMA’s recent projects include MEMS facilities, nanotechnology research labs, fabrication rooms, university research buildings, proton accelerators, and semiconductor cleanrooms. Its clients include Analog Devices, Fairchild Semiconductor, MIT, IBM, Varian Associates, EMC, and Ohio State University. The company takes a business-based approach and offers vigorous cost control and energy management capabilities during construction and startup of a facility.
Symmes, Maini, and McKee Associates, Inc.
Cambridge, MA
www.smma.com
Cleanroom design services
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SMRT engineers and architects are leaders in the design and delivery of today’s advanced technology facilities. Their expertise and experience aids customers from early planning of projects through detailed technical design. Whether it’s research, clean manufacturing, nano-scale environments, or large-scale production and warehousing, SMRT’s engineering leadership and collaborative approach help meet each customer’s individual needs. The company offers architectural/engineering design, cleanroom design, tool accommodation, and high-purity piping services.
SMRT, Inc.
Portland, ME
www.smrtinc.com
Energy-efficient cleanrooms
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Technovation Systems designs and builds energy-efficient cleanrooms, utilizing its optimized bypass air-handling system and by using three different models for optimally determining the airflow rate specific to the cleanroom class, process equipment, and type of product being manufactured. The company also utilizes its dilution model to experimentally characterize the particle generation of various process tools and provide consultancy services for equipment selection. The company also provides expert DQ/IQ and OQ documentation and services for cleanroom validation. Technovation has developed productivity-enhancing USP <797> compliant cleanrooms for pharmacies. One of the benefits of the company’s cleanrooms is that they exhibit ultra-low bioburden due to the use of patented bactericidal BIO PLU™ HEPA filters.
Technovation Systems, Inc.
Midlothian, VA
www.cleanroomsys.com
Cleanroom construction and services
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Vectech has extensive experience in the design and construction of pharmaceutical and biomedical facilities. Its staff is available to provide services for project implementation, planning, and monitoring; this includes equipment specification and selection, review of bids, selection of a contractor, project management, and related tasks. By actively participating in the design and implementation of pharmaceutical processes in areas such as aseptic processing, contamination control, dust control, clean-in-place, sterilize-in-place, dry heat, and steam sterilization, the company has obtained the knowledge and skills needed for work in the contamination control industry.
Vectech Pharmaceutical Consultants, Inc.
Farmington Hills, MI
www.vectech.com
Compiled by Jason Andrukaitis
Dust emissions monitor
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The new Series PMT particulate transmitter is a reliable dust collector emissions monitor and leak detector. The standard particulate transmitter is designed for general maintenance planning and process protection applications, while upgrades can be made to enable low level monitoring and early warning leak detection. Adjustable linear or logarithmic output scaling enables trending of both the baseline emissions and the high peak emissions that are caused by filter cleaning cycles and developing leaks. The device also features a field-proven combination of induction and protected-probe technologies. The protective layers on the probe work in combination with induction-sensing to ensure reliable operation with all types of particulates, including moist powders and highly conductive dusts.
Dwyer Instruments, Inc.
Michigan City, IN
www.dwyer-inst.com
Single-use process systems
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AdvantaPure now provides single-use process systems to the pharmaceutical industry and other markets that can benefit from single-use technology. Consisting of silicone tubing, molded silicone components, and other processing-related parts, the systems offer cost reductions and increases in productivity. The company has long been manufacturing platinum-cured silicone tubing, hose, and molded silicone components such as Tri-Clamp® style fittings, container seals, and bottle stoppers. The advantages of single-use process systems over traditional stainless steel systems include reduced cross-contamination, decreased downtimes for cleaning, simplified cleaning validation procedures, flexibility for process system changes, and reduced material and labor costs. AdvantaPure also offers GammaTags that may be attached directly to process systems and components for reliable, electronic identification from manufacture through disposal.
AdvantaPure
Southampton, PA
www.advantapure.com
Liquid handling verification system
ARTEL presents its MVS® multichannel verification system with new features, including an advanced automation function for streamlined performance verification of automated liquid handlers. A rapid, easy-to-use system that provides NIST-traceable results, the MVS is now able to automatically measure target volumes in groups of microtiter plates to minimize manual intervention during liquid handler volume verification. The system’s improved user interface allows for more frequent volume checks and easy integration with existing liquid handling platforms.
ARTEL, Inc.
Westbrook, ME
www.artel-usa.com
Self-wringing mop
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Connecticut Clean Room Corp. is now offering the new self-wringing Roll-O-Matic® mop with ergonomic extendable aluminum and stainless-steel handle. It is suitable for applying disinfectant to floors, walls, and ceilings in controlled environments or for general use. Handles and refills are available in cold rolled steel and stainless steel. CCRC offers special products that meet all critical manufacturing, industrial, and sanitary standards.
Connecticut Clean Room Corp.
Bristol, CT
www.ctcleanroom.com
Ceramics for medical applications
CoorsTek, one of the world’s largest technical ceramics manufacturers, announces its new CeraPure™ line of ceramic materials developed specifically for medical and surgical applications. Including alumina, zirconia, and zirconia toughened alumina, all CeraPure materials are USP Class VI compatible. These ceramic materials also offer better dielectric strength, thermal stability, strength, hardness, and insulating capabilities compared to traditional non-ceramic medical component materials. Applications include electro-surgical, laser systems, and fluid handling.
CoorsTek, Inc.
Golden, CO
www.coorstek.com
Exhaust management system upgrade
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Edward announces the availability of “idle mode” for its ATLAS™ and TPU families of combustion exhaust management systems. Idle mode allows the abatement system to go into a standby mode with reduced fuel and water consumption when exhaust is not flowing from attached process equipment. The new capability is part of a continuous improvement program initiated by Edwards to reduce the operating costs and environmental impact of its vacuum and abatement systems. In idle mode, the system only consumes fuel to maintain the pilot flame and water to refresh the recirculation system once per hour. On an ATLAS, these levels represent a reduction of 89 percent for fuel and nearly 100 percent for water. Idle mode can also be provided as an upgrade to existing TPU systems where an even higher percentage of fuel reduction can be achieved. The system monitors signals from process equipment to determine active and idle status. It enters idle mode automatically and can return to full operational status within 10 seconds.
Edwards Ltd.
Wilmington, MA
www.edwardsvacuum.com
R&D, process development system
Finesse Solutions, LLC, a manufacturer of measurement and control solutions for life sciences process applications, has announced the general release of its TruViu™ RDPD system for biotech R&D and process development applications. The system consists of an I/O tower and a pump tower, with an optional junction box and TruFlow™ gas manifold, all the components required to control a typical R&D or PD bioreactor. The product is designed to be flexible and modular with plug-and-play configuration in order to maximize ease-of-use, simplify installation, and provide scheduled maintenance. The modular design allows its components to be installed on, under, or above the laboratory bench, thereby permitting a significant footprint reduction and greater lab space efficiency.
Finesse Solutions, LLC
Santa Clara, CA
www.finesse.com
Aseptic pumping system
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The single-use aseptic, peristaltic pumping system from Flexicon America utilizes a closed fluid pathway in which the containment tubing becomes the pump. The closed tubing system and gentle peristaltic motion permits contained cytotoxic liquids to be installed and dispensed within a convenient, easy-to-use, easy-to-change, fully contained fluid product pathway. Unlike traditional piston-pump filling operations, in which manual loading and unloading of materials requires CIP and SIP processes that exposed workers to cytotoxics, the single-use closed peristaltic system eliminates measuring and filling of cytotoxic liquids by workers on the filling line and requires only a simple change of tubing with no CIP wash-down required prior to loading or changeover within the isolator. By pairing the single-use peristaltic system with an isolator, a biopharmaceutical manufacturer or contract filler is able to eliminate physical plant expansion costs, land acquisition, and time delays associated with construction of a dedicated cleanroom.
Flexicon America, Inc.
Burlington, VT
www.flexiconamerica.com
Air samplers
SAS-ISO from International pbi is the new generation of SAS samplers for the microbiological testing of air. The principle is the impact of microorganisms onto the agar surface of a contact plate or standard Petri dish. The air sampler uses a single certified aspirating head made in stainless steel or aluminum or Dispo-Head certified sterile, disposable plastic head. The disposable head complies with official guidelines requesting a traceable document of certification for sterility. The Dispo-Head may be used for each sampling or for each group of sampling cycles in the same environment. The SAS-ISO offers traceability functions such as date, operator name, sampling location, volume of aspirated air, and more to be transferred to a printer or PC. Several SAS-ISO air samplers of different locations can be connected all together to a PC for centralized control over environmental monitoring.
International Pbi S.p.a.
Milan, Italy
www.internationalpbi.com
Multispectral imaging workstation
Cambridge Research & Instrumentation, Inc. (CRi) announces the launch of Nuance 2, an affordable, breakthrough system that converts any brightfield or fluorescent microscope into a multispectral imaging workstation. For multispectral imaging analysis of larger specimens, such as embryos, zebrafish, plants, tissue cultures, and microtiter plates, the Nuance 2 can be mounted onto a fluorescent macroscope. The Nuance 2 features new analytical software providing the user with enhanced spectral unmixing tools and more efficient CCD cooling for better low-light imaging. Spectral library building is now easier, automatically identifying spectral signatures and properly identifying true spectral signatures when combined or overlapping. Nuance sensitivity has also been improved, allowing discrimination of co-localized markers.
Cambridge Research & Instrumentation, Inc.
Woburn, MA
www.cri-inc.com
Continuous mode emulsifier
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The KD Scientific Model KDS 330 is designed to operate unattended to emulsify eleutherosides and other components of the adjunct composition. The product can create viscous fluids/suspensions by forcing fluids back and forth through a micro-emulsifying needle. The pump eliminates the fatigue and time required to manually prepare emulsions. The KDS 330 also prepares adjuvant/antigen mixtures to the correct viscosity for injection. Through the menu-driven program, the user enters the syringe diameter, flow rate, and dispense volume. The pump automatically performs the calibration and control functions. When in emulsion mode, the pump cycles from infusion to withdrawal continuously. The unit automatically infuses and withdraws the preset volume. The pump is based on the Model KDS 210 in continuous mode for cycling back and forth and is specifically designed for a 10cc glass syringe and emulsion needle. Two syringes and one emulsifying needle are supplied with the pump.
KD Scientific, Inc.
Holliston, MA
www.kdscientific.com
Disposable mixing system
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The Mobius™ MIX100 disposable mixing system is now available featuring a configurable 100-liter container. Its integrated impeller enables risk-free cell culture, media, and buffer preparation; magnetic motor technology eliminates warm-up time. The mixer can be easily and economically configured with a wide array of containers, filters, connectors, and tubing for a completely validated disposable system. The MIX100 system offers all the advantages of Millipore’s scalable, ready-to-use systems and processing technologies: including decreased risk of contamination; reduced downtime for cleaning; validation, quality, and regulatory compliance support; and enhanced flexibility. Millipore will also launch additional mixers in various sizes over the next several months.
Millipore Corp.
Billerica, MA
www.millipore.com
Vacuum inlet trap
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A low-cost, vacuum inlet trap that is designed to prevent pump failures in smaller laboratories and features a new, optional wall mount bracket is being introduced by MV Products. The Visi®Trap vacuum inlet trap has a clear sump for visually monitoring filter condition and accepts a variety of replaceable filter elements for trapping foreign materials that could damage the pump. Suitable for pumps up to 20 CFM, this see-through inlet trap can adapt to different processes and is now offered with an optional wall-mount bracket for easy installation. Available with all popular port terminations, the trap can be supplied with copper gauze, stainless-steel gauze, molecular sieve, Sodasorb®, activated charcoal, activated alumina, and PolyPro 2-, 5-, and 20-µm filter types to protect pumps from particles, acids, solvents, or water vapor. Other options include a dial gauge assembly and vent valve.
MV Products, Division of Mass-Vac, Inc.
North Billerica, MA
www.massvac.com
Ultra-clear PET bottles
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A new “Special Round” 16-oz. ultra-clear PET bottle intended for packaging of personal care, household, automotive, and industrial products has been introduced by Novapak Corp. The bottle (Mold 1076) has an M28SP410 neck finish, measures 6.978 inches in height, 2.750 inches in diameter, and has a 3.710-inch high recess for adhesive labeling. It is injection-stretch blow molded from a 36.5-gm universal preform in a two-stage process that increases blow ratios, PET molecule orientation, and strength of the blown container.
Novapak Corp.
Eatontown, NJ
www.pvcc.com
ESD-safe swabs
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Puritan Medical Products, LLC, a leading manufacturer of specialty-tip applicators, announces the introduction and general availability of the company’s new electrostatic discharge (ESD)-safe swabs. The new products, an extension of the PurSwab line, feature ESD-safe polypropylene handles and include dissipative foam and ultra-clean microfiber-tipped applicators in both 3- and 6-inch lengths. With primary applications in microelectronics and critical environments, ESD Safe Swabs protect electronic circuitry and devices from the negative effects of electrostatic discharge. Puritan Medical Products will expand the ESD Safe Swabs product line in 2008 by manufacturing ESD Safe Swab versions of its most popular critical environment swabs.
Puritan Medical Products, LLC
Guilford, ME
www.puritanmedproducts.com
Electrical safety testing application
QuadTech, a leading provider of electrical safety test and passive component measurement solutions, reveals CaptivATE 3.2, the latest version of its electrical safety testing automation software. A key feature in the updated software is the ability to output test data to a .csv file for easy import from CaptivATE into any enterprise system, such as a manufacturing execution system (MES). The following QuadTech products are supported by CaptivATE 3.2: All Sentinel systems; Guardian 6100 and 6100 Plus electrical safety analyzers; Guardian 6000 Plus electrical safety analyzer; Guardian 6000 electrical safety tester; Guardian 1000 multi-purpose AC/DC/IR/SC series hipot testers (CE Mark); and the Hybrid 2000 AC/DC/IR/DCR analyzer.
QuadTech, Inc.
Maynard, MA
www.quadtech.com
Antimicrobial-treated lockers
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Lyon antimicrobial lockers are finished in an advanced powder coating technology from DuPont and Agion® Antimicrobial that inhibits bacterial, mold, and odor build-up on locker surfaces as well as the touch transfer of microbes on locker handles and doors. Moisture triggers the controlled release of powerful silver ions to provide superior antimicrobial protection for decades. These silver ions are noxious even to the drug-resistant MRSA bacteria. The antimicrobial compound is completely inorganic, less toxic than ordinary table salt, less irritating than talcum powder, and has been approved for medical devices and food contact applications. The cost for this protection is nominal, since it is reported to last for the estimated 20-year lifecycle of the locker.
Lyon Workspace Products, LLC
Aurora, IL
www.lyonworkspace.com
Recirculating chiller for clean process and research applications
Thermo Fisher Scientific Inc. has expanded its line of recirculating chillers with the addition of the NESLAB ThermoFlex 2500 unit. With continuous cooling capacities of 25,000 W, this recirculating chiller can be used for diverse applications in a variety of environments, including semiconductor, packaging, analytical instrumentation, laser, laboratory, medical, and research. A variety of configurable options is available to tailor the chiller to specific applications. Each chiller incorporates a recirculation system with integrated funnel, full flow filtration, and visual fluid level indication for easy maintenance. Most chillers must be taken off-line for up to an hour during scheduled maintenance, but the air and fluid filters on ThermoFlex units can be changed while the equipment is running, eliminating downtime. The shipping container incorporates an integrated ramp that allows a single person to unpack and install a unit in minutes. Efficiencies achieved with the new platform design provide up to 20 percent more cooling than units of similar size and power. The chillers can maintain temperatures from 5
When responsibility shifts to the contracted facility, qualifying the pharmacy for USP <797> is of the utmost importance
By Fran McAteer, MRA
In today’s modern hospital pharmacy, a strategy for effective USP <797> compliance is to outsource high-risk medications. High-risk compounded sterile preparations (CSPs) are prepared using non-sterile components. The non-sterile aspect of these admixtures requires the use of a sterile filtration process. Media fill proficiency testing of personnel is at a more complex and more frequent level. Environmental monitoring is weekly as opposed to monthly. With these additional precautions, some modern hospital pharmacies are implementing an outsourcing strategy to established contract compounding pharmacies. In this way, the high-risk application becomes the responsibility of the outsourcing agent.
Why do many hospital pharmacies outsource CSPs?
- Quality–the hospital may not have the facility, space, or equipment to effectively produce the medication.
- Capacity–a hospital pharmacy may need additional capacity depending on various factors such as staffing shortfall, patient needs, facility construction, etc.
- Cost–it may be a simple matter of cost allocation where the outsourcer offers a lower cost of compounding.
In this strategic decision-making process, it is important to qualify the outsourcing pharmacy for USP <797> compliance. It is imperative that the hospital pharmacy research the third-party compounding operation for quality of CSPs. The hospital pharmacy is ultimately responsible for all medications that it supplies to its patients. Senior pharmacy management should perform a non-biased assessment of USP <797> programs at a potential outsourcing candidate. Outsourcing agents should furnish a list of services, including existing quality checks for ensuring the integrity of IVs, syringes, and other products that they consistently supply to their customers. This should incorporate information on compounding procedures, cleanroom applications, trained personnel, expiration dating, and stability programs. A hospital pharmacy can request a list of <797> procedures or may even provide the outsourcer with a quality-oriented questionnaire to better formalize responses. This at least provides baseline information in regard to overall quality. The best way to ascertain this information is to visit the compounding operation. Following is a description of an approved vendor program at a large urban hospital. It involves an on-site audit of the compounder’s facility to assess its commitment to <797>. This audit involves inspecting the physical cleanroom areas, observing personnel aseptic technique, reviewing compounding batch records, and checking labeling and final product storage.
When discussing a potential contract with an outsourcer, request a visit to the site where the medications will be prepared. It is a good idea to send an audit agenda to the appropriate quality representatives of the contracting organization a few weeks before the actual visit date, giving the contractor some time to prepare the information that is requested. The agenda should request a facility tour, a review of specific CSP admixture documentation (preferably a CSP that is already being produced for the hospital), a check of personnel training records, and an audit of sterility, pyrogenicity, and stability test data.
Once on site, check out appropriate licenses such as FDA, BOP, and DEA. A facility tour will help establish a sense of the organization, segregation, material, and personnel flow. Observe the cleanroom facility, look for certification to ISO standards, and observe a CSP being prepared while watching for appropriate cleanroom personnel garbing and aseptic technique. Look for dirt, clutter, and cardboard in the cleanroom; these increase potential contamination. Ask about the frequency of cleaning and sanitization programs. In touring the facility, inspect how material enters and exits the cleanroom. Pay close attention to segregated quarantine, raw materials, and final storage areas as a source of product mix-ups (especially if multiple products are being supplied to multiple hospitals).
After the physical assessment, initiate documentation review. Review environmental monitoring programs, with concentration on data that is above action levels. Is there a corrective action program? Follow a batch record for tracer information; this traceability from the batch record should include appropriate test data such as final pH, sterility, and endotoxins. Personnel training records for the indicated compounding personnel should be inspected for appropriate media proficiency and gowning certification. Equipment maintenance and calibration records should be reviewed and labeling inspected for appropriate information including medication, lot numbers, expiration dating, and NDC numbers.
At the completion of the visit, provide the contractor with a summary of the findings regarding <797> compliance. This meeting is not for discussion, but a list of findings should be presented. The close-out meeting signals the formal end to the facility tour.
Upon returning to the hospital after the visit, provide senior management with a formal report candidly discussing the overall finding. Findings should be categorized as major observations, minor observations, and recommendations. Major observations include critical issues regarding <797> compliance such as failure to do sterility tests, no environmental monitoring program, or insufficient cleanroom facilities. These are issues that impact the overall CSP quality and may eliminate the outsourcer as a supplier for that CSP. Minor observations lack the immediate impact on CSPs and can easily be corrected–lack of appropriate procedures for ancillary tasks, failure to change out tacky mats on a regular basis, etc. Recommendations are minor points that the hospital pharmacy may desire to occur during the preparation of their CSPs–points of discussion that enhance quality systems or a particular method of operation that encompasses unique measures that may be employed by the hospital pharmacy. Once the report is produced and reviewed by senior management, it should be conveyed to the outsourcer. The report may request a follow-up response to the findings within 30 days. Upon receipt of the contractor’s responses, a review with final status should be prepared as Approved, Approved upon Impending Action, or Non-Approved.
This type of approved vendor program provides hospital pharmacy with the due diligence needed to assess the quality levels of a potentially new outsourcing partner, effectively managing multiple outsourcing partners for overall quality and <797> compliance. It also gives the outsourcer the ability to showcase its quality program, which should demonstrate its ability to attract future business.
Fran McAteer is vice president at MRA, an FDA registered laboratory. The author has experience in implementing USP <797> for many hospital pharmacies.
February 28, 2008 — /BELLEVUE, WA/ — Pharmacy OneSource, creator of the Simplifi 797 quality assurance web application, is pleased to announce that industry expert Eric S. Kastango, MBA, RPh, FASHP, CEO of Clinical IQ, has updated the included policies and procedures reference section in Simplifi 797 to match USP’s revised chapteron pharmaceutical compounding, “Sterile Preparations.”
The revised chapter was finalized in December 2007 and tightened standards and conditions for sterile compounding over the previous version of Chapter 797. These revisions will become official on June 1, 2008.
“Policies and procedures are the foundation for a robust compounding quality system,” says Kastango. “I’m very excited that Simplifi 797 has these updated policies and procedures to complement the outstanding software that provides pharmacists and technicians the tools to be successful.”
Simplifi 797 is a web-based application that automates, integrates, and streamlines the quality activities and documentation required to meet USP Chapter 797. Simplifi 797 manages task scheduling and monitoring, and automates the reporting of exceptions and compliances.
About Pharmacy OneSource
Pharmacy OneSource is pharmacies’ number 1 software-as-a-service provider. Its 50 innovative team members provide best-in-class SaaS solutions to current and future challenges within health-system pharmacies worldwide. Its SaaS solutions contribute to high performance pharmacies through better outcomes, lower costs, and system-wide results. More than 1,000 healthcare organizations worldwide utilize the company’s HIPAA compliant web-based services, including Accupedia,Amplifi, Quantifi,ScheduleRx, Sentri7, Simplifi 797, and UnitStock.
Visit www.pharmacyonesource.com
About Clinical IQ
Clinical IQ, LLC is a privately held consulting company based in Florham Park, NJ. It is led by Eric Kastango, MBA, RPh, FASHP, President and CEO, who is seen as an expert in many areas of the pharmacy industry, but particularly in USP Chapter processes. Clinical IQ, LLC aims to serve as the trusted source for pharmacy information services and product solutions for all its customers who range from local start-up operations to established national companies in the hospital, home care, and specialty compounding industries. With this aim, Clinical IQ creates software, classroom training, web based training, audit tools, and many other informational products to make sterile compounding and related areas of pharmacy safer.