Preuse/Poststerilization Integrity Testing (PUPSIT): To Do or Not to Do?

References

1. 1.↵
   CBER/CDER/ORA. Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice. US Food and Drug Administration: Rockville, MD, 2004.
2. 2.↵
   Annex 1: Manufacture of sterile medicinal products. Volume 4: EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. European Commission: Brussels, 2008.
3. 3.↵
   1. Theodore H,
   2. Meltzer M. W,
   3. Jornitz

   . Filtration in the Biopharmaceutical Industry, Chapter 12. Sizing Microporous Membrane Filter Systems. Marcel Dekker Inc.: New York, 1998.
4. 4.↵
   1. Jornitz M.,
   2. Stering M.

   Pre-Use/Post-Sterilization Integrity Testing of Sterilizing Grade Filter - Is the Post-Use Test Sufficient. Am. Pharmaceut. Rev. 2017, 20 (5). https://www.americanpharmaceuticalreview.com/Featured-Articles/341190-Pre-Use-Post-Sterilization-Integrity-Testing-of-Sterilizing-Grade-Filter-Is-the-Post-Use-Test-Sufficient (accessed month date, year).
5. 5.↵
   Technical Report No. 26: Sterilizing Filtration of Liquids. Parenteral Drug Association: Bethesda, MD, 2008.