Research ArticleRESEARCH

How and Why Would You Do a Pressure Holding Test on an Aseptic Installation for which You Want to Check the Integrity? Theory and Practical Example

Olivier Chancel, Raoul Grissely, Magnus Stering and Luc Pisarik
PDA Journal of Pharmaceutical Science and Technology January 2010, 64 (1) 71-79;

References

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    1. Sharnez R.,
    2. Stianchi R.,
    3. Stannard M.,
    4. Yegneswaran P. K.
    Microbial ingress through breaches in aseptic manufacturing systems: experimental investigation of pressure-driven leaks of liquids. PDA J. Pharm. Sci. Technol. 2007, 61 ( 3), 154– 159.
    OpenUrlAbstract/FREE Full Text
  2. 2.↵
    1. Newman R.
    Time-out for hold time validations. PDA Letter 2006, XLII ( 7), 20– 22.
    OpenUrl
  3. 3.↵
    Pharmaceutical Inspection Co-operation Scheme. Recommendation on the validation of aseptic processes. Pharmaceutical Inspection Convention 2004, PI007-2, 4.
    OpenUrl
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How and Why Would You Do a Pressure Holding Test on an Aseptic Installation for which You Want to Check the Integrity? Theory and Practical Example
Olivier Chancel, Raoul Grissely, Magnus Stering, Luc Pisarik
PDA Journal of Pharmaceutical Science and Technology Jan 2010, 64 (1) 71-79;
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