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.
In aseptic production plants, additional components are required in the area around the filters. These include process valves, fittings, sensor systems and connections, for example for sterile steam supply, condensate discharge and venting. It must also be possible to perform the integrity tests specified by the authorities.
Conventionally, these components are often welded directly onto the filter base or filter cover – either individually or as prefabricated subassemblies – which has an impact with regard to space requirements, weld seams and dead spaces.
A multi-port valve block combines these functions into a single compact unit, forming the basis for reliable and validatable process control.
Example of a flow chart of a multi-port block valve for your PUPSIT process
SOLUTION PRINCIPLE
Multi-port block valves bring together all the connections you need into a single compact unit.
The filter base, valves, fittings, sensor systems and connections are no longer integrated as single components, but are manufactured from a solid stainless steel block.
The result is a complete filter unit comprising a filter base, filter hood and filter cover, forming an integrated system.
Solution approaches
A variety of technical approaches and product solutions are available for implementing PUPSIT. Traditional plant designs with single components are, in their essence, completely different from integrated multi-port block valve solutions. The differences are particularly evident when it comes to process reliability and the time and money required for integration.
Traditional construction with single components and separate interfaces.
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Block solution adapted to your requirements as an integrated filter unit.
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This 3D representation clarifies the conventional approach, in which individual valves and components are added and integrated into the piping system, resulting in a corresponding space requirement and increased deadleg.
This 3D illustration demonstrates the GEMÜ approach: process-relevant connections, valves and components are customized according to the required process connections and integrated into a compact multi-port block valve.
A lower number of weld seams and minimized deadleg reduce the risk of contamination and product loss.
Several functions are integrated into a single block, allowing for a compact plant structure.
Components and sensor systems can be flexibly integrated into customized designs and ensure optimized process conditions.
Fewer interfaces reduce the effort involved in testing, documentation and qualification.
Single-Use solutions for PUPSIT applications are characterised by a clearly structured, often linear arrangement of components.
When it comes to efficiently integrating all components into the (existing) production environment, the focus is on minimizing connection points and maximizing process reliability.
Alongside this, sterility, reproducibility and documentation must be ensured at all times. Single-Use solutions allow for compact and flexible implementation in this regard.
Example of an excerpt from a flow chart of a customized flowpath
SOLUTION PRINCIPLE
Single-Use solutions allow for a precise, space-saving system design for the PUPSIT solution by integrating the components into the tubing assembly.
Forgoing CIP/SIP integrations and condensate discharges leads to a reduction in complexity and lays the foundation for a streamlined, process-oriented system layout.
Solution approaches
A variety of Single-Use components is available for implementing PUPSIT-compliant processes – from pinch valves through to complex, multi-functional valve manifolds. Selecting the appropriate solution depends on the specific process setup as well as the regulatory and spatial requirements of the plant.
Pinch valves are a reliable industry-standard option for your PUPSIT application.
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SUMONDO diaphragm valves and multi-port solutions offer enhanced functionality.
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Our multi-functional solutions are the ideal choice for customizing your PUPSIT process.
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Reliable and safe open/close function with reduced risk of contamination.
Minimised dead spaces and compact tubing routing in your flowpath.
Versatile integration of individual components into your plant design.
Production and documentation designed for use in GMP environments.
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.
