Compiled by Sue Forsyth

Each month, CleanRooms brings you a collection of the latest product innovations in the contamination-control industry.

Water purification system

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The Elix Ultraviolet (UV) water purification system combines advanced purification technologies to provide users with pure water of consistent, optimal quality for a more efficient and robust performance. With distillation, specific ions and a number of organic molecules may be carried away with water vapor. Since these contaminants distill or co-distill more easily than water, the quality of the purified water is compromised. The Elix UV system incorporates reverse osmosis, electrodeionization and germicidal UV lamp purification technologies to effectively remove ions, organics, particles and bacteria. As a result, the system produces pure water that, for the majority of ions, has an ionic quality that is equivalent, and in some cases superior, to product water resulting from distillation. In addition, total organic carbon levels are significantly lower in the pure water produced by the Elix UV system than by distillation. The Elix UV system offers a maintenance solution consisting of easy-to-change cartridges and an automatic cleaning process that does not require the use of strong acid. Elix UV system users also appreciate the system’s environmentally friendly, low water and electricity consumption, which offers significant operational cost savings. The Elix UV systems are designed to meet users’ requirements ranging from 10 to 4,000 liters of pure water per day. Analytical-grade water produced by the Elix UV water system meets the specifications for Type II water as defined by ISO 3696/BS3997.
Millipore Corporation
Billerica, Mass.

Single-use bioprocess mixer

The Newmix single-use mixing system has a patent-pending, noninvasive design that does not allow contact of the impeller with the ingredients being mixed. In addition, it does not require expensive instrumentation to control the mixing process. Newmix is used for mixing active ingredients for intermediate and final drug products. Applications include pharmaceutical and biotech mixing of liquid with liquid, liquid with powder, and powder with powder under cleanroom/barrier isolator conditions. Newmix is the only single-use system that can effectively mix powders when powder content is >30 percent of the mixture. The Newmix vessels are manufactured with specially selected, medical-grade film produced with the company’s own in-house extrusion process under a controlled environment. The vessels are then assembled in an ISO Class 5 cleanroom to ensure optimal cleanliness and low particulate levels. Gamma irradiation is available upon request. The Newmix systems are ready for immediate use and offer greater process flexibility and enhanced process security, resulting in saved time, money and effort.
ATMI Packaging
Minneapolis, Minn.

Portable chillers

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The DuraChill industrial-capacity chillers are suitable for process temperatures from 14°F to 104°F (-10°C to +40°C) and are capable of providing up to 236,000 BTUs or more of heat removal. Temperature stability is +/- 2.0°F (+/- 1.11°C). Portable yet robust, DuraChill chillers are available in 1.5 to 25 HP models and in a wide variety of configurations. Standard features include digital microprocessor control with LED temperature readout, digital pressure and flow rate readout, high and low temperature alarms and remote on/off capability. In addition, each chiller can be equipped with the pump type-centrifugal, positive displacement or turbine-best suited for the cooling application. For optimum application and installation flexibility, the chillers are available with a broad selection of options and accessories. Popular options include wider process temperatures, serial output, remote temperature probe, remote control, DI-compatible process piping and higher-output pumps. For added convenience, these units can also be equipped with process shut-off valves, flow meters, recirculating pumps, tank-level indicators, automatic water make-up valves and other accessories.
Niles, Ill.

Noncontacting voltmeter

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The high-performance, noncontacting electrostatic voltmeter, Model 400, provides greater accuracy, faster speed of response and other user-friendly features. This product responds to the need of the electrophotography industry for increased accuracy and speed for electrostatic voltage measurement. Model 400 is intended for use by original equipment manufacturers for electrophotography quality control, by industry R&D in the development of new electrophotographic products and by university and industrial R&D for the purpose of exploring new technologies, techniques and applications relating to electrostatics. The Model 400 incorporates the company’s exclusive vibrating reed probe sensor and provides new features not previously available with any other voltmeter instrument in the marketplace. These features include greater accuracy and faster speed of response, which is insensitive to distance. Measurement accuracy is better than +/- 0.05 percent of reading +/- 0.5 volts at the monitor output and better than +/- 0.1 percent of reading +/- 1.0 volt at the DPM monitor. Either the dual-chopper probe (for applications needing higher speed of response) or the single-chopper probe (for applications needing low noise) can be used with Model 400. The frequency response of this unit is optimally flat over a wide range of probe-to-surface spacing. This means that there is no overshoot or undershoot when measuring step voltage changes. A noise null-control potentiometer allows the operator to null the output noise for whichever probe is being used. The benefit of this is that the user can achieve a very low noise level in order to more precisely detect the measured surface voltage.
Trek, Inc.
Medina, N.Y.

Gas detection system

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The newly improved TG-1900KBP portable formaldehyde (HCHO) monitor is a compact, battery-powered gas detection system with digital display for measuring extremely low levels of formaldehyde leaks and releases. An automatic sampling pump and instrument electronics allow connection to the built-in analog output to transmit gas concentration data to remote dataloggers and recorders. The instrument consists of a renewable amperometric electrochemical sensor cell that is specific to HCHO without responding to alcohol or other gases that interfere with PID- or FID-based formaldehyde detectors. This sensor can now detect as little as 0.01 ppm. It can also be used in laboratories, gas storage areas and other locations where formaldehyde may be used or stored. Simple to operate and easy to maintain, the TG-1900KBP is designed to provide reliable HCHO monitoring virtually anywhere it is needed.
CEA Instruments, Inc.
Emerson, N.J.

Magnetically coupled roots pumps

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This full line of magnetically coupled roots pumps offering pumping speeds ranging from 250 m3/h to 6000 m3/h are statically sealed against atmosphere. There is no wear of rotating seals and subsequent seal maintenance is not necessary. The leak rate specification for the magnetically coupled pump is <1×10-5 mbar l/s. The low leak rate assures that no gas will escape or enter the process, ensuring no exchange between the process and environment. In addition, the coupling is corrosion-resistant, allowing the pump to be used with aggressive media. The static seals also eliminate oil leaks that result from the wearing of rotary seals in ordinary roots pumps. All pumps of this line are fully compatible with the company’s existing roots pumps and accessories. Any standard IEC motor can be connected to these pumps, which are suitable for a variety of applications including: chemical engineering and process engineering, coating, semiconductor industry, research and development, mechanical engineering, metallurgy, packaging industry and freeze drying.
Pfeiffer Vacuum
Asslar, Germany

Dry disconnect couplings

These dry disconnect couplings are specially designed for the clean, efficient transfer of chemicals, solvents, fuels and hazardous materials. These couplings, available in stainless steel, aluminum or brass in sizes from 1.5 inches to 4 inches, allow for the easy connection and disconnection of hoses and pipelines while eliminating accidental spillage and product loss. Engineered to be user-friendly in its operation, the dry disconnect coupler features a built-in swivel that allows the operator to use a simple “push and turn” action to connect and start the flow of product. The valve will not open until the coupler and adapter are connected, thereby eliminating accidental flows. A similarly easy “turn and pull” action disconnects the coupler and stops the product flow. With this design, accidental spillage is impossible. The company’s dry disconnect design options include ANSI 3156 stainless-steel, brass or aluminum housings, Hastelloy C276 internal parts, Teflon bushings and Viton seals. Alternative seals and other design options are also available to fulfill special customer needs. The couplings have a standard working pressure of 260 psi for aluminum and 360 psi for brass and stainless steel.
Dixon Valve & Coupling Company
Chestertown, Md.

Filtration system

The FS11000 top-mount containment system series is now available, featuring the bag-in/bag-out HEPA filtration system. The technology provides protection while working with potent compounds, medicines and drugs, chemical agents and highly toxic materials up to Class III. The unique design allows only filtered air to come in contact with the fan while providing for a safe filter change.
Flow Sciences, Inc.
Leland, N.C.

Sterile-to-sterile connector links

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The Lynx sterile-to-sterile (S2S) connector is a single-use device for linking presterilized fluid paths in biopharmaceutical processes. The device facilitates secure connections in upstream and downstream processes as well as final fill and finish processes. It supports a broad range of applications, particularly sterile liquid transfer and microbiological sampling. The design of the connector allows the assembly of fluid paths in both classified and nonclassified environments. A sterile fluid path is enabled by connecting the device’s male and female couplings. Gamma compatible up to 45 kGy, the connector is available in individual sets or in quantities of 12 or 24 nonsterile packs.
Millipore Corporation
Billerica, Mass.

Network-centric RGA automation platform

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TOOLweb RGA monitors process integrity and tool performance in real time, identifies process excursions and generates alarms and targeted e-mail messages. It incorporates sensor-level FDC as well as data reporting and searching capabilities, and provides comparisons of wafer-to-wafer, chamber-to-chamber and tool-to-tool data. TOOLweb RGA components include a process-specific RGA, a tool connectivity component such as the MKS Blue Box or access to the tool’s secondary SECS port, and the company’s Process Eye Professional RGA control platform running recipe modules. TOOLweb RGA functions as a data source for the company’s TOOLweb connectivity platform or the factory host via TOOLweb tool-side protocol, SECS/GEM or custom interfaces. It offers browser access to data reporting, data searching and univariate FDC modeling capabilities. TOOLweb RGA is network-centric, with Ethernet connectivity down to the sensor level. Sensors monitor process-gas pressure, composition and stability as well as contaminant levels throughout the process, generating alarms (including e-mails to specific user groups) and stopping the tool if required. This minimizes the cost and yield impact of tool downtime. By speeding PM and other downtime recoveries, TOOLweb RGA maximizes tool uptime and provides a highly cost-effective means of maintaining and troubleshooting vacuum tools.
MKS Instruments
Wilmington, Mass.

Tank-level transmitter

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The Model 360 tank-level transmitter dramatically improves CIP/SIP recovery time. During a CIP process, temperatures exceed 180°F. Sensors generally require four to six minutes to recover before maintaining accurate readings. The Model 360 recovers in less than one minute, minimizing costly downtime and wasted process media due to inaccurate readings. The Model 360 features less than one minute CIP/SIP recovery time, flush Hastelloy® diaphragm, all stainless-steel construction, NEMA 4X enclosure, 3:1 ranging and internal zero span adjust.
Viatran Corporation
Grand Island, N.Y.

PLC couplings

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These PLC couplings incorporate the company’s IdentiQuik smart technology. The IdentiQuik PLC series couplings use radio frequency identification (RFID) to electronically verify line-connection accuracy, and capture fluid and product data from point-of-origin through point-of-use. This capability helps medical-device manufacturers and processors comply with 21CFR Part 11 regulations. IdentiQuik connections integrate RFID into couplings and package closures or inserts. Before the final connection of the body and insert is made, the IdentiQuik coupling halves automatically exchange product data, enabling equipment to electronically identify the device type or connected media and its characteristics. IdentiQuik PLC couplings are useful for applications such as analytical instrumentation, compression therapy, deionized-water filtration and thermoelectric cooling assemblies. All PLC couplings offer a simple thumb latch that allows for one-handed connection and disconnection: an audible “click” indicates a secure connection. Integral terminations translate into shorter assemblies and faster installations. The PLC IdentiQuik series coupling is made from acetal thermoplastic. Operating pressures range from vacuum to 120 psi at 8.3 bar and temperatures from -40°F to +180°F.
Colder Products Company
St. Paul, Minn.

FCP medium for GasKleen filters

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The FCP medium removes molecular contaminants to sub-part-per-billion levels, helping to improve manufacturing yields in IC devices with features as small as 65 nm. This medium was developed to purify traditional fluorocarbon gases, including trifluoromethane and carbon tetrafluoride, as well as newer, environmentally friendly gases, such as heptafluoropropane (halocarbon 227) and tetrafluoroethane (halocarbon 134a). Designed for use with the company’s GasKleen point-of-use purifiers, the AresKleen inorganic medium has a high capacity for removing oxygen, moisture, carbon dioxide and other impurities via irreversible chemical reaction. The purifier assemblies are suitable for use as a drop-in replacement for traditional particle filters. The assemblies also contain an integral 3 nm filter for removal of particulate contamination.
Pall Corporation
East Hills, N.Y.

Sanitary hand-lever ball valve

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The Series BV3HL ball valve is useful for food and beverage, pharmaceutical and biotech industries. It incorporates PTFE cavity filler to reduce the threat of product entrapment in the valve, and the unit features 240-grit internal polish and polished clamp-end connections. Units are constructed of 316 stainless steel and Teflon. An integral ISO 5211 mounting pad makes field automation with electric or pneumatic actuators easy; the three-piece design allows the central portion to swing out for maintenance while leaving the ends clamped into the line. Pressure ratings are to 1,000 psig and temperature ratings are -40°F to +450°F for wide application usage. The ball valve is available in sizes from 1/2 inch to 4 inches.
Dwyer Instruments, Inc.
Michigan City, Ind.

Innovation Express service suite

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The Innovation ExpressSM is a series of services designed to help medical-device companies quickly identify, target, design and manufacture novel products. The Innovation Express services span the entire product-development cycle, and are organized according to three distinct phases: technology forecasting, product development and manufacturing system development. Innovation Express starts with market research and extends through equipment build, enabling the company to employ the use of parallel strategies that speed time to market. Because confidentiality and protection of intellectual property are essential for new-product development, all work funded by the Innovation Express customer becomes the intellectual property of that customer, who is encouraged by the company to file patent applications for new innovations. Technology forecasting identifies developing technologies that will impact the market two, five and ten years down the road, and leverages the company’s experience adapting advanced technologies to real-world situations. During product development, the company’s medical, electrical, thermal, chemical, software and materials engineers use research results based on one-on-one interviews, focus groups and customer surveys to turn product concepts into prototypes. Testing and evaluation is also performed during this phase to establish manufacturing feasibility, and more thoroughly examine the business case, such as return-on-investment and life cycle, for developing new innovations. Manufacturing system development is the culmination of Innovation Express. It not only requires diverse engineering expertise, but also the physical resources to construct a one-of-a-kind process for the large-scale production of new innovations.
Foster-Miller, Inc.
Waltham, Mass.

Ergonomically redesigned industrial vacuum

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The new CFM 118 provides workers with handy conveniences that make cleaning less strenuous. The combined power, small footprint and efficiency of the CFM 118 also helps manufacturers clean tight spaces more quickly and thoroughly. New additions to the CFM 118 include a wheeled 6.6-gallon collection container with handles for easy emptying, and optional container fitted with a paper-bag filter for safe recovery and quick disposal of debris. These add-ons complement existing CFM 118 features such as an external filter-shaker handle to keep the main filter free of clogging and maintain maximum performance, and a self-cooling bypass motor to protect the motor from burnout. The CFM 118 collects and retains dust and debris within its filtration system through a series of progressively finer filters, including an optional HEPA exhaust filter, that capture increasingly smaller particles as they move through the vacuum. The unit can be custom-designed with a multistage filtration system that is proven to trap 99.995 percent of particles down to and including 0.18 micron, ensuring that collected materials are retained within the vacuum.
Nilfisk-Advance America
Malvern, Pa.

Equinox pump

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The isolator version of the Steritest Equinox pump for sterility testing is optimized for use with the company’s Steritest and Steritest EZ sterility-testing devices. The pump delivers consistent testing in a secure environment and reduces overall testing time. Ergonomically designed, the software-controlled peristaltic pump can be installed in both glove and half-suit isolators. As a result, the pump offers lab technicians the safe, uniform transfer of drug samples from various packaging formats to the Steritest and Steritest EZ testing devices. Using the company’s mounting kit, the pump is affixed directly to an isolator worktable. Analysts can now download custom procedures from a computer onto the pump, which prompts them through selected standard operating procedures. A patented autoclose pump head simplifies the loading and unloading of the device’s tubing without the risk of damaging the isolator gloves. In addition, a pressure control system consistently monitors the pressure inside each canister. Its unique profile ensures perfect decontamination inside isolators, eliminating the risk of false positives. The Steritest Equinox pump is also available for sterility testing in laminar flow hoods.
Millipore Corporation
Billerica, Mass.

Adaptable workbench system

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The ergonomically designed series 7000 adaptable workbench system is a modular workstation that offers unlimited flexibility to accommodate changing and future needs. The series 7000 has received Class 10,000 [ISO Class 7] cleanroom-compliant certification. Ideal for a variety of applications, such as assembly, service, repair, research and technical work, the workbench can be tailored to suit the requirements of both the user and the application. Available as both a stationary and mobile workbench, it can be configured with legs and/or cabinet pedestals. Users can also custom-configure their bench by choosing from an extensive selection of accessories, including storage, shelving, lights, power beams and more. The cabinet drawers provide organized and efficient storage for parts, tools, components and accessories. A broad selection of dividing and partitioning accessories for drawer interiors is available. Users can also choose from a range of durable work-surface options, including plastic laminate, static-dissipative laminate, butcher block, stainless steel and satin-coat steel. The workbench system features heavy-duty construction, and is capable of supporting 1000 lbs.
Burlington, Ontario, Canada

Remote particle identification

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With Particle Finder, the size and number as well as the shape of airborne or liquidborne particles of 5 microns or larger can be detected and documented within 15 seconds. It’s possible to filter particles from suspensions or highly colored solutions through the filtr.AID technology and to count them quickly. The shape and size analyses enable the classification of the particles and, thus, the documentation of the particle status of the respective testing solution. Particle Finder allows simple data exchange and the identification of individual particles through the (remote) particle analysis. The company guarantees the ability to transmit the results of the Raman or EDX-based particle identification to any customer worldwide within 24 hours. Particularly relevant for the pharmaceutical industry, Particle Finder software on the integrated laptop supports particle measuring fully compliant to 21CFR Part 11. The system is used on-site in production facilities for printed circuit boards; and in the pharmaceutical industry, the system is used to control foreign particles in drugs. For sample preparation for the Particle Explorer systems, Particle Finder enables the customers to document blind and particle samples quickly and securely. The system enables component manufacturers, such as car suppliers, to verify the cleanliness of their products quickly and easily.
Rap.ID Particle Systems GmbH
Berlin, Germany

Cleanroom label product line

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For the microelectronic, medical and ESD markets, these labels feature state-of-the-art synthetic face stocks made of Mylar, polyester, polypropylenes and Tyvek with custom-designed top coatings to ensure imaging and printing. These products can be manufactured using a proprietary, patent-pending cleaning process resulting in ultraclean labels suitable for use in Class 1 to 1,000 [ISO Class 3 to 6] environments. This product features thermal transfer, direct thermal, laser, inkjet, dot matrix and pen written face stock for all in-process, lot-box and shipping-box identification. Complete in-house label and graphic design capabilities for custom products are available. Certificates of conformance accompany every manufactured lot.
CT International
San Luis Obispo, Calif.

Water-based condensation particle counters (CPCs)

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This family of three water-based CPCs, each having a different size range and features that produce the best results in a variety of applications, is available from TSI Incorporated. The Model 3782 water-based CPC is a lower-cost instrument that detects particles down to 10 nm, in concentrations <50,000 particles/cm3. The Model 3785 is a general-purpose instrument that detects particles down to 5 nm. It employs two detection modes for accurate measurements in concentrations up to 107 particles/cm3. Model 3786 detects ultrafine particles as small as 2.5 nm. Its 0.3 L/min flow rate produces excellent counting statistics. Because they use water as the condensing fluid, these water-based CPCs are especially useful for indoor air quality assessment, environmental monitoring, atmospheric and climate studies and cleanroom monitoring. The condensing element is externally accessible for easy maintenance. Real-time particle concentration, totalizer function and operating parameters, as well as a graph of concentration vs. time, are all viewable on the front-panel display. Data are directly accessible via standard interfaces.
TSI Incorporated
Shoreview, Minn.

Protective eyewear

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StarLiteSQUARED protective eyewear is made of an efficient construction design based on the company’s original StarLite protective eyewear. The patent-pending StarSquare design results in high-styling that is popular with both men and women. The square lens, small size and snug fit rival trendy sunglass styles. In addition to a superior first-impression style, StarLiteSQUARED eyewear is comfortable, featuring soft, flexible temples and a fingertip nosepiece, and, at less than one ounce, they are incredibly lightweight. StarLiteSQUARED offers excellent all-around impact protection-including full brow protection-and is durable enough to stand up to even the toughest work environments. The eyewear has been designed and tested to meet, and exceed, ANSI Z87.1+ standards. StarLiteSQUARED eyewear is also equipped with scratch-resistant, hard-coated, 100 percent polycarbonate lenses that last longer than nontreated lenses.
Gateway Safety, Inc.
Cleveland, Ohio

Cleanroom stationery product line

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The cleanroom stationery product line is suitable for use in Class 10 to 1,000 [ISO Class 4 to 6] environments. The line is manufactured with advanced polyethylene binding technology and has high tensile strength with excellent heat resistance that enhances copier and printer efficiency. The line uses proprietary, precision cutting technology guaranteeing consistent sizing and cleanliness, and features 18 lb and 22 lb weights in white, blue, yellow, green, purple and pink, 28 lb in white and blue, in 8.5” x 11” or A4 sizes. Notebooks, Post-its, continuous-feed and pens are coming soon.
CT International
San Luis Obispo, Calif.

Air-purifying respirators

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The TruAir line of air-purifying respirators are designed to fit virtually any budget. The respirators are made of a large, molded shell that helps make breathing easier. Traditional comfort specifications, such as a soft, foam nosepiece; nonlatex, elastic head straps; and an adjustable nose clip, help ensure that the respirators provide a quality fit. NIOSH-approved, the TruAir family of respirators comes in three levels of protection: TruAir, offering N95 level filtration; TruAir Plus, providing N99 filtration; and TruAir Ultra, supplying P100 class protection. All TruAir packaging features a detailed fit-testing protocol in three languages with accompanying pictographs to help ensure safe and proper use. When used properly, all TruAir models provide excellent protection against a variety of contaminants. However, it is essential to consult a safety professional to determine the TruAir mask that’s right for your application.
Gateway Safety, Inc.
Cleveland, Ohio


GAMP guide

The Good Automated Manufacturing Practice (GAMP) Guide: Validation of Laboratory Computerized Systems is now available. The new publication joins ISPE’s library of technical guides, developed in cooperation with global regulatory agencies and industry professionals. The guide is targeted to laboratory, quality and computer validation professionals responsible for defining and managing laboratory validation practices in regulated life-science industries. Information technology personnel supporting these systems, end users, software developers and suppliers of computerized laboratory systems will also benefit. With a focus on computerized laboratory instrumentation, data management, and analysis systems, the guide serves as a supplement to the broader GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture – GAMP 4. The new guide describes laboratory computer systems subject to good manufacturing practice, good laboratory practice or good clinical practice and the key elements involved in a system’s life cycle from initiation to retirement.
International Society for Pharmaceutical Engineering (ISPE)
Tampa, Fla.

Resource guide

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Pharmaceutical, nutraceutical, food, cleanroom and industrial manufacturers now have access to a comprehensive resource for packaging equipment purchasing and integration decisions with Engineering Resource. This guide provides descriptions, technical and material specifications, photography, and diagrams for machinery utilized at each stage of the packaging process. Detailed information, such as speed, diameter and recommended accessories, is also included. In addition, the guide lists product-specific advantages in an effort to direct manufacturers to the most efficient equipment for their particular operations. The handbook features the company’s stainless-steel conveyor systems, which are ideal for pharmaceutical, nutraceutical, food, chemical and cleanroom operations, as well as filler machines, pouch-drying systems, verification systems, buffer systems, ancillary packaging equipment and robotics systems. Manufacturers can also find a range of equipment that can be customized to meet specific needs.
AutoPak Engineering Corporation
San Juan, Puerto Rico

Desk reference

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This new, free desk reference is a comprehensive guide to precision weights and calibration services. The reference contains more than 100 pages packed with specifications, tolerance charts, descriptions, terminologies, definitions, frequently asked questions and order forms that make your selection and order process as easy as possible. The company’s Mass Standards Handbook, which is known throughout the industry for its valuable content, is also included in the reference. The desk reference contains a comprehensive section on the company’s extensive range of calibration services including: mass, pipette, temperature, humidity, thermal mass flow, pressure and electrical, time and frequency.
Thorofare, N.J.

Industrial electronic catalog

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This industrial electronic catalog addresses the specific needs of Colder’s global customers and is available in downloadable PDF format and on CD-ROM. The catalog features the company’s extensive range of quick-disconnect couplings and fittings for secure, dry-break fluid connections in industrial and electronic applications. Added to the catalog are four new product families and more than 100 new items. Product descriptions include technical and dimensional data in both metric and fractional formats, and quality images for easy product selection. The catalog contains a chemical compatibility guide, flow rate charts and a pictorial index to guide specifiers.
Colder Products Company
St. Paul, Minn.


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