Tag Archives: Clean Rooms

Compiled by Carrie Meadows

Minienvironments and isolation equipment play an important role in reducing contamination through exposure to airborne particles and human contact. Developers of enclosures and accompanying workstation equipment must not only focus on the cleanliness of the atmosphere but also keep in mind how the design will affect user experience and safety.

Horizontal laminar flow clean bench

The Series 303 horizontal laminar flow clean bench is a general-purpose unit that provides a Class 100 or Class 10 clean air environment suitable for laboratory work, testing, manufacturing, inspection, or pharmaceutical operations. The cabinets are designed for quiet operation; sound levels vary depending on the size of the unit. HEPA filters provide horizontal laminar flow air that washes out particulates and prevents contamination from entering the clean work zone. Options include a removable, perforated HEPA filter protective grill, a safety glass hood, an extended hood (no built-in table), and ultraviolet germicidal lamps.

Clean Air Products
Minneapolis, MN
www.cleanairproducts.com

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New Products


February 1, 2009

Compiled by Carrie Meadows

Cleanroom pass-through chambers

BioSafeTM pass-through chambers meet requirements for clean, aseptic processing in biotech, pharmaceutical, medical device, and other critical applications. The 304/316 electropolished stainless-steel pass-throughs feature a seamless design with coved corners and ultrasmooth surfaces that eliminates cracks, corners, and other contaminant traps. A rugged, high-reliability mechanical interlock

By Sarah Fister Gale

The 2008 death of six infants in China due to melamine poisoning spurred international outrage and increasing concern about shortcomings in global food-safety monitoring strategies.

The melamine contamination occurred when milk producers in China attempted to up the protein value of watered-down products by adding the industrial chemical melamine to the milk supply. The contaminant ended up sickening hundreds of thousands of babies across the country. Within weeks, the toxin was identified in dozens of products, from infant formula and yogurt to candies and drink powders; and traces of melamine were found in goods sold as far away as Europe and the U.S.

The incident forced government agencies in China and around the world to re-evaluate their food testing regulations. And it set off a scramble to find a method that could quickly and accurately identify this potentially lethal chemical in the food supply.

Two U.S. teams responded with test methods that can quickly and effectively detect levels of melamine contamination in the milk supply.

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By Hank Hogan

A growing number of companies are seeking buyers for surplus semiconductor wafer-processing gear. At the same time, others have to replace or change tools. The former’s plight could be a windfall for the latter.

However, reaping that benefit takes work, with attention to equipment decontamination, decommissioning, and refurbishing. Gary Alexander was executive director of the Surplus Equipment Consortium Network, or SEC/N, before its acquisition late last year by the trade organization SEMI (San Jose, CA). He notes that secondary equipment transactions are complicated, a fact often overlooked.

“For the most part, companies historically have tended to underestimate the importance and challenges associated with buying and selling secondhand equipment,” says Alexander.

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Interphex 2009


February 1, 2009

Exhibitor showcase

Pharmaceutical and biotech companies from all over will display their latest innovations at INTERPHEX 2009, offering contamination control technologies in the manufacturing, IT, and facilities segments.

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Saving green by being green


February 1, 2009

By Bruce Flickinger

Today’s chip fabricators
seek a balance between cost- and energy-conscious solutions.

There is a lot of talk these days in the chip fabrication community about energy efficiency, resource management, and sustainable operations

By Alan Wood, Novapak Corp.

Maintaining the high purity of chemicals during filling and packaging reduces the risk of contamination in semiconductor processes.

In semiconductor manufacturing, contaminants in minute amounts can have devastating effects on microcircuits and, in turn, on the bottom line. Chemicals can be used to remove traces of organics, metals, oxide residues, and other contaminants but are themselves a potential source of contamination. Therefore, maintaining high purity throughout the filling and packaging of these chemicals is critical. The process must begin with a container that is free of contaminants. “Using an ultraclean container ensures the purity of formulations and demonstrates to customers that we are committed to maintaining the quality of our product,” explains Lou DiRenzo, president of Puritan Products (Bethlehem, PA), a supplier of chemicals for the semiconductor and laboratory industries.

Glass has long been the standard for packaging electronic and laboratory chemicals, yet not without sacrifice. Compared to a high-quality plastic, such as high-density polyethylene (HDPE), glass is 9 to 11 times heavier and therefore more costly to transport. Also, the breakability of glass bottles can result in product loss and potential health risks. Glass bottles are frequently coated in polyvinyl chloride (PVC)

Getting the bugs out


February 1, 2009

By Tanja Bogicevic, Biotest Diagnostics Corp.

What will the next generation of media for cleanrooms bring?

The advanced bio/pharmaceutical manufacturing world encompasses the development of sophisticated drug products and lifesaving medical devices, which places an unprecedented amount of importance on safety and accuracy. Pharmaceutical, biotech, and medical device industries are striving now more than ever to ensure the highest integrity of their products through precise production platforms. These platforms begin at the early stages of product development and extend through each developmental step, ultimately ending in the release of a finished product.

Perhaps the most critical step in a product’s developmental lifecycle is ensuring a clean and controlled environment with little to no microbial presence. A microbial environment within specifications will help achieve the successful launch of a product to market. The presence of microbes above the allowable limits can result in wholly undesirable effects such as product sterility failure, product recall, or potential legal implications. Therefore, ensuring the correct level of control is of utmost importance during the production of a product within a clean environment.

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By Jim Polarine, Jr., John Macauley, Peter Karanja, Dan Klein, and Abigail Martin, STERIS Corp.

Choose an antimicrobial chemistry that addresses mold isolates specific to your cleanroom operations.

In pharmaceutical, biotech, and medical device cleanrooms there is increasing incidence of mold growth, a situation that can lead to environmental monitoring excursions and operation suspensions. Although a facility shutdown is the worst case, frequent isolation of fungi within a cleanroom can indicate a potential reservoir of contamination that can cause ongoing long-term problems.

Many pharmaceutical and biotech companies face challenges in setting acceptable limits for molds in their cleanroom operations. Although a zero limit is unrealistic, the tendency is to set very low levels for molds in most operations in order to minimize future challenges. To keep mold growth below these aggressive target levels, it is essential to choose disinfectants that demonstrate excellent activity against common cleanroom fungi. Fungal spores, like bacterial spores, can present a significant challenge to many commonly used disinfectants. This article presents an overview of common contamination control examples and provides a study of the activity of several disinfectants and sporicides against common fungi found in pharmaceutical, biotech, and medical device cleanroom operations.

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