Annex 1 compliance: implementing PUPSIT right

Jan 30, 2026 | 3 min read

Pharmaceutical manufacturers and CDMOs are currently facing a decisive question: how to implement the challenging PUPSIT procedure reliably and efficiently? Syntegon has the solutions and expertise to ensure precise PUPSIT for your production.

Contents

Key Takeaways
              With the revised EU GMP Annex 1, PUPSIT has effectively become mandatory and is increasingly evolving into a global regulatory standard.
PUPSIT enhances patient safety and prevents batch losses by detecting filter defects before product exposure.
Its implementation requires highly precise, automated, and gentle testing processes suitable for different filter materials.
Syntegon addresses these requirements with fully automated, flexible PUPSIT solutions for both new and existing filling lines.

            

Since the revised EU GMP Annex 1 came into effect in 2023, followed by the recommendation of the European Medicines Agency (EMA) to use pre-use post sterilization integrity testing – better known as PUPSIT – over risk analyses, manufacturers and CDMOs producing in or for the European market can no longer treat PUPSIT as an optional add-on. Moreover, further regulatory bodies including the FDA and the WHO are increasingly discussing PUPSIT as part of good manufacturing practices. Manufacturers that integrate PUPSIT now not only comply with today’s requirements – they are preparing their filling lines for tomorrow’s global standards.

Why PUPSIT matters

PUPSIT addresses a simple but critical question: Are sterilized product filters intact and fully functional at the point of use? Even tiny defects in product filters can jeopardize entire batches and ultimately patient safety. In case of a defect, PUPSIT can identify it before valuable product is exposed, avoiding the need to discard complete batches when issues emerge only during later inspections. This is an important factor for protecting both patients and resources, especially for companies producing high-value products.

Meeting PUPSIT challenges with precise automation

However, implementing PUPSIT comes with some challenges. Detecting defects in filters made from different materials and supplied by different vendors calls for reproducible, highly precise, and automated processes. PUPSIT itself imposes mechanical and thermal stress on sensitive filters. Hence, testing must be gentle and rigorous at the same time. Syntegon has translated these challenges into fully automated testing solutions for single-use filtration kits that require no operator intervention – answering pharmaceutical and biotech manufacturers’ needs for precision, reliability, and efficient procedures.

Syntegon Filter Test Rack – the benefits
              Enables both bubble point and forward flow PUPSIT methods
Test procedure with product or water for injection (WFI) possible
Recipe-driven, automated PUPSIT procedure
No direct contact between machine parts and product
Hygienic design for optimal cleaning
Flexible function block selection and combines sequences
Single or double filtration to fit your process needs

            

Flexibility for all containment needs

In highly regulated aseptic environments, PUPSIT must integrate seamlessly into existing workflows and different production layouts, support operators, and respect tight production timelines rather than extending them. Our Filter Test Racks allow you to choose the configuration that best meets your spatial, containment, and process requirements.

Syntegon Filter Test Rack – the configurations
              Filter Test Rack in a fixed cabinet – offers comfortable access
Filter Test Rack in a fixed cabinet with laminar flow hood – combines easy access with optimal air quality
Filter Test Rack in a mobile trolley – for flexible positioning and easy integration into existing setups
Filter Test Rack inside cRABS – provides an added level of operator protection combined with good accessibility
Filter Test Rack inside isolator – offers the highest level of protection for highly potent products

            

Partner with us for PUPSIT

To leverage the benefits of PUPSIT beyond Annex 1 compliance, testing equipment and procedures need to combine precision, reliability, and product protection with efficiency and flexibility. Syntegon offers you seamlessly integrated solutions that do just that – built into new liquid filling lines or as retrofits for existing Syntegon or third-party equipment. Contact our experts to future-proof your production for global compliance with PUPSIT!

Annex 1 compliance: implementing PUPSIT right

Key Takeaways

Why PUPSIT matters

Meeting PUPSIT challenges with precise automation

Syntegon Filter Test Rack – the benefits

Flexibility for all containment needs

Syntegon Filter Test Rack – the configurations

Partner with us for PUPSIT

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