Transcription of PDA Technical Report #26 - IKEV
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PDA Technical Report #26 - IKEV
PDA. PDA Technical Technical Report Report #26: #26: Implications Implications on on Liquid Liquid Filter Filter Validation Validation Maik W. Jornitz, Sartorius Corp. , May 2002. Filter Qualification Tests for internal Validation Guides Physical Tests Tests according to USP 24. flow rates/delta p particle realease (asbestos throughput release). steam sterilizability extractable substances/heavy pressure and temperature metals resistance oxidizable substances autoclavibility biosafety endotoxin Biological Tests integrity test correlation to Extractables Tests bacteria retention extractable analysis with NVR. bubble point diffusion bacteria retention after 1/20 steam cycles , May 2002. FDA Regulatory Requirements PDA Special Scientific Forum, Bethesda, MD; Validation of Microbial Retention of Sterilizing Filters, July 12 13, 1995. Validation of filters should include microbiological challenges according to ASTM. F838- 83. Challenge conditions should simulate "worst case" production conditions (pH, temp.)
M.W.Jornitz, May 2002 FDA Regulatory Requirements PDA Special Scientific Forum, Bethesda, MD; Validation of Microbial Retention of Sterilizing Filters, July 12 – 13,
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