Product solutions for PUPSIT
With the publication of the EU GMP Guidelines Annex 1 (2022 Revision), PUPSIT is becoming increasingly important in pharmaceutical production processes. Bespoke product solutions from GEMÜ, tailored to your specific application, can ensure you are in compliance with regulatory requirements.
Regulatory context
According to Annex 1 (Revision 2022), PUPSIT (Pre-Use Post-Sterilization Integrity Test) is the standard method to prove the functionality of sterile filters in the manufacture of sterile medicinal products – provided that the product cannot be sterilised in its final container.
PUPSIT ensures that sterile filters are in good working order before use, thereby preventing undetected damage from leading to microbial contamination of the product. In some instances, the integrity of the filter is also after the filtration process. Exceptions are permissible only in justified cases and must be substantiated comprehensively and on the basis of risk.
The increasing requirement for validation and documentation quickly become a hurdle, particularly with flexible production strategies. To comply with the specifications of GMP Annex 1, plants are often modified or expanded – the solution that is employed therefore needs to be technically integrated into your existing plant infrastructure.
Crucial in this regard are the reliable implementation and comprehensive documentation of integrity tests, the reliability and reproducibility of the results, and the avoidance of any additional risk of contamination.
SAFETY. RELIABILITY. CUSTOMIZABILITY.
GEMÜ’s PUPSIT solutions bring together decades of expertise with innovative technology – because for us, integrity is not a maybe, it’s a must.
As a reliable partner that is with you every step of the way, we look beyond our standard product range and work with you to find the perfect solution that you can always rely on.
Understand. Develop. Implement.
The first step towards a solution
Whether it’s a customized multi-port block valve or a complex Single-Use solution, please provide us with your sketch or P&ID to give us an insight into what you’re looking for. Together, we will use this to lay the foundations for a clearly defined project.
Digital or on-site
During a face-to-face meeting, we will discuss your application in detail, clarifying interfaces, requirements and boundary conditions. Throughout this discussion, we always keep your objective in mind: a solution that is both technically sound and cost-effective.
Working together on a solution
Based on your specifications, we will draft a bespoke solution proposal. We will work with you to fine-tune, adapt and further develop the proposal – until everything is perfect.
Ready for use on your premises
Once everything has been agreed with you, we will deliver your multi-port block valve or system solution; it will be ready-to-install, tested and fully documented – reliably and perfectly customized to your application.
