Cited by 1

BioPhorum 2024 post sterilization pre-use integrity testing (PUPSIT) practice in the biopharmaceutical industry survey findings

BioPhorum·2024

Integrity signals

Registry

Crossref · 10.46220/2024ff002

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  • Industry feedback highlighted concerns with PUPSIT complexities including system design, reliable filter wetting, and increased risk of human error.

    “Industry feedback highlighted concerns with these complexities including system design, reliable filter wetting, and the increased risk of human error in the more intricate PUPSIT process (BioPhorum Operations Group (BPOG), 2024).”

    From Single-use solutions for PUPSIT: requirements, challenges, and solutions (2026) · cites this paper as BioPhorum Operations Group (BPOG), 2024

  • Additional connections for PUPSIT operations can bring extra risks of dead legs, hold-up volume, or non-conformities, especially on the sterile downstream side of a filter.

    “The additional connections for these operations can bring extra risks of dead legs, hold-up volume, or non-conformities, which present a risk especially on the sterile downstream side of a filter.”

    From Single-use solutions for PUPSIT: requirements, challenges, and solutions (2026) · cites this paper as BioPhorum Operations Group (BPOG), 2024

  • Implementing PUPSIT introduces significant technical and operational challenges, including more complex wetting and venting procedures that may bring increased risk of contamination and susceptibility to human error.

    “However, implementing PUPSIT introduces significant technical and operational challenges, including more complex wetting and venting procedures that may bring increased risk of contamination and susceptibility to human error.”

    From Single-use solutions for PUPSIT: requirements, challenges, and solutions (2026) · cites this paper as BioPhorum Operations Group (BPOG), 2024

  • Implementing PUPSIT is not without considerable technical and operational challenges, as a survey of drug manufacturers by BioPhorum Operations Group in 2024 shows.

    “Implementing PUPSIT is not without considerable technical and operational challenges, as a survey of drug manufacturers by BioPhorum Operations Group in 2024 shows:”

    From Single-use solutions for PUPSIT: requirements, challenges, and solutions (2026) · cites this paper as BioPhorum Operations Group (BPOG), 2024

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Authors
BioPhorum
Publisher
BioPhorum
Published
2024-10-30
Cited by
1
References
0

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