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Are restricted access barrier systems (RABS) and isolators replacing traditional cleanrooms? All have the same aseptic requirements, but some argue that isolators and RABS increase asepsis. Many companies, especially large pharmaceuticals, are making the switch from cleanrooms to RABS or isolators. But others remain leery of these relatively new technologies. The first isolators of the early 90s fell short of expectations, leading to the development of RABS as an alternative.
Arguably, one of the most promising areas in the healthcare sector is biologics. Biologics-based products and combination products appeal to some pharmaceutical firms not just for their treatment potential, but for their financial prospects, and for their ability to extend patent protection. “There is a lot more patent protection around these [biologics] molecules,” says Robert Smith, a director at Genzyme in the U.K. “Proteins and biologics are larger molecules than typical drugs."
The risk of contamination can be minimized within a packaging operation by the implementation of architectural, engineering and procedural modifications. Here are some areas to consider in the risk evaluation:
Personnel (21CFR211.28(a)) – The personnel in the primary packaging operation must be protected to limit exposure to the product. The use of personal protection, gowning and procedures can limit the risk of exposure.
Operations – The complexity of the packaging process and the use of automation can affect the risk of contamination. The risk is minimal if the product is not exposed to the environment during the packaging process (Equipment 21CFR211.65). If the product is exposed to the environment during the packaging, contamination can be caused by foreign material. Cleaning procedures can help reduce the risk of contamination by foreign material.
