• Image of RoSS.PPST, an automated single-use PUPSIT (pre-use post sterilization integrity testing) system by Single Use Support.

PUPSIT system | RoSS.PPST

PUPSIT system | RoSS.PPST

RoSS.PPST is an advanced PUPSIT system that tests the integrity of up to two filters used in biopharmaceutical manufacturing. It verifies filter integrity after sterilisation and prior to aliquotation, meeting EU GMP Annex 1 relevant quality standards. With intuitive operator guidance and real-time monitoring of pressure and flow, RoSS.PPST minimizes the risk of errors and contamination.

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100% customizable
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Fully automated
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GMP Annex 1 compatible
A close-up image of an operator handling an aseptic filling system for single-use bags.

Features and benefits of our PUPSIT solution

  • Standard configuration: Available as standard version with the option to test two filters
  • Compatible with all common product filters
  • User-friendly workflow
  • Suitable for cleanroom and GMP-compliant construction
  • Seamless integration into end-to-end solutions from Single Use Support
  • Additional products and services available including single-use assemblies for PUPSIT

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What makes RoSS.PPST the optimal PUPSIT system?

  • Customizable setup

    Aseptic processes vary - so should your PUPSIT solution. Our fully customizable PUPSIT skid adapts to specific filter integrity testing needs, offering flexible PUPSIT assembly options. We collaborate closely with customers to deliver tailored, process-ready systems.

  • Simple & seamless integration

    The PUPSIT rack seamlessly connects with our innovative RoSS.FILL system, enabling a fully automated aliquotation process in sterile manufacturing. Alternatively, RoSS.PPST can operate as a standalone platform. 

  • Prevent product loss

    Our automated single-use PUPSIT (pre-use post sterilization integrity testing) solution detects filter issues, helping to maintain product quality, prevent contamination, and avoid costly product losses.

  • GMP-compliant

    Our sterile filtration system in the pharmaceutical industry is fully compliant with EU GMP Annex 1 and global regulations - designed to prevent microscopic flaws that could risk product quality or patient safety.
Graphic of a single-use filter assembly, FIL-01.

Your filter single-use assemblies

We offer manufacturer-independent single-use PUPSIT assemblies, designed and delivered to meet individual process requirements.

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Downloads

Preview of RoSS.PPST datasheet
Datasheet: RoSS.PPST
Preview of RoSS.PPST datasheet
Datasheet: RoSS.PPST
 

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More information

Annex 1 and the PUPSIT requirement

Annex 1 and the PUPSIT requirement

Annex 1 of GMP is a set of regulations guiding the manufacturing of sterile medicinal products, setting stringent regulations for biopharmaceutical processes. Within this set of regulations, PUPSIT stands out as a fundamental procedure to ensure t...

Khalil Essani
Khalil Essani
Overview of filter integrity testing methods

Overview of filter integrity testing methods

Filter integrity tests are essential in ensuring the reliability of biopharmaceutical processes – a stringent field governed by regulatory requirements such as those set forth by the FDA and GMP standards. These tests are critical components in up...

Khalil Essani
Khalil Essani
PUPSIT - An Introduction to Pre-use Post Sterilization Integrity Testing

PUPSIT - An Introduction to Pre-use Post Sterilization Integrity Testing

PUPSIT stands for pre-use post sterilization integrity testing. This method is performed once a sterilizing filter has been installed, and serves the purpose of filter integrity testing.  PUPSIT ensures that the installed filter is functional duri...

David Seifert
David Seifert

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