Pharmaceutical Industry StandardsPharmaceutical Cleanrooms are usually 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 the following:
- Pressurization Control
- Elimination of Cross Contamination
- Filtration of Outdoor & Indoor Air
Medical Device StandardsThe main objective of a medical device clean room is to eliminate surface contamination (viable particulate) on their products. 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. Important elements to consider, include:
- Contaminant Levels
CAP 18 Pass-Thru - CAP18W wall-mounted single door pass-thru cabinets are strong, durable, easily cleaned and provide a superior look to your cleanroom setting. Wall-mounted pass-thru cabinets allow products to enter a cleanroom without human traffic, decreasing the particle loads as well as the amount of time it takes to transport products safely. Floor-mounted single door pass-thrus accommodate large components and carts. Clean Air Products offers a variety of designs with a wide range of options customizable for your specific industry needs.
Clean BenchesLaminar flow clean benches create free-standing micro-environments.
Clean Air Products offers a range of both horizontal and vertical laminar flow benches, plus the expertise to ensure you get the best product for your needs. All of Clean Air’s clean benches are equipped with HEPA filters to provide Class 100 (ISO 5) working environments and are pre-assembled and ready for operation.
CAP 412 Mode WO - CAP 412 mode WO vertical laminar-flow clean benches are available in a variety of sizes and styles engineered to provide excellent solutions for air filtration applications. They can be used in conjunction with cleanrooms to create clean zones or used in place of high-class cleanrooms to provide a more cost-efficient but equally clean environment. Vertical laminar flow clean benches are compressed and allow more space for additional clean benches and cleanroom equipment. They are ideal for compounding pharmacies.
CAP 201 Horizontal Laminar Flow Clean Bench - CAP201 horizontal laminar flow clean benches allow for wider workspaces than vertical benches and feature Vinclad steel or painted structural materials for the ultimate in appearance and resistance. The efficient design minimizes weight and space. The cabinet configuration has been designed for “clean” edge air-shear of the absolute filter, thus assuring clean laminar airflow through the work area by eliminating turbulence and back currents.