Knowledge Article
PUPSIT - from requirements to reality: Automation that simplifies and secures production
When EU GMP Annex 1 made PUPSIT mandatory for sterile filtration, many biopharma manufacturers faced new and more stringent requirements. The rule change increased safety and quality but at the same time increased complexity - with more steps, valves and extensive documentation requirements.
Many businesses needed to find ways to comply with regulations without reducing productivity or disrupting existing process flows. The challenge was to combine strict compliance with an efficient, stable and user-friendly process.
Together with Parker Hannifin, we at Colly Flowtech offer the automated PUPSIT solution Parker SciLog® NFF+PF, which provides safer processes, better control and higher efficiency at every step. The result is a stable production with consistent quality in every batch.
Why PUPSIT is a challenge
PUPSIT (Pre-Use Post-Sterilization Integrity Test) were introduced to improve quality and ensure filter integrity before product contact. Nevertheless, many businesses find it challenging to adapt their processes to the new requirements, mostly due to three recurring challenges:
1. Sterile barrier and risk of leak points
Extra valves, sampling points and waste must be built in without creating new entry points for contamination.
2. Humidification and air/liquid control
The filters need to get completely wet to avoid false failures, which can be challenging both with final product and WFI.
3. Reproducibility and data traceability
Manual steps make it difficult to ensure identical sequences, correct set-points and a complete audit trail for each batch.
Success requires a solution that combines process control, repeatability and smooth data collection, without adding complexity to production.
Parker SciLog® NFF+PF: Our Automated PUPSIT solution for safer and more efficient production
To meet these challenges, Colly Flowtech, together with Parker Hannifin, offers the PUPSIT automated solution Parker SciLog® NFF+PF. The solution is designed to remove common sources of error and make PUPSIT simpler, safer and more consistent.
With designed flow paths, controlled sequences and support for both bubble point and diffusion flow, you get higher reliability, more consistent results and smoother compliance.
Parker SciLog® NFF+PF offers:
- Recipe management for wetting, filtering and testing
- Pressure and flow control with electronic batch log and audit trail
- OPC integration to higher-level systems
- Siemens S7-1500 / TIA Portal and user-friendly HMI
- Support for 21 CFR Part 11 / Annex 11
- Possibility of redundancy (NFF+ PFR) for risk reduction
- Up to two integrated scales for accurate end points and product recovery
The result is a controlled and reproducible sequence that guides the operator step by step, reduces manual steps and variation and ensures complete documentation for review and inspection.
Example of a typical work sequence
To give a clear picture of how Parker SciLog® NFF+PF controls the process, here is a typical work sequence. All steps are automatically logged and linked to the batch audit trail for full traceability:
- Manifold leak test at installation
- Wetting/priming of sterile filters
- PUPSIT (diffusion flow/bubble point)
- Product filtering including sampling
- Product recovery/blowdown & drying
- Post-use integrity test
The benefits of automated PUPSIT solution
With Parker SciLog® NFF+PF, PUPSIT is not only automated, it also becomes more consistent and efficient. The solution collects and documents every step in the process and provides a smoother everyday life in production. Below we have listed some of the benefits that Parker SciLog® NFF+PF offers:
- Standardized sequences reduces manual effort and operator variation, resulting in more consistent results over time.
- Automatic data logging with batch report and audit trail makes audit and inspection faster and less resource-intensive.
- Optimized wetting/priming and air/liquid control reduces product waste, prevents false errors and minimizes the need for retesting.
- Built-in data integrity according to Annex 1 and 21 CFR Part 11/Annex 11 simplifies compliance with regulatory requirements.
- Flexible integration and redundancy ensures stable operations and the ability to respond to changing risk scenarios.
Future-proofed and customized - for your unique process
Parker SciLog® NFF+PF meets today's regulatory requirements and is ready for tomorrow. With built-in data integrity, electronic batch log, and integration with higher-level systems, you get a solution that can grow with production and future quality requirements.
At the same time, every production environment is unique. That's why at Colly Flowtech we always start by understanding your process and conditions in depth - whether it's small-scale clinical manufacturing or large-scale commercial production.
By combining Parker Hannifin's technology with our experience of working with PUPSIT, we ensure a solution that works in practice, enhances safety and efficiency and makes a difference where it really counts - in your production.
Want to know more? Contact us at Colly Flowtech or email Patrik Andersson directly at patrik.andersson@colly.se and we'll be happy to tell you more.
This text was written by Viktor Fredriksson (viktor.fredriksson@colly.se), Product Manager Hoses at Colly Flowtech.
Frequently asked questions about PUPSIT
Why is PUPSIT important in sterile filtration?
PUPSIT ensures that the filter is fully intact after sterilization but before product filtration. It prevents contamination and meets the requirements of EU GMP Annex 1.
How does PUPSIT work?
The filter is sterilized, wetted and tested for integrity - for example with a bubble point or diffusion flow test. If the test passes, filtration can begin.
What testing methods are used in PUPSIT?
Common methods are the bubble point test, diffusion flow test and pressure hold test. They verify that the filter is tight and sterile.
What happens if PUPSIT fails?
The filter must be replaced and the process restarted. The product must not be used if sterility cannot be guaranteed.
What are common challenges with PUPSIT?
Common challenges include difficulties with process design, proper wetting and documentation according to regulatory requirements. Automation can solve many of these problems.
Do you have any questions?
Viktor Fredriksson
Product Manager - Slang
Phone:
+46 73 840 40 10
Email:
viktor.fredriksson@colly.se
Patrik Andersson
Product Specialist - Filters
Phone:
+46 76 492 03 89
Email:
patrik.andersson@colly.se
