Biotechnology, Biopharmaceutical, and Pharmaceutical Cleanrooms
Many Biotechnology and Pharmaceutical Cleanrooms are specified at ISO Class 5 to ISO Class 8 and apply to many cleanroom standards. Particulate is a concern however, specifically, viable particulate contamination, the ability to keep the room clean typically using modular or stick built components with integral cove bases, cove corners, and coved ceilings to maintain a cleanable surface condition is crucial under cleanroom standards. Biotech and Pharmaceutical cleanrooms tend to be sanitized in different ways, and different products are applicable depending on the sanitization methods employed. Concealed areas for bacterial growth are unacceptable. These rooms typically use cleanroom technology that keeps the seal unbroken during sanitation and filter changes. Biotechnology and Pharmaceutical cleanrooms typically focus heavily on pressurization control, elimination of cross contamination and filtration of outdoor air and indoor air.
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For those processes that do not require certified cleanrooms, clean environments are typically created with air flows and cleanliness levels above class 100,000. These rooms are sometimes called white rooms and involve the creation of clean space with non-particulating surfaces similar to a cleanroom, but with typically reduced air flow and filtration requirements. Some products which have been manufactured in a warehouse environment such as plastic molding injections for food and drug enclosures, plastic extrusions for medical devices and many other items, have moved toward clean environments and white rooms for their processes.
The clean environments and white rooms tend to reduce defect rate and surface contamination without adding excessive capital costs. The cleanliness level typically does not have to be greater as the defect rate will not be affected in an even cleaner cleanroom environment. Because of the nature of today’s business, suppliers furnishing products to pharmaceutical, biotech and other companies find themselves having the cleanliness levels increased on their manufacturing processes from where they were years ago. This is so that the customer they supply can provide a verifiably clean product.
Optic/Defense Industry Cleanrooms
The Optics and Defense industries use cleanrooms for many applications. Some similar to Microelectronic, some similar to Biotech and Pharmaceutical, and some to Medical Device. Applications range from chip making for controlling missiles, radar and electronic components, to the development of lasers for guidance systems and biological components for vaccines and test agents. These cleanroom enviorments typically fall into one of the categories listed above, however they also tend to require high security and closure. Because of the sensitivity of various programs, this typically leads to the stick-built approach in many Defense Industry cleanrooms to allow for the perimeter to meet government security requirements.
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Medical Device Cleanrooms
Medical Device Cleanrooms are typically built under the cleanroom classifications ISO Class 7 and ISO Class 8 range. The manufacturing process of these products ensures that the surface of the product does not have particulate contamination when completed. The Typical medical device process includes final packaging of the product for use to an end user. It is important that cleanliness level be maintained both from a cleanroom stand point and a personnel protocol standpoint. People are the major contaminator in most processes. In fact, pharmaceutical, biotech and microelectronics industries require full gowns, booties, gloves, and hairnets. Medical device cleanrooms may not have such stringent gowning practices as Pharmaceutical cleanrooms, but protocol and cleaning are equally important. The cleanroom environment for medical devices usually aims to eliminate surface contamination (viable particulate) on their products.
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- Filtrona Extrusion Cleanroom Expansion, Athol, MA
- EMD Millipore Mobius II, Danvers, MA
- EMD Millipore Mobius III, Danvers, MA
- CR Bard, Queensbury, NY
- Surmasis, Des Moines, IA
- Integra Companies, Devens, MA
- Phase 2 Medical, Rochester, NH
- Trelleborg AB Sealing Solutions, Northborough, MA
Nanotech and Microelectronic cleanrooms are designed to maintain temperature, humidity, particulate, static and pressure levels. Typically, temperature and humidity as well as particulates and static can directly affect the final product. Since defects in the process can occur at any stage, the cleanliness level of the cleanroom environment must be maintained on a constant basis. Since many steps are involved in order to come to a final product, a defect along the way is not discovered until the end. It can be very costly if the cleanroom does not operate properly. Most of these cleanrooms operate in a cleanroom classification range from ISO Class 1 to ISO Class 6 with various processes occurring at different levels of cleanliness.
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The automotive industry has come a long way in their manufacturing processes, particularly with the wide range of attention given to mass defects. Like many other industries, the need for manufacturing auto components inside cleanrooms has become pronounced. Pressure, temperature and humidity are just as important to these rooms, like others that are typically designed in the cleanroom classification range of ISO 7 and ISO 8. The defects that can occur in automotive are vast, including glass coatings, electrical components, and painting.
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