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Validation of Tangential Flow Filtration in Biopharmaceutical Applications
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PS Technical Monograph No.3 (1992) The Prevention and Detection of Leaks in Ampoules, Vials and Other Parenteral Containers
PS Technical Monograph No.4 (1993) The Use of Process Simulation Tests in the Evaluation of Processes for the Manufacture of Sterile Products
PS Technical Monograph No.5 (1994) Sterilisation of Freeze Dryers
PS Technical Monograph No.6 (1994) Guideline on Limulus Amoebocyte Lysate Testing
PS Technical Monograph No.7 (1995) Leak Testing of Freeze Dryers
PHSS Technical Monograph No.8 (revised 2008 ) Integrity Testing of Freeze Dryer Inlet Filters
PS Technical Monograph No.9 (1997) Specification & Validation of Freeze Dryers
PS Technical Monograph No.10 (1998) Introduction to Pharmaceutical Freeze Drying
PS Technical Monograph No.11 (1999) Steam Sterilisation Validation
PS Technical Monograph No.12 (2003) Refrigeration in Freeze Dryers
PS Technical Monograph No.14 (2005) Risk Management of Contamination (RMC) During Manufacturing Operations in Cleanrooms
PHSS - Pharmaceutical Sterile Product GMP Auditing Manual Pharmaceutical Sterile Product GMP Auditing Manual
PHSS Technical Monograph No.2 (revised 2002) Environmental Contamination Control Practice REVISED 2002
PHSS Technical Monograph No.13 (2007) The Cleaning of Freeze Dryers
PHSS Technical Monograph No.16 (2008) Best Practice for Particle Monitoring in Pharmaceutical Facilities


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[ Last edited by the810 on 2009-8-30 at 11:38 ]
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[ Last edited by wnting on 2009-7-26 at 16:36 ]
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