《4 - Use of PDA Technical Reports to Support Sterile r1》.pdf

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《4 - Use of PDA Technical Reports to Support Sterile r1》.pdf

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Use of PDA Technical Reports to Support Sterile and Aseptic Processing Practices Copyright Merck Millipore 2011. 1 Why PDA technical reports should be incorporated in sterile and aseptic process design Technical Report 26 - Sterilizing Filtration of Liquids – Overview key points Technical Report 40 - Sterilizing Filtration of Gases – Overview key points Copyright Merck Millipore 2011. 2 Why PDA technical reports should be incorporated in sterile and aseptic process design PDA is an international organization PDA technical reports gather experts from key organisations, companies, vendors, and regulatory agencies PDA documents are  public  regularly updated  Neutral and unbiased  comprehensive and include essential information  Used as reference documents by inspectors  Excellent value considering the wealth of information they contain Copyright Merck Millipore 2011. 3 PDA Technical Report 26 Sterilizing Filtration of Liquids Comments on 2007 Revision Copyright Merck Millipore 2011. 4 Scope of the New Edition PDA’s original Technical Report No. 26, Sterilizing Filtration of Liquids (1998) describes the use and validation of sterilizin