Aseptic Processing: Keeping it Safe
Humans represent the greatest risk for microbial contamination in an aseptic process.
BioPharm International 1/7/2015
submitted by Dr Syed Ibrahim Ismail
Aseptic processing has garnered some increased scrutiny from FDA in recent years, primarily because it is considered a high-risk activity by the agency, says Rainer Newman, consultant at Aseptic Process Technology, LLC. In addition, says Satish Singh, research fellow and group leader at Pfizer, “Microbiologically-related recalls have always been a significant portion of the enforcement actions by FDA.” In fact, more than 75% of FDA recalls during 2004–2011 involved sterile products, and approximately 80% of these recalls were linked to “lack of sterility assurance.” Many of the remaining 20% of recalls were attributed to microbial contamination or a failed fill/finish product test (1). Although packaging failures factored into a majority of the “lack of sterility assurance” cases, many of the remaining contamination cases were associated with GMP issues or manufacturing errors such as incomplete sterilization or nonsterile components being added to sterile products (1).
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