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

Vivek Sheel Gupta1, Jitendra Jindal2, Ashawant Gupta2

  • 1Advanced Microdevices Pvt. Ltd. (MDI), Ambala Cantt, India vsg@mdimembrane.com.

PDA Journal of Pharmaceutical Science and Technology
|November 17, 2019
PubMed
Summary
This summary is machine-generated.

Filter clogging can falsely indicate a sterilizing filter is integral, potentially compromising drug product safety. Preuse/poststerilization integrity testing (PUPSIT) is crucial for certain drug products to ensure filter integrity and downstream sterility.

Keywords:
Bubble pointFilter validationPUPSITPostuse integrity testingPreuse integrity testSpecific drug product validationSterile drug productsSterilizing grade filters

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Area of Science:

  • Pharmaceutical Manufacturing
  • Filtration Technology
  • Sterile Drug Production

Background:

  • Sterilizing grade filters are critical for heat-labile drug products.
  • Filter integrity testing, particularly postuse, is mandated by regulatory bodies.
  • Preuse/poststerilization integrity testing (PUPSIT) presents risks and costs.

Purpose of the Study:

  • To investigate the impact of filter clogging on bubble point test values.
  • To assess the risk of non-integral filters passing postuse integrity tests.
  • To determine the necessity of PUPSIT based on filter performance.

Main Methods:

  • Evaluated 0.2 μm sterilizing filters from four manufacturers.
  • Tested fluid streams with varying clogging propensities (dextrose, bentonite, paclitaxel, sodium hyaluronate).
  • Compared preuse and postuse bubble point values.

Main Results:

  • Filter clogging significantly increased postuse bubble point values.
  • Increased values can mask a non-integral filter.
  • Observed substantial postfiltration shifts in bubble point for certain fluid streams.

Conclusions:

  • Filter clogging can lead to a false sense of security regarding filter integrity.
  • The necessity of PUPSIT should be evaluated case-by-case based on postfiltration bubble point shifts.
  • Further filter validation studies are needed to establish PUPSIT requirements for specific drug products.