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Sterility Assurance: The Ultimate Move Against Risk
2026-02-28
In the world of aseptic processing, every step is a strategic move against contamination. Among them, PUPSIT (Pre-Use Post-Sterilization Integrity Testing) stands as one of the most critical "chess pieces" in your sterility assurance strategy.
📖 Terminology Spotlight: What is PUPSIT?
It is the gold standard for proving a filter is intact at the exact moment of use.
- Pre-Use: Conducted before product filtration begins.
- Post-Sterilization: Performed after the filter has completed its final sterilization cycle (SIP, autoclave, or irradiation).
- Integrity Testing: A physical confirmation of the filter's barrier strength.
The "Why": This specific timing is designed to capture any damage that the sterilization process itself might have caused to the filter.
🌍 The Global Regulatory Standard
Navigating PUPSIT isn't just about best practices; it's about meeting high-stakes global expectations:
- EMA Annex 1 (2022): Implementation is the default expectation. Any omission requires a rigorous, evidence-based justification.
- PDA TR 26 (2025 Revision): Provides the scientific bridge for modern risk-based compliance pathways.
- FDA Guidance: Underlines the extreme importance of integrity testing to the entire sterility assurance framework.
🛠️ Our Role: Your Data & Compliance Partner
We don't just supply filters; we help you build a robust "Risk Isolation Wall":
- Validation "Ammunition": We provide technical documentation aligned with PDA TR 26 to support your risk assessments.
- Customized Strategies: For complex setups like Single-Use Systems (SUS), we co-design "Equivalent Control" validation studies.
- Future proofing: We help you interpret upcoming regulatory shifts to keep your processes ahead of the curve.
🧩 When Reality Hits: The Decision Roadmap
Not every process is a "comfort zone" for PUPSIT. While classic biopharma systems often favor strict execution, innovative therapies (like CAR-T) may require Equivalent Assurance paths involving deep data, supply chain control, and redundant filtration.
The Bottom Line: PUPSIT is the "Gold Standard" for patient safety. Whether you follow the standard path or build a validated alternative, commitment to the patient remains unchanged.
Is your process ready for the next regulatory audit? As your data and compliance partner, we provide the validation "ammunition" and technical expertise to help you build a robust risk assessment.
Would you like me to provide a summarized checklist of the "Compensatory Control Strategies" mentioned in the PDA TR 26 guidelines?
#Biotech #PharmaManufacturing #SterilityAssurance #PUPSIT #QualityCompliance #AsepticProcessing
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