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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 ÈÎÎñ¸ü»»£¬Èç¹ûÕÒ²»µ½ÉÏÊöÎÄÏ×£¬ÕÒµ½ÕâЩÎÄÏ×Ò²ÊÇ¿ÉÒԵġ£ лл [ Last edited by the810 on 2009-8-30 at 11:38 ] |
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