PUPSIT Filtration in Single-Use Assemblies

Ensuring process integrity, compliance and flexibility in aseptic manufacturing

Ensure Ultimate Sterility Assurance with PUPSIT-Compliant Filtration

In today’s pharmaceutical manufacturing, patient safety and product quality are non-negotiable.

That’s why leading manufacturers trust Pre-Use Post Sterilisation Integrity Testing (PUPSIT) as a critical step in their sterile filtration processes. Especially when it’s not possible to sterilize the product in their final container(s). 

 

What is PUPSIT?

PUPSIT is the gold standard for verifying the integrity of sterilising-grade filters immediately before use. By performing a validated, non-destructive integrity test after filter sterilisation and before product filtration, manufacturers can confidently rule out filter damage or integrity loss—ensuring that only truly sterile product reaches the patient.

Animated PUPSIT

Watch how PUPSIT filtration protects your process

Pupsit Animation

Explore how Pre-Use Post Sterilisation Integrity Testing (PUPSIT) can be seamlessly integrated into your single-use assembly. This animation shows the basic working principle of a PUPSIT-ready design — supporting aseptic processing and full compliance with EU GMP Annex 1. At UltraPure International, we specialise in custom-engineered single-use systems that ensure filtration integrity, reduce contamination risk, and meet strict regulatory requirements. Every PUPSIT solution is tailored to your process and supported by our expert team and trusted sales partners. Want to learn more about PUPSIT integration or start designing your own solution? Visit our website: www.ultrapure-international.com Or contact us directly: info@ultrapure-international.com Note: This animation is a visual representation only. Final designs are always customer-specific and confidential.

Why is PUPSIT Essential?

While PUPSIT is the preferred approach, we understand that some processes present unique challenges. In such cases, our solutions include comprehensive risk assessments and alternative controls, always in line with regulatory expectations.

In the fast-evolving world of sterile pharmaceutical manufacturing, compliance with the latest EU GMP Annex 1 requirements is essential. UltraPure International is your trusted partner for single-use PUPSIT (Pre-Use Post Sterilisation Integrity Testing) assemblies, ensuring your filtration processes are robust, reliable, and fully regulatory compliant.

  • Regulatory Compliance: PUPSIT is a requirement under the latest EU GMP Annex 1 guidelines for sterile medicinal products.
  • Risk Mitigation: It provides robust assurance that the filter has not been compromised during sterilisation, handling, or installation.
  • Patient Safety: By confirming filter integrity, PUPSIT helps prevent microbial contamination and upholds the highest standards of product sterility.

Why Choose UltraPure International for Your Single-Use PUPSIT Needs?

Turnkey PUPSIT solutions

UltraPure International designs and delivers fully integrated single-use assemblies that enable seamless pre-use post-sterilisation integrity testing. Our systems are engineered for compatibility with leading filter brands, due to our open architecture, and can be customized to your process requirements.

Regulatory confidence

Our assemblies are developed in line with EU GMP Annex 1 guidelines, supporting both pre-use and post-use integrity testing for every batch. We help you meet and document all regulatory expectations, minimizing compliance risks.

Flexible & scalable

Whether you need one specific PUPSIT assembly or custom assemblies for each batch, UltraPure International’s modular approach adapts to your batch size, product type, and facility layout.

Expert support

Our technical team guides you from design through implementation, including risk assessments.

Technical excellence

UltraPure International’s single-use PUPSIT assemblies feature: 

  • Closed-system design to minimize contamination risk
  • Optimized flow paths and minimal aseptic connections
  • Full traceability and documentation for every component

What does a PUPSIT-ready single-use assembly typically look like?

UltraPure International does not offer off-the-shelf designs.

However, we do provide general visual representations to support early-stage discussions. These include schematic layouts and example Bills of Materials to help you understand what is possible. 

How can I get started with a custom PUPSIT solution?

If your process requires filter integrity testing in line with Annex 1, or if you are exploring ways to improve filtration control within your single-use systems, UltraPure International is ready to support you.

Interested? Get in touch with our team and we’ll connect you with the right partner for your region and application. We work closely together to ensure smooth communication, expert support, and reliable delivery. 

 

Frequently asked questions (FAQ)
  • Is PUPSIT always required under Annex 1?

    PUPSIT is mandated by EU GMP Annex 1 (Section 8.87) for all sterile filtration processes, unless a thorough risk assessment justifies an alternative approach.

    PUPSIT is mandated by EU GMP Annex 1 (Section 8.87) for all sterile filtration processes, unless a thorough risk assessment justifies an alternative approach.

    If PUPSIT is not feasible (e.g., due to very small batch sizes), a comprehensive risk assessment and additional controls must be implemented, including:

    • Detailed knowledge and control of the filter sterilisation process.
    • Secure supply chain management, including validated transport and packaging.
    • In-depth process knowledge to ensure no impact on filter integrity or test values.
  • Can UltraPure International adapt PUPSIT integration to my existing process?

    Yes. All assemblies are designed to fit your specific layout and operational needs.

    Yes. All assemblies are designed to fit your specific layout and operational needs.

  • Do you offer support with validation and documentation?

    Yes. We help you meet and document all regulatory expectations, minimizing compliance risks.

    Yes. We help you meet and document all regulatory expectations, minimizing compliance risks.

  • Are designs and layouts kept confidential?

    Yes. UltraPure International maintains full confidentiality for every customer-specific solution.

    Yes. UltraPure International maintains full confidentiality for every customer-specific solution.