Cleaning products are a vital part of ensuring that a clean environment is sterile and contaminant-free. But the type of clean space in question and the level of cleanliness that must be maintained will determine which products will accommodate your specific needs. This month’s spotlight offers a selection of solutions, wipes, and more, to keep your critical environment operating at peak cleanliness levels.

Compiled by Angela Godwin

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General-purpose wipers
Nova-Tech 1000 cleanroom wipes from Blue Thunder Technologies are general-purpose, nonwoven wipers that are absorbent, strong, and ideal for general wiping purposes. They are composed of a unique blend of absorbent cellulose and polyester to create low particle emissions levels as well as minimal nonvolatile residue and ions. These wipers are ideal for Class 100 to 10,000 [ISO 5 to 7] cleanrooms and are double-bagged with lot-to-lot traceability.

Blue Thunder Technologies
East Windsor, CT
www.bluethundertechnologies.com

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Cleaning system
Contec’s EasyReach Cleaning System allows users to effectively clean hard-to-reach vertical and horizontal surfaces. It extends reach, to clean over and under heavy equipment, hard surface floors and walls. The cleaning system utilizes a variety of dry and presaturated wipes that attach to a lightweight 4-inch x 10-inch (10.2 cm x 25.4 cm) mop head. It is compatible with many Contec substrates for wet or dry cleaning applications. Anodized aluminum extension handles are available in two lengths, 4 feet (1.25 meters) and 8 feet (2.5 meters).

Contec, Inc.
Spartanburg, SC
www.contecinc.com

Critical surface wipers

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KIMTECH PURE* CL3 Wipers with patent-pending Clean-Dry Technology from Kimberly-Clark Professional can be used for the most critical surface-wiping tasks in ISO Class 3 or higher cleanroom environments. The wipers are 100 percent continuous filament double-knit polyester. They absorb liquids on contact while still delivering the low particle and extractable levels expected from polyester wipers. KIMTECH PURE* CL3 Wipers are solvent- and abrasion-resistant, have four laser-sealed edges to minimize particle generation, are cleanroom laundered in water filtered to 0.2 micron to minimize the potential for ion contamination, and are double-bagged to maintain cleanliness. The wipers are also compliant with AAMI guidelines and gamma irradiated to a 10-6 Sterility Assurance Level (SAL).

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

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Aqueous waterless cleaning
PDQ Precision, Inc. manufactures and distributes the Mini-Max Cleaning and Waste Management Systems, which are particularly useful where pinpoint or precision cleaning is desired. This FDA-registered Class II device for cleaning medical equipment (E197753) has a variable steam vapor output (from 195 psi to 295 psi and from 500°F up to 1300°F) depending on user needs and applications. Laboratory tests have shown that sanitation and sterilization can be achieved with these systems as well (cleaning bacteria and removing spores from surfaces, as shown by NAMSA Labs results 06/04).

PDQ Precision, Inc.
San Diego, CA
www.minimaxcleaner.com

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Gamma irradiated disinfectant
Sporicidin offers its Disinfectant Solution and Gamma Irradiated Disinfectant Solution, both of which are FDA- and EPA-registered to provide 100 percent kill of all pathogenic vegetative organisms. The solutions are tuberculocidal, bactericidal, fungicidal and virucidal (lipophilic and hydrophilic), including oral, ocular and genital herpes and HIV-1 (AIDS virus). They are registered for use on hospital instruments and equipment and comply with the OSHA Bloodborne Pathogens Standard. The Gamma Irradiated Sporicidin gallon is double-bagged and ISO-11137-validated for sterility assurance for use in pharmaceutical cleanrooms and other critical environments. Sporicidin products are alcohol-free and are safe for surfaces, including stainless steel, glass, Formica, paint, chrome, vinyl and wood. No rotation is necessary.

Sporicidin International
Rockville, MD
www.sporicidin.com

Compiled by Angela Godwin

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Wire Belt Company of America, a leading developer of advanced conveyor belting solutions, has introduced the new Compact Grid™ Conveyor Belt, designed specifically to handle smaller, more delicate products, while providing a lighter weight, lower mass, and an open-mesh belt design that is ideal for high-speed cooling and drying operations. Engineered with a 70 percent open surface area, the Compact Grid is suitable for processes in which product coating, drainage, and liquid or air circulation are factors. The open stainless-steel design is ideal for cooking operations such as frying and baking, as well as for cooling freshly baked or freshly fried products in high-volume, high-throughput processes. The increased open area makes the Compact Grid easy to clean and maintain. Offering a tight wrap capability, the Compact Grid allows for improved conveyor-to-conveyor transfers, minimizing the chance for product yield loss in high-speed processing operations. Its rugged construction offers maximum strength under significant loads, lessening the time needed to maintain the conveying system and reducing the number of belt replacements over time.

Wire Belt Company of America
Londonderry, NH
www.wirebelt.com

Labeling system

The new Multivac 6000 Cross Web Labeling System features a redesigned dispensing head for optimal sanitation, easier operation with touch-panel display, and increased cycle speeds to accelerate production by as much as 33 percent. Its state-of-the-art design also ensures lower maintenance costs. The system applies a wide range of label sizes and can be used for RFID label placement. Suitable for applications in food, medical and consumer product manufacturing.

Multivac
Kansas City, MO
www.multivac.com

Filters for wafer cleaning apps

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Pall Corporation recently introduced the new Excellar ER filter, a 0.02-micron-rated filter that provides enhanced retention for improved contamination control, especially for critical newly emerging 65 nm and 45 nm device generations. This is the newest addition to the company’s UltiKleen™ Excellar family of PTFE non-dewetting filter membranes, offering chipmakers a suite of PTFE membranes that support filtration needs in critical wafer cleaning applications down to the 20-nanometer size of particle removal. These filters were specifically designed for the aqueous-based, gas-generating chemicals used in wafer cleaning.

Pall Corporation
East Hills, NY
www.pall.com

Ductless fume hoods

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Air Science USA has introduced its EDU Mobile Ductless Fume Hoods, which offer a low cost solution for clean air requirements. Designed to provide operator protection when using hazardous substances, the fume hoods feature: high-quality prefilter and carbon filters with efficiencies superior to 99.6 percent; mobility from laboratory to laboratory; easy installation with no ducting; and alarms that monitor filter, airflow, and filter lifetime.

Air Science USA
Fort Myers, FL
www.air-science.com

Silicone-based packaging material

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NuSil Technology, a manufacturer of silicone-based materials for healthcare, aerospace, electronics and photonics, recently announced the addition of EPM-2411-2, a low outgassing, one-part, silicone glop-top, to its line of electronic packaging materials (EPMs). The material is designed for the encapsulation of chip packages in devices where outgassing-related contamination poses a problem. The product exhibits the low stress and wide operating temperature ranges that are characteristically associated with silicone-based materials. It is stored and shipped frozen in 3 cc and 30 cc syringes, as well as 3- and 6-ounce tubes.

NuSil Technology
Carpinteria, CA
www.nusil.com

Cleanroom tables

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Clean Air Products has introduced Series 64 perforated stainless-steel cleanroom tables. The tables allow uniform airflow through the work surface, and eliminate eddies and stagnant air pockets that can exist on or above the work surface of solid-top tables. They feature a stainless-steel support frame and are ideal for vertical-flow cleanroom applications. Continuous-top and perimeter-frame models are available.

Clean Air Products
Minneapolis, MN
www.cleanairproducts.com

Vibration isolation workstation

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Minus K Technology, Inc., in a joint venture with Kinetic Systems, has released the MK26 Series Vibration Control Workstation™, specifically designed for ultralow natural frequency applications and negative stiffness vibration isolators, to provide a compact, passive vibration isolation workstation with excellent vertical and horizontal isolation efficiencies. The workstation is appropriate for a wide range of instruments, including analytical balances, cell injection, confocal microscopes, patch clamping, optical microscopes, wafer probing, sensor calibration, atomic force microscopes and other sensitive equipment used in semiconductor processing, telecommunications, aerospace engineering, and medical research. It can be configured for a wide variety of applications and customized with a broad range of vibration isolation workstation accessories. Other features include: ultralow natural frequencies; vibradamped frame; customizable accessories; easy to use, with no air supply or electric power needed; choice of tabletops; ergonomic styling; Class 100 [ISO 5] cleanroom compatibility, with Class 10 [ISO 4] available; and no maintenance.

Minus K Technology, Inc.
Inglewood, CA
www.minusk.com

Non-slip floor coating

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Stop-Slip™ HDV from Garon Products is a strong, chemical-resistant coating that offers non-slip traction. The high-performance coating is ideal for chemical, printing, or food processing plants. The aggressive “peak and valley” profile provides superior traction and prevents hydroplaning even when wet. With low odor and virtually no VOCs, it is suitable for indoor applications. The USDA-approved coating applies easily with a trowel or roller, and dries in 24 to 48 hours to a durable, easy-to-clean surface.

Garon Products, Inc.
Wall, NJ
>www.garonproducts.com

Filtration/containment system

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Fette, a leading manufacturer and supplier of tablet presses for both pharmaceutical and industrial applications, now offers Fette ABSOLUT filtration/containment systems for the containment and removal of active-compound and toxic-product dust during industrial and pharmaceutical production. The system filters extremely fine dust particles and aerosols, bringing pharmaceutical processing contamination levels down well below the most stringent occupational exposure limits (OEL). The system provides an extremely low airborne dust level during handling via the use of two HEPA filters that allow cleaned air to be reintroduced back into the production area with no impact on room-to-hallway air balancing. It features the use of submicron particulate filter cassettes in both the active filter and safety filter stages, providing: the ability to accept high levels of contaminants in the inlet air stream; guaranteed 24-hour system operation; the ability to dedust different tablet presses with one filter system without product cross-contamination; and integrated weighing systems to provide records of the quantities that have been extracted. The system can be used with coating pans, dedusters, granulating systems, tablet presses, or any other equipment and in any production environment.

Fette America
Rockaway, NJ
www.fetteamerica.com

Online ordering of replacement filters

Filtco, a leader in fume filtration and containment, has announced the availability of online ordering of replacement filters, making it easier to maintain hoods with the company’s brand replacement filters. Models are available for use in hoods made by Air Science, Astec, Captair Equipment (Bigneat and Crumair), Misonix Equipment (Labcaire), ESCO, and Semper. The online store is located at www.filtcofilters.com, and features: super activated carbon filters, HEPA, and pre-filters for all major manufacturers of fume hoods and forensic products; discounted online prices; short delivery time; guarantee of performance and quality; two easy ways to shop for filters-by the equipment you have, or by part number; payment accepted in various currencies (EUR, GPB, USD); shipping from locations in Europe and United States to reduce shipping costs; and the remaining balance of any factory warranty on your hood will be honored.

Filtco Filters
Fort Myers, FL
www.filtcofilters.com

DUV zoom lens for defect analysis

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In response to shrinking feature sizes on semiconductor wafers, data storage devices, and microelectronic components, Navitar has released its NanoVue 248 nm 4X Deep UV Zoom lens. The system works in the deep ultraviolet (DUV) light, enabling detection and characterization of yield-critical defects while effectively doubling the resolution limit of conventional visible light microscopes. The NanoVue Zoom lens is ideal for original equipment manufacturers’ (OEM) new product development and integration into DUV instruments requiring higher throughput. The lens is designed to work with 248 nm DUV infinity-corrected microscope objectives to enable optical inspection to under 0.1 micron and has a zoom range of 0.75X to 3X. When using the 100X objective corrected at 200 mm tube length, a zoom range of 75X to 300X is possible. The field of view (FOV) of 0.14 to 0.37 mm can be achieved when using a 100X infinity corrected DUV objective with a 2/3-inch format sensor. With 0.1 micron resolution, the NanoVue is designed for the highest resolution applications. An optional motorized version speeds the observation process and automation of critical image data acquisition. The small and flexible optical footprint enables a broad range of inspection and defect review tasks including: DUV reticle and photomask inspection; thin film measurement; wafer inspection; CD metrology; failure analysis; and process control.

Navitar
Rochester, NY
www.navitar.com

Thermocouple assembly for high-purity systems

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The Partek division of Parker Hannifin offers a new thermocouple assembly design that provides a reliable temperature monitoring sensor for high-purity fluid systems that traditionally use fluoropolymer components. Designated the TS Series, the assembly has been designed as an alternative to sensors for high-purity flow systems that are fabricated by bonding the thermocouple wires between fluoropolymer tubing elements, which can damage the wires’ insulation, creating a wicking path for the flow media that leads to eventual failure of the wiring. The probe is specially designed to fit into Partek’s new TS Series sensor. The tip itself is also sealed with fluoropolymer for protection and long life, and has minimal dead space and entrapment areas. A TS Series sensor can be specified with either a K- or J-type thermocouple probe. Mounting for the sensor is provided in the form of a compact T-shaped PFA fitting that can be installed into fluid lines to function as a straight union or a 90-degree elbow joint. The sensor element is installed into one leg of the T assembly, using a standard PFA compression ferrule set. The thermocouple is available for five tubing diameter sizes from 1/4 to 1 inch, or in a ‘jump size converter’ configuration. The thermocouple is suitable wherever accurate, low-latency temperature monitoring is required in fluoropolymer-based fluid systems.

Parker Hannifin, Partek Division
Tucson, AZ
www.parker.com/partek

Ergonomic fume hood

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Esco’s new Basic Fume Hood (model EFB-4AX) features combined single-wall/double-wall construction and sloped 8-degree work front, offering improved operator safety and ergonomics and simplified installation of service fixtures on the front panel. Other features include: standard vertical rising fail-safe counterbalanced sash; all metal construction; and it can be shipped unassembled to save storage space and reduce costly freight charges. Standard service fixture includes: 1 water outlet, 1 gas outlet and 2 electrical outlets, and it can be supplied with no worktop for easy adaptability to any work surface. In addition, the EFB has been independently tested and certified according to ASHRAE110 protocols. A full ASHRAE110 test report and certificate are available for download.

Esco Micro Pte. Ltd.
Singapore
www.escoglobal.com

Clear PVC hose

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The Flexaust Company, Inc. has introduced a line of clear PVC reinforced hose for a wide range of air movement, duct cleaning, and fume control applications. Flexadux® ADC is a medium weight PVC hose that is reinforced with a spring steel-wire helix and features a smooth inner surface to minimize friction loss and enhance airflow characteristics. Suitable for a variety of positive pressure and light vacuum applications, it has a wide pitch with a 9:1 compression ratio for tight bending and easy storage. Offered in sizes from 4 inches to 18 inches I.D. and standard 25-foot lengths, the hose can be supplied with a variety of accessories including clamps and J-lock connectors to permit quick connections in portable applications. Manufactured with FDA acceptable materials, this clear PVC hose operates over a 20°F to 160°F range and resists chemicals, weathering, and moisture.

The Flexaust Company, Inc.
Warsaw, IN
www.flexaust.com

Non-conductive filters

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Universal Air Filter has introduced its non-conductive filters, for applications where space is limited and the filter frame may contact electrically charged surfaces or backplanes. The company’s non-conductive Flex-Frame filters feature flame-retardant, polypropylene plastic designed to meet the stringent filtration and flammability requirements of Telcordia NEBS, CE and UL. The non-conductive, flexing design fits ever-shrinking equipment footprints and is ideal in applications that demand that filters “snake” around components or conform to a radius-type bezel or a curved track. Flex-Frame filters are available with Quadrafoam filter media in various pore sizes: 20 through 45 PPI (green), and 10 through 60 PPI (gray or black). A solvent-resistant, two-part bonding material unites frame and filter media, making them inseparable.

Universal Air Filter Co.
Sauget, IL
www.uaf.com

Reinforced silicone hose

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AdvantaPure, the sanitary products division of tubing-and-hose manufacturer NewAge Industries, has released its flexible braid-reinforced, platinum-cured silicone hose with a new treatment for the hose ends. Called APSH, the hose is now available with anti-wick seals to prevent liquid absorption within the hose walls, which is particularly important in industries such as pharmaceutical, bioprocess, food and beverage, chemical, and other clean applications. In addition to its anti-wick seal option, APSH is available with color-tracer braid in red, blue, yellow, green and purple and in a white-color, double-braid style for added durability. AdvantaPure manufactures all variations of APSH in HEPA-filtered cleanrooms, with key emphasis on cleanliness and validations. The hose is made from low-volatile-grade, platinum-cured silicone with braided polyester yarn between the hose walls to enhance its pressure and light-duty vacuum capabilities. It has undergone physical, chemical, and biological testing and meets USP Class VI, FDA CFR 177.2600, ISO 10993, European Pharmacopeia 3.1.9, and 3-A standards. APSH hose is suitable for either fluid or air transfer in a wide range of temperatures: -100°F to +400°F (-73°C to +204°C). It resists compression set, chemical attack, ozone, radiation, moisture, environmental exposure, and imparts no taste or odor to critical streams. It’s documented lot traceable with identification on bags and boxes and offers documented quality control as well. APSH may be sterilized by autoclave, SIP, CIP, or gamma radiation.

AdvantaPure, a division of NewAge Industries, Inc.
Southampton, PA
www.advantapure.com

Cleanroom mop system

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The Superior Cleanroom Wall Mop System from Superior Cleanroom Products provides effective and efficient cleaning of cleanroom walls and ceilings. The mop system incorporates a stainless-steel handle and holder, with a disposable wall-washing mop head comprising lint-free polyknit polyester wiping material laminated to an inner core of highly absorbent foam. The mop system is highly resistant to strong chemicals, and is available in a range of sizes.

Superior Cleanroom Products
Galway, Ireland
www.superior.ie

Endoscope disinfection system

The new EvoTech™ Endoscope Cleaner and Reprocessor (ECR) from Advanced Sterilization Products, a Johnson & Johnson Company, is a washer/disinfection system designed to eliminate labor-intensive manual cleaning of endoscopes. Recently cleared by the FDA, it’s the first and only such system in the U.S. that establishes a consistently high standard of automated endoscope cleaning comparable to professional society guidelines for manual cleaning. The EvoTech ECR is indicated for use with high-level disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high-level disinfection of heat-sensitive (>60°C), semicritical endoscopes. Manual cleaning of endoscopes is not required prior to placement in the EvoTech System when selecting those cycles that contain a wash stage. (Manual cleaning is required when selecting the “disinfect only” or “disinfect/alcohol flush” cycle.) EvoTech ECR will be available for purchase in the first half of 2007.

Advanced Sterilization Products, a Johnson & Johnson Company
Irvine, CA
www.cidex.com

Manual motor, fan controls

The B-Series VariPhase from AirCare Automation enables manual control of single-phase AC PSC motors and fans, and offers high-end features in an easy-to-use/install package. The internal microprocessor provides control of motor speed over a wide range, improving efficiency and adjustment accuracy. A user-selectable soft-start feature eliminates high-startup currents often found in AC induction motors. A minimum-speed-pot setting keeps motors/fans out of stall-current mode. VariPhase B-Series controls can be installed with shaded-pole or PSC motors. Other features include: 3-wire configuration to reduce humming noise; on/off switch that keeps existing speed setting; LED faceplate that notifies user of speed change; digital control for linear speed change; and easy wall-mount installation.

AirCare Automation, Inc.
Flushing, NY
www.aircareautomation.com

Transport pallet

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The Aero-Pallet from AeroGo, Inc. provides nearly frictionless, horizontal omnidirectional movement to easily move and position heavy loads (1 to 14 tons). It is suitable for manufacturing and assembly applications, transporting in cleanroom environments, and moving finished products to shipping, storage and testing areas. Features include quiet operation, no emissions and vibrationless movement.

AeroGo, Inc.
Seattle, WA
www.aerogo.com

Air monitor for isolators

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International pbi has introduced its SAS Isolator for simplified microbiological air monitoring of isolators and restricted areas. It features a stainless-steel sampling chamber that is separate from the operation unit of the air sampler, connected by a small cable to avoid bulky air tubing. The compact stainless-steel aspirating chamber can be positioned or suspended in any convenient place inside the isolator and is sterilized by VHP, with the operation unit outside. The operation unit can be connected to a printer or computer to record all sampling data. Routine calibration can be performed inside the isolator using the digital Pyramid anemometer.

International pbi S.p.A
Milan, Italy
www.internationalpbi.it

New Literature

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Components catalog
Qosina, a leading provider of stock and custom-made components including USP Class VI tubing, filters, hemostasis valves, plastisol connectors, swabs, applicators and more, announces the release of its 568-page catalog featuring thousands of OEM disposable components. The 2007 edition contains full-size color photos of all Qosina products, including over 550 new parts, on a handy one-centimeter grid for accurate sizing. The Qosina catalog is a useful resource for engineers, product designers and purchasing departments. It also offers an expanded section for laboratory products as well as packaging items, such as dispenser tip bottles, QosiPET™ vials and droppers, and syringes. To receive a copy of the 2007 catalog, call a Customer Specialist at (631) 242-3000 or send an email to [email protected].

Qosina Corporation
Edgewood, N.Y.
www.qosina.com

Safety and protection products catalog

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The 2007-2008 Cole-Parmer® General Catalog has 2,600 pages with more than 60,000 products-including 11,000 new items. The company’s innovative facility safety and personal protection product lines feature environmental monitoring instrumentation, protective apparel, spill control equipment, and more. All sales are backed by free applications assistance for the life of the product. To reserve a free catalog, call (800) 323-4340 or visit www.coleparmer.com/2010.

Cole-Parmer
Vernon Hills, Ill.
www.coleparmer.com

Cleanroom apparel catalog

Superior Uniform Group recently launched its new Worklon® catalog featuring cleanroom and controlled environment apparel and accessories for particle control, electrostatic dissipation, fluid resistance and bacteria filtration. ESD Lab Wear is offered in a variety of fabrics and styles. To view the new catalog, visit the company’s Web site.

Superior Uniform Group
Seminole, FL
www.superioruniformgroup.com

Fluid sensors catalog

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The Fluid Sensors and Diagnostic Systems 2006/2007 free catalog from ifm efector offers over 400 product solutions for process control applications. The easy-to-use, 415-page catalog features the following product lines: pressure and vacuum sensors; flow sensors; level sensors; temperature sensors; condition monitoring sensors; actuator sensors; power supplies; and wiring solutions. Products are organized by intended environment, including industrial automation, sanitary and hazardous applications. To order a free catalog, visit the company’s Web site.

ifm efector inc.
Exton, PA
www.ifmefector.com

Measuring, control instruments catalog

Dwyer Instruments, Inc., producer of a broad range of measuring and control instruments for pressure, temperature, level, flow and other related applications, has released its 2007 catalog, featuring a wide range of practical and affordable instrumentation in a convenient, easy-to-use format. Product ordering information is complete and includes schedules for discounts. Orders can also be placed, checked and tracked from Dwyer’s Web site. Inventories are stocked in factory-operated warehouses in the U.S., Australia and the United Kingdom. Representatives and distributors in 60 countries assure worldwide availability. To order a free catalog or for more information, visit the company’s Web site.

Dwyer Instruments, Inc.
Michigan City, IN
www.dwyer-inst.com

Labels catalog

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Computer Imprintable Label Systems LLC (CILS) has launched its new direct-order catalog and Web site featuring over 10,000 durable laboratory label products. A wide range of high-specification, customized and stock labels suitable for laser, thermal transfer, inkjet printing and handwriting are available. All labels are manufactured by CILS and are supplied in economical pack quantities or convenient booklets for slides, tubes, vials, plates, bottles, glassware and more. The new catalog and Web site enable fast and easy ordering with same-day online quotations for customized labels. To request a copy of the catalog, visit the company’s Web site.

Computer Imprintable Label Systems LLC
Beverly, MA
www.cils-international.com

The contamination control industry has accomplished much over the last few decades, and there is much to take pride in. Certainly among these accomplishments is the development and introduction of a host of new technology solutions and contamination control products for a number of user industries. However, now is not the time for the industry to rest on its laurels.

One of the greatest contributions that the contamination control profession has made to the industries it serves is education and training. Without having first educated the early-user communities (nuclear, microelectronics, aerospace, pharmaceuticals) regarding the consequences of poor contamination control practices, procedures and protocols, and the great benefits available through the implementation of new tools and systems, none of the industries that now embrace the technology would have seen how valuable it is. Similarly today, there are many other professions that are still largely unaware of the capabilities and advantages offered by a thorough understanding of the proper implementation of contamination control technology and practices.

One such major opportunity exists in the community of compounding pharmacists. Though some pharmacists are already well underway with the process of fully meeting new contamination control requirements in their practices, many others are resistant, largely due to a lack of knowledge about already-existing solutions or unrealistic fears of insurmountable up-front cost obstacles. Both groups can benefit from the experience and knowledge of contamination control professionals. No technology or product will be of use to this community if they do not first understand the impact and criticality of efficient contamination control itself.

Similarly, hospital hygiene across the board entails reaching an entirely new universe of healthcare professionals. Not one single death from hospital-acquired infection should be acceptable, let alone the thousands that occur annually in the U.S. alone. Once again, education is the first step toward driving new initiatives and implementations of contamination control science in an environment critical to us all.

Clearly, the food industry must also become better educated in contamination control and what is truly required to achieve complete and reliable results. Quality control is not contamination control. Cleaning and sanitation practices are not contamination control. It’s time for the food industry to step out of the past and into the real world of modern contamination control science and technology.

Overall, our industry must continue to reach out to offer education, training and support to forward-thinking advocates and early-adopters of contamination control science-on both the industry and regulatory sides.

John Haystead, Editor-in-Chief

To make the most efficient lighting selection, know your requirements and your options

By Robert Catone, Guth Lighting

Although the lighting field has seen many technological improvements over the last decade, many challenges remain for design teams working to specify the best technology systems for environmentally controlled environments. The biggest challenge is that there are no formal standards for cleanroom lighting, largely leaving the selection process up to whatever the specifier deems to be important and sufficient.

There are, however, a great number of clean-space standards that have a direct impact on proper lighting selection and installation, the most widely recognized being ISO 14644-1, which establishes the acceptable levels of particulates for various classes of cleanrooms. And, there are a great number of regulatory and inspection agencies-such as the FDA for the pharmaceutical and biopharmaceutical industries-that monitor and evaluate the cleanliness levels of lighting fixtures.

In the food industry, there are nine broad categories of processes (poultry, dairy, bakery, confectionary, meat, beverage, fish, vegetables and prepared foods), and there are numerous regulatory agencies (FDA, OSHA, USDA) that inspect for sanitation and safety. At the lighting equipment manufacturing level, the National Sanitation Foundation (NSF) International certifies fixtures for use in food-contact and splash-zone areas.

As a result, cleanroom and clean environment contractors and users need to have a thorough understanding of the different types of lighting, lighting fixture and installation options available.

Lamps

The best place to start is with an evaluation of the different types of lighting available for clean spaces. The most common lamps for areas below 10 feet are linear and compact fluorescent, with metal halide lamps reserved for higher mountings.

Among the most important factors to consider is lamp lifetime, taking into account not only the initial cost of the lamp but the cost to replace it. For example, in some cleanrooms, the relamping of a fixture may require recertification of the entire cleanroom because the fixtures have been opened up. This is why the new 40K-hour lamps are of particular interest in the cleanroom industry, providing eight years of lighting without having to change a bulb, and most users are happy to pay an additional $2 to $3 for the lamp.

Lamp lifetime is largely a function of the type of phosphor used. Lower grade phosphors, such as those used in F32T8-741 type lamps, equate to a cost of about $1.25/lamp but have a much shorter lifetime than the F32T8-XXL, which costs about $3.50/lamp but has a 40K-hour lifetime (see Table 1).

Color accuracy is also dependent on the type of phosphor used, with some of the newer phosphors providing much better color accuracy. In the table of linear fluorescent lamps, 82.5 is the lowest performance with the highest being 91.4. This relates to the relative color accuracy compared to incandescent lamps, which are rated at 100. Some specialized lamps can achieve accuracies as high as 95 percent, which is an important factor for some applications such as food processing where vegetable color in an inspection line is critical. Superior color accuracy can also be an important aesthetic factor for some architects. For most applications, however, color accuracy above 80 is adequate given the average ability of most individuals to discern differences.

Lamp types

There are several different lamp types available with varying performance characteristics to suit a range of applications.

Table 1: Performance characteristics of linear fluorescent lampsClick here to enlarge image

Linear fluorescent
These four-foot-length tubular lamps are available in varying levels of quality and performance, with the one-inch diameter T8 having replaced the T-12 as the standard. The metric 46” T5HO lamp is also being used with some exotic fixtures. These lamps operate best between 0°F and 85°F. Table 1 shows the performance characteristics of different linear fluorescent lamps.

Table 2: Performance characteristics of compact fluorescent lampsClick here to enlarge image

Compact fluorescent
These 4- to 11-inch lamps have become popular in down-lights and small architectural fixtures. In some cases, multiple lamps allow stepped light levels and energy management. They are replacing low-wattage metal halide in many applications. The starting temperature can be as low as -22°F. Lumen output is stable up to 140°F (see Table 2).

Table 3: Metal halide performance with electronic ballastsClick here to enlarge image

Metal halide
Metal halide lamps provide white light and are unaffected by temperature. Their starting temperature can be as low as -20°F. Lamp re-strike can take 2 to 6 minutes after a power outage. These lamps are used from 10 to 40 feet (see Table 3).

Specialty lamps, coatings and sleeves
In addition to the more commonly used lamp types described above, there are also a number of specialty lamps available offering unique features and capabilities. For example, induction lamps are an expensive fluorescent system operated by microwave energy. These lamps provide 100,000 hours of life and are available from 60 to 165 watts. They are particularly useful in cases where maintenance is expensive.

Another example is special color spectrum lamps, which have tinted sleeves or lenses to control UV or provide special colors for animal environments or custom applications. Break-proof lamps are available from coating companies and some manufacturers. Teflon is generally used to contain the broken glass.

Another option, light emitting diodes (LEDs) can provide 50,000 hours of life when properly heat sunk. These systems are expensive, however, and white-light efficiency is about 35 percent that of fluorescent lamps. It is the primary lamp for signage and exit lights.

Electronic ballasts

Electronic ballasts are the standard for fluorescent lamps and are also quickly becoming the standard for metal halide lamps as well (see Fig. 1). New, high, 1.3-ballast-factor designs increase T8 fluorescent lumens per lamp up to 35 percent. Since ballast life is shortened when case temperatures are at their limits, manufacturers also offer premium higher-temperature versions. Daylight harvesting, load shedding and automatic dimming features have all been integrated into the newer ballast designs, providing the following standard and optional benefits: efficient lamp performance, quiet operation, integral dimming or step dimming, end of life lamp shut-off, computer software control, self protection against overheating, universal voltage and lamp operation, small size and minimal weight, and higher T8 lumen per lamp electronics.

Fixtures

The next important factor to consider in cleanroom or clean-environment lighting selection is the type of fixture to be used. Again, cost can be a determinant. In general, stainless steel is the most expensive fixture material available, with aluminum falling somewhere in the middle range and painted steel being the cheapest. Aluminum housings provide the coolest electronic ballast and lamp operation, while stainless-steel housings operate hottest.

Figure 1. These electronic ballasts provide state-of-the-art operation for fluorescent and metal halide lamps. Photo courtesy of Advance TransformerClick here to enlarge image

Maintenance, lifetime and replacement costs should also be taken into account in addition to initial fixture prices. For example, many food and pharmaceutical plants will initially opt for cheaper, painted-steel fixtures only to find that after repeated wash-downs, the paint begins to flake or peel and the steel to rust, requiring replacement. It’s often just a question of whose budget will absorb these costs, and the individual responsible for the initial construction budget may opt for the cheaper steel fixtures without consideration to the person responsible for maintenance, whose budget will ultimately be affected.

Cleanroom class level is, of course, a critical consideration. For a Class 10,000 (ISO 7) cleanroom, fixtures are basically a standard unit with a gasket on the door. Additionally, some kind of gasket is used between the fixture and the ceiling grid system supporting it, but the fixture usually has minimal additional protection and in many cases may not be caulked.

For a Class 1,000 (ISO 6) cleanroom, however, all of the ceiling fixtures should be caulked and the fixture doors sealed as well. Some users may require that the lens also be sealed to the door frame. Still, the stringency of the installation will be largely dependent on the person writing the specification, with one person writing a spec for a Class 1,000 cleanroom that is much more stringent than someone else might write for the same class room.

The installer, as well as the fixture supplier, is also an important consideration, especially for sheetrock ceilings vs. grid systems. For example, the installer must cut openings into the sheetrock to house the fixtures. Typically, four brackets are used to hold the fixture in place, with the brackets basically torqued down against the sheetrock and the fixture sitting snugly against it. In some cases, however, the sheetrock ceiling is not perfectly flat (referred to as sag), leaving a gap between the flange of the fixture and the sheetrock. This will be a particular concern if using steel fixtures, which may weigh up to 60 lbs and will not help in maintaining the flatness of the sheetrock.

Aluminum fixtures, weighing about 16 lbs, are more forgiving but the installation contractor should still often be required to caulk the edges of the fixture. Again, it ultimately depends on the level of cleanliness that the user is interested in maintaining.

Fixture types

Recessed troffers, which come in myriad sizes, lamps, gaskets and construction types, are the primary fixture choice for many cleanroom, lab, pharmaceutical and food processing applications. Welded housings should be used with positive plenum pressure rooms. Lenses are generally installed with the smooth side out to reduce dirt accumulation, and louvers with a sealed underlay are available to lower glare in sensitive areas. HID metal halide lamps are usually available in 2’ x 2’ housings for high, insulated ceiling applications.

Surface fixtures are used when ceiling penetration is not desired, and these are available in many sizes, lamps, shapes, materials and gasketing levels to meet the most exacting requirements.

• Teardrop fixtures maximize linear airflow in Class 100 (ISO 5) cleanrooms. Smaller designs for T8 lamps enhance airflow. Lengths are available up to 16 feet.
• Tubes that are sealed and NSF-certified are most popular in food plants but have also found success in vivariums and Class 3 and 4 labs. A variety of lengths, stainless-steel endcaps and moveable mounting straps provide durability, amiable optics and versatility. Optical options provide task, inspection or general lighting.
• Wraparound fixture construction can be plastic, fiberglass, aluminum and caulked or seam-welded stainless steel. Gasketing can provide dust-tight and waterproof listings. Most of these fixtures find use in food processing areas where captive latches are a requirement.
• Lowbay fixtures with metal halide lamps are generally used above 15 feet in food facilities. Designs with smooth contours and rounded surfaces are most popular because they resist dirt build-up and clean easily.

Figure 2. Lowbays with sealed construction and prismatic lens can create an attractive aesthetic feature in a clean environment. Photo courtesy of Guth Lighting.Click here to enlarge image

Architectural fixtures are generally used in laboratories with open ceilings. Here, enclosed construction and ease of cleaning should be a priority.

• Lowbay fixtures use 1 to 8 compact fluorescent lamps. Customization provides accent colors that can add variety to the space. Fixtures are 12, 16 or 22 inches in diameter and may have sealed or open optics (see Fig. 2).
• Attractive wraparound and surface fixtures are available with enclosed or gasketed construction. A variety of sizes, lengths and finishes can meet most aesthetic requirements.

Cost factors

For new construction projects, lighting selection is usually not highly price sensitive because it will be relatively insignificant compared to the total cost of the building. Where it does become price sensitive, however, is on retrofits where contractors often try to use the lowest-cost option in order to increase their margins. Sometimes, the user may also wish to keep upfront costs to the bare minimum.

Advances in technology, when properly applied, provide many new ways to save energy and lower construction and maintenance costs in the cleanroom. In future, improved control systems and more efficient lamps will also continue to offer lower energy consumption and operating costs.

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Robert Catone is a certified lighting professional, the general manager of Guth Lighting and VP of the JJI Lighting Group. He is a member of the Illuminating Engineering Society’s Progress Committee and credited with 2 lighting patents. Guth (www.guth.com), a division of Genlyte Corporation, was founded in 1902 and specializes in fixtures for cleanrooms, laboratories, pharmaceutical manufacturing and food processing.

Routine testing ensures standards are being met

By Fran McAteer, Microbiology Research Associates, Inc.

This article presents a testing methodology for environmental monitoring (EM) of viable particles in a cleanroom. Viable particles are living microscopic organisms present in the aseptic environment, especially bacteria, yeast, and mold in the air and on surfaces. Thorough testing usually includes monitoring surfaces, personnel and air. Companies routinely test their cleanroom environments to ensure they meet required standards. Cleanroom operating standards are found in United States Pharmacopeia (USP) and European Pharmacopeia (EP), and International Standards Organization (ISO).

Viable sampling of air

For sampling, gravitational or settling plates are used. These are Petri dishes containing sterile growth media. They are passively exposed to the environment, usually for 30 to 60 minutes. Viable microorganisms that settle onto the media surface grow when the plates are incubated. Though settling plates offer ease of use and remain cost effective, they do not directly correlate microbial contamination with measured air volume and do not provide a quantitative measurement of air contamination.

Another approach is the use of rotary centrifugal air samplers (RCS). These active monitoring instruments measure an exact amount of air with a quantifiable number of viable microorganisms. Contamination can be measured per cubic foot or cubic meter of air (see Fig.1).

Viable sampling of surfaces

Contact or Rodac plates are also Petri dishes containing sterile growth medium. In this case, the agar protrudes above the sides of the plate. The convex contact plate is pressed against any flat, regular surface that needs to be sampled. Any viable microorganisms on that surface will adhere to the agar and grow upon proper incubation. This technique replicates the number of viable microorganisms on a surface. Contact plates are easy to use and widely available, but may not be appropriate for irregular surfaces.

Figure 1. Rotary centrifugal air samplers (RCS) are active monitoring instruments that measure an exact amount of air with a quantifiable number of viable microorganisms. Photo courtesy of Biotest Diagnostics.Click here to enlarge image

Swabs are used for sampling of uneven surfaces, such as tubing or equipment. Swabbing is qualitative and is technique-dependent. A 2 in2 x 2 in2 sample site is swabbed by using a back and forth technique and rotating 90° and repeating. The swabs are then streaked onto microbiological agar plates for identification.

Figure 2. Swabs are used for sampling of uneven surfaces, such as tubing or equipment. Photo courtesy of ITW Texwipe.Click here to enlarge image

Viable monitoring of personnel
Personnel working in a cleanroom also need to be monitored for microbial contamination. Personnel monitoring is an indication of gowning proficiency. Sampling sites are located on both gloves and gowns. Touch plates (contact plates) can be used to dynamically monitor technician’s hands immediately after a critical process.

Sampling

Sampling locations are selected based on many factors including potential product exposure areas, processing parameters, equipment design, and validation data. Frequency of monitoring depends on product and quality requirements, and sampling frequency changes should be based on trending analysis and changes in equipment, processing or personnel. A sampling plan describing procedures and identifying sample sites, sampling numbers, and sample frequency should be developed at every regulated company. Testing should be performed during static and dynamic situations.

Action/alert levels

Based on environmental monitoring data, companies must establish action levels, which describe the level of microbial contamination that triggers a planned sequence of corrective actions. The purpose of corrective actions is to return a facility to acceptable limits of viable microorganisms as quickly as possible. These actions will include a determination of what caused the viable counts to be above acceptable limits and how that will be rectified in the future. Exceeding the alert level should cause the company to increase sampling intensity or frequency in the affected area.

Conclusion

Overall, the EM program provides proactive feedback to the cleanliness of a manufacturing operation. It is a proven, effective measurement of quality levels for companies in regulated industries.

Bibliography

1. U.S. Pharmacopeia Convention, Inc. United States Pharmacopeia and National Formulary (USP-NF), 29th edition, Rockville, MD. (2004).

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Fran McAteer is vice president of quality at Microbiology Research Associates, Inc. (Acton, MA), an FDA-registered contract microbiology testing laboratory specializing in USP testing for pharmaceuticals, biologics, and medical devices. He has expertise and experience in EM programs and acts as a consultant for many companies. He can be reached via e-mail at [email protected].

Complicated market offers challenges, but overall growth prospects are encouraging

By Robert McIlvaine and Betty Tessien, The McIlvaine Company

Over the four decades of its existence, the cleanroom industry has been good to some investors and a disaster for others. Today the industry is still highly splintered despite the participation of a number of large international companies.

One problem is that the market is defined as a condition rather than a product or an application. Further, this condition is defined by the quantity of particles in the air. Granted, special gloves, garments, filters, walls, monitors, etc., are required for these conditions, but in general, the demands in the ultraclean sector are small compared to the general demands. In other words, the markets for cleanroom wipes and gloves are small compared to other uses such as in manufacturing and hospitals.

Merging similar-but-different technologies

Some years ago, U.S. Filter rolled up several hundred water filtration and treatment companies into a multibillion-dollar enterprise. This effort was built on expansion of a group of products, not a condition. Combining the manufacture of gloves and filters makes very little sense; rather it makes more sense to expand the geography and product varieties of gloves or filters.

Over the last decade a number of cleanroom companies have been acquired by public companies. In general, these companies have already been manufacturing compatible products for non-cleanroom applications.

One concept has been to integrate cleanroom air treatment technology into HVAC systems. Fedders Corporation was a leading example of this strategy. Its acquisition of Envirco, a major supplier of fan filter units and other cleanroom hardware, was followed by international expansion, including development of a good base in China. But for one reason or another, the strategy does not seem to have worked.

In July, Fedders Corporation announced that it had engaged The Blackstone Group to explore the possible sale of the company’s global indoor air quality (IAQ) businesses. It explained that the IAQ businesses were not core to the company’s principal global, residential and commercial HVAC businesses.

Included in the possible sale are the company’s North American IAQ production facility located in North Carolina, two factories in Suzhou, China, and sales offices located in the U.S., the U.K., Germany, China, Malaysia and India.

Fedders has had some rocky times and is appealing the decision by the New York Stock Exchange to suspend trading, beginning November 8, in its common and preferred stock, due to falling below its minimum market capitalization listing standards. Fedders common stock is now trading under the symbol FJCC and Fedders preferred stock under the symbol FJCCP.

Fedders also attempted to marry cleanroom air treatment with air pollution control. It acquired Trion, a major manufacturer of two-stage electrostatic precipitators utilized for in-plant air treatment as well as treatment of exhausts from light manufacturing. The would-be acquirers of the IAQ businesses will have to address whether this is a sound strategy.

Combining cleanroom air treatment and air pollution control does have a number of strengths. For example, the technology development is complementary. Also, the production needs are similar, allowing one factory to produce all the products. The end-user categories overlap somewhat, but the air pollution control systems are sold primarily to commercial restaurants, automobile manufacturers and others not associated with cleanrooms.

The Daikin acquisition of OYL from Hong Leong Group in late 2006 is another example of merging cleanroom technology with air pollution control and HVAC. At the offering, the purchase price was estimated at approximately 239 billion yen. American Air Filter (AAF), which is part of the OYL group, supplies complete engineered cleanroom systems as well as individual HEPA filters and even media for the capture of molecular contaminants.

AAF is a very large supplier of standard air pollution control products and competes with Trion (Fedders), but it also offers a much broader range of air treatment products. It has a number of manufacturing facilities in Asia, but the home office is in Kentucky.

Purafil, Inc. is a leading manufacturer of gas-phase air filtration systems designed to eliminate corrosive, hazardous, odorous and toxic gases. Purafil maintains nearly 20,000 installations worldwide. It is very active in the supply of gas-phase systems for airborne molecular contamination (AMC) elimination in semiconductor plants. Kaydon Corporation acquired the company in 2005.

Purafil has also been successful in selling its media for reducing odors from wastewater treatment plants. The technical challenge is similar to cleanrooms since odors are detectable by the human nose at the very low concentration levels found in cleanrooms.

Kaydon is a diversified manufacturer with a $1.2 billion capitalization. It supplies hydraulic and diesel oil filtration systems to a wide range of end users. But it is also a supplier of a number of unrelated products such as bearings and seals.

Consequently, three major suppliers of cleanroom air treatment products will have changed ownership in the last 24 months.

One very successful example of marrying cleanroom technology with air pollution control is the Donaldson Company. It makes absolute filters used in disk drives, as well as a number of other filtration products. It is also the world’s largest supplier of small air pollution control units. It has expanded vertically through the Tetratec division, which makes membrane media used not only by Donaldson but other filtration companies as well.

Smaller companies with more cleanroom leverage

For the investor, large companies such as Daikin and Kaydon offer relatively little opportunity to translate cleanroom success into stock appreciation. The cleanroom part of the business is just too small a percentage. However, there are some smaller companies whose cleanroom success will impact the bottom line.

Flanders is an example of a public company with cleanroom leverage. It is a vertically integrated company with nine filter assembly plants, two metalworking facilities and a paper mill among its thirteen operating sites. The company’s air filtration products are used in high-technology industries, including semiconductors, ultrapure material handling, biotechnology, pharmaceutical production, synthetics manufacturing and the containment of airborne radioactive particulates in nuclear facilities.

Flanders has a market capitalization of $270 million. Its growth is partially due to an acquisition in the retail filtration area. In the third quarter, it posted earnings of $6.2 million, or 24 cents a share, on revenue of $66.4 million compared with earnings of $3.7 million, or 14 cents a share, on revenue of $63.4 million for the same period last year. It has been trading on the NASDAQ for the last 10 years.

Cleanroom consumables

Cleanroom consumables are a multibillion-dollar world market. The problem is that most of the participants are large companies for which cleanrooms are only a small portion of the total.

For example, Kimberly Clark is a major supplier of cleanroom gloves and wipes, but this activity is minuscule compared to the total revenues of this international integrated manufacturer.

ITW Texwipe has plants in the U.S., Taiwan, Mexico and the Philippines. It supplies a complete array of wipers, swabs, mops, face masks, cleaning solutions and stationery for use in cleanroom environments. In 2001, Texwipe was acquired by Illinois Tool Works (ITW), which designs and produces an array of highly engineered fasteners and components, equipment and consumable systems, and specialty products and equipment. Its 700 decentralized business units in 48 countries employ nearly 50,000 people. So even though ITW Texwipe is one of the largest suppliers of cleanroom consumables, the impact on the corporation is small.

Cintas Corporation is enjoying increased revenues and profits. In the most recent quarter ending in September 2006, it reported revenue of $914.2 million, an 11 percent increase from the previous year’s first quarter revenue of $823.5 million. Net income of $85 million increased 8.3 percent from $78.4 million last year. Cintas expects fiscal 2007 to be another record year, which would result in its 38th consecutive year of growth in sales and earnings.

Cintas provides highly specialized services to businesses of all types throughout North America. The company designs, manufactures and implements corporate identity uniform programs, and provides entrance mats, restroom supplies, promotional products, first aid and safety products, fire protection services and document management services for approximately 700,000 businesses.

Cintas stocks more than 10,000 cleanroom products from 600 manufacturers and suppliers and is a significant player in laundering, processing and distribution in the cleanroom industry. Nevertheless, the impact of this activity on total profits for the company is minor.

Growth in Asia spurs acquisitions

The rapid growth of cleanroom markets in Asia will very likely spur a new round of acquisitions. Some companies, such as Hollingsworth & Vose and Ahlstrom, have expanded through investing in manufacturing facilities in China. Investment in this emerging market will curtail the growth of large Chinese competitors who would otherwise eventually be expanding internationally.

The automobile industry is a prime example of failure to invest in growing markets. After World War II, GM, Ford and Chrysler determined it was not worth the investment to manufacture vehicles with steering wheels on the right side and thus allowed Japanese vehicle manufacturers to grow in an uncontested market.

The lesson today is that, if you don’t establish a presence for your products in China, you will be creating a vacuum that will result in eventual increased competition in your established markets. This is particularly true of the cleanroom industry. The rapid growth of the semiconductor, flat-panel display and other cleanroom industries in China is bound to influence the international rankings of cleanroom suppliers.

One of the routes for growth will be acquisition of Chinese companies. There are some recent examples of this strategy by international investment funds and private investors. These companies will then be acquisition candidates.

In general, investment in the cleanroom industry will continue to be complicated. Nevertheless, the good growth prospects and high margins will make it worthwhile for investors to pursue opportunities.

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Robert McIlvaine is president and founder of The McIlvaine Company in Northfield, Illinois. The company first published Cleanrooms: World Markets in 1984 and has since continued to publish market and technical information for the cleanroom industry. He can be contacted at [email protected].

Betty Tessien is the cleanroom publications editor for The McIlvaine Company. She can be contacted at [email protected].