Current Practices in the Validation of Aseptic Processing

Current Practices in the Validation of Aseptic Processing

The validation of aseptic processing continues to be a major area of interest within the pharmaceutical indus-try. Five years have passed since the last PDA survey on this subject. While there have been no new broadly applicable regulations or regulatory guidance since that time, there has been continued controversy over the details of aseptic processing and process simulation practice. Industry practices largely adhere to current regulations and guidelines on aseptic processing by the European Union (1), ISO (2), and FDA (3). The impact of PDA’s TR #22 on “Process Simulation Testing for Aseptically Filled Products” (4) is also apparent.
Over time, industry methods, practices, and limits have been modified to adapt to the changing circumstances. The Pharmaceutical Manufacturers Association (now PhRMA) in 1979 (5) and PDA in 1986 (6), 1992 (7), and 1996 (8) conducted surveys on this subject that have provided a clearer understanding of contemporary industry practice. This survey addresses the continu-ing need to track industry practices in the validation of aseptic processing as it evolves. 
Questionnaires were sent to eighty-eight (88) firms that specifically agreed to participate with PDA in this effort. Forty-three (43) responses were received representing both US and overseas locations. The re-sults were tabulated to provide both raw numerical and percentage of total respondents. Where the respondents provided comments (whether solicited or given volun-tarily), these comments are provided after the question. Where more than one respondent provided essentially the same response selection and comment, they have been consolidated and a number appears next to the response indicating the number of comments of that type. The nature and extent of the comments received were extensive, and for this reason, the authors have chosen to combine similar responses. One of the major benefits of surveying on a regular basis is the opportu-nity to follow the evolution of concepts and practices over time. To that end, this survey instrument used many questions that were nearly identical to those asked in 1992 and 1996. 


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