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.
Facility (21CFR211.42(b)) – When multiple products are packaged in the same facility, contamination can be caused by other products. The use of airlocks, increased ventilation, and air filtration can decrease the risk of cross-contamination (Ventilation, air filtration, air conditioning and cooling 21CFR211.46(c)).
The potential for contamination should be evaluated and suitable methods identified and implemented to minimize the risks to the finished product and the packaging personnel.
For more information, see the Code of Federal Regulations.
--By Linda McBride, registered pharmacist
Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread and Novartis Consumer Health. She holds a B.S. in pharmacy and is a member of the International Society for Pharmaceutical Engineering and the Regulatory Affairs Professionals Society.
