Single-Use Filter Transfer Assemblies for Final Filling
Pre-Designed, Regulatory Compliant, and PUPSIT-Optimized
Sartorius' single-use filter transfer sets reduce wait times by up to 80% with an industry-first, pre-designed solution for final filling filtration. The standardized design, combined with consistent operating procedures, simplifies handling and reduces the risk of operator error across all filter types and sizes. Each qualified, sterile filter transfer set for final filling is fully compliant with PUPSIT requirements outlined in EU GMP Annex 1.
See how standardization can shorten final filling project timelines compared to traditional filter transfer assemblies.
Receive pre-designed filter assemblies that are qualified, sterile, and ready to use within 9 weeks—with up to 80% less wait time compared to engineered filter assemblies.
Pre-designed solutions are regulatory compliant and comply with PUPSIT requirements contained in the EU GMP Annex 1.
Mitigate operator error across batch sizes and drug substances with a highly standardized product design and consistent operating procedures.
Stainless steel holders simplify installation and operation, ensure optimal component placement, minimize residual volume, and prevent product loss.
The toolbox of the pre-designed solution includes various types of sterile connectors, tubes, filters and further configuration options to satisfy almost any need for single or redundant sterile filtration in final filling. Flexibility extends far beyond the toolbox for single-use assemblies. We offer a standardized holder that can be operated manually or customized into an automated skid to ensure compatibility with your specific requirements.
Explore Our Solutions
Manual PUSPIT-Ready Solution
Our manual PUPSIT-ready solution is designed to optimize the sterile filtration workflow. A small but innovative design feature of the filter assembly allows the use of automated pinch valves, enabling easy integration into a fully automatic filling process. Discover its configuration flexibility.
Automated PUPSIT System
PUPSIT requires multiple critical steps to ensure product security. Sartorius offers an automated PUPSIT system to minimize errors that could happen during manual processing, creating a complete solution to automatically process filter wetting, integrity testing, filter drying, and the filtration procedure. The automation concept also enables integration and communication with the filling line.
Engineered vs. Pre-Designed Solution
Save Time and Simplify Operations With a Pre-Designed Solution
The table below compares project timelines for a typical engineered solution versus Sartorius’ single-use filter transfer set for final filling. Our industry-first, pre-designed solution arrives qualified, sterilized, and ready to use—delivered in as little as 9 weeks*, including the assembly holder.
| Phase | Engineered Solution | Pre-Designed Solution | |
|---|---|---|---|
| Concept phase | 4 weeks | 0.5 weeks | |
| Design and quote | 4 weeks | 0.5 weeks | |
| Prototype delivery | 3-12 weeks* | ||
| Single-use design adaptations | 2 weeks | ||
| Design approval, including creation of manufacturing documents | 4 weeks | ||
| Typical lead time for single-use assembly (initial order) | 12-20 weeks* | 8 weeks* | |
| Total single-use assembly | 46 weeks* | 9 weeks* | |
| Holder for single-use assembly | Customer responsibility (typically 24 weeks ) | Within single-use assembly lead time | |
| Total | 70 weeks* | 9 weeks* | |
| View Products | Consult Our Experts | ||
*Delivery time may decrease or increase due to the global component supply situation.
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Frequently Asked Questions
PUPSIT stands for pre-use post-sterilization integrity testing It is a procedure used to verify the integrity of sterilizing filters before they are used in the final filling process. This testing ensures that the filter is intact and capable of effectively removing microorganisms, thereby maintaining the sterility of the product. PUPSIT is crucial for compliance with regulatory standards and for ensuring product security, as it helps detect any potential filter defects that could compromise sterility
Yes, PUPSIT is used to detect filter flaw masking. While suppliers test the integrity of sterile-grade filters, defects can occur during transportation or sterilization, which are beyond the manufacturer's control. PUPSIT verifies filter integrity post-sterilization, identifying hidden defects to ensure product sterility and effective contamination control.
Standardized filter assemblies allow identical operator actions across different filter sizes and batch volumes, simplifying training and reducing errors. This consistency enhances operational efficiency, ensures reliable performance, and facilitates easier process control and documentation, improving overall security and compliance.
According to Annex 1, the filter should be placed close to the filling point to minimize contamination risks. A restricted access barrier system (RABS) offers advantages over isolators such as greater flexibility, easier setup, and the ability to perform open-door interventions while maintaining a Grade A environment. RABS is an adaptable solution that allows spatial separation between the filter line and filling equipment.
As soon as two sterilizing-grade filters are used one after the other, they should be integrity tested pre-use post-sterilization if compliance with EU GMP is required. For post-use integrity testing, only either the primary filter or the secondary filter needs to pass the post-use integrity test.
