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

References

1. 1.↵
   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.

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2. 2.↵
   1. Newman R.

   Time-out for hold time validations. PDA Letter 2006, XLII ( 7), 20– 22.

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3. 3.↵
   Pharmaceutical Inspection Co-operation Scheme. Recommendation on the validation of aseptic processes. Pharmaceutical Inspection Convention 2004, PI007-2, 4.

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