PUPSIT system | RoSS.PPST

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

This automated solution for filtration delivers consistent and controlled results, ensuring safety and quality in your sterile filtration process.

Request a quote Datasheet Download

ross-pupsit-pre-use-post-sterilization-integrity-testing-single-use-support

100% customizable

Fully automated

GMP Annex 1 compliant

Our customers trust in us:

Rentschler Biopharma SE

Lonza

SCHOTT Pharma

filter-iris-single-use-assembly-single-use-support

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.

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.

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.

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.

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

RoSS.FILL Bag_Product Photo_Single Use Support-7

Your customized single-use filter assembly

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

Filter Single-Use Assemblies

More information

Datasheet

Datasheet RoSS.PPST

Filesize: 0.53 MB – Mime-Type: application/pdf

More solutions

Product Photo_RoSS.PADL_Single Use Support_transparent

RoSS.PADL | Homogenizing Solution

RoSS.PADL is a scalable massaging platform for achieving a uniform mixture in single-use bags. With integrated cooling and heating, it maintains optimal temperatures consistently.

Bag Independent

Consistent Homogeneity

Temperature Control

More information

Freeze-thaw technology for handlings mAbs on another quality level

Freeze & Thaw platform

The Single Use Support freeze-thaw platforms provide insular solutions for the freeze/thaw processes of each clinical phase. Our new freeze-thaw units are fully scalable and compatible with all batch sizes and bags from all established manufacturers – you will only require one single system from the lab to blockbuster production.

More information

RoSS.FILL - single use filling system for drug substances

RoSS.FILL | Fill-Filtration

RoSS.FILL is a fully automated single-use bag filling system. This allows maximum flexibility and scalability of both the filling and draining process. It is possible to fill unlimited volumes per batch with a speed of up to 300 liters per hour. The entire filling process is fully disposable, thus warranting an absolutely sterile fill & drain process. For further productivity improvements check out our pinch valve innovation.

More information

Tell us your needs. We are here to support.

More information

Fill & Filtration

Annex 1 and the PUPSIT requirement

Annex 1 and PUPSIT meant significant changes in the pharmaceutical sector. In this article, we will illustrate the focus areas of Annex 1 and will discuss main aspects of PUPSIT.

Khalil Essani

March 13, 2024

Biopharma

Annex 1: All you need to know

Annex 1 is a fundamental framework for the production of sterile medicinal goods. This article will provide an overview of the concept, its history, contents, challenges, and perspectives.

Michael Mühlegger

March 20, 2024

PUPSIT - pre-use post sterilization integrity testing

Fill & Filtration

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

PUPSIT will contribute to simplifying not only integrity testing and validation but manufacturing processes in general, while keeping in line with current good manufacturing processes and any standards and guidelines defined by major authorities such as FDA and EMA. Read all about it!

David Seifert

March 7, 2022