BioPhorum 2024 post sterilization pre-use integrity testing (PUPSIT) practice in the biopharmaceutical industry survey findings
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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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Single-use solutions for PUPSIT: requirements, challenges, and solutions
Glenz, M., Eiermann, P., Manser, B., & Teschner, H. (2026) · Applied Microbiology and Biotechnology · doi:10.1007/s00253-026-13847-5 · Cited by 1 · see citing works
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- BioPhorum
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- BioPhorum
- Published
- 2024-10-30
- Cited by
- 1
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- 0
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