Making Facilities Fit for GMP Annex 1

ZETA supports Pharma & Biotech companies in achieving GMP Annex 1 compliance. With deep expertise in aseptic facility design, ZETA develops tailored solutions like PUPSIT systems—ensuring regulatory readiness and robust, sterile processes.

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Driving GMP compliance in biopharma processing

ZETA has a pivotal part to play in supporting its customers to achieve Annex 1 readiness: The best subject-matter experts have both the technical knowledge in GMP-compliant, biopharmaceutical processing and many years of experience in designing aseptic facilities. This is why ZETA is the perfect partner when it comes to the identification and closing of gaps in achieving Annex 1 regulatory compliance. ZETA engineers turn those gaps into robust solutions – as shown by an impressive best practice example.

Solution development for point-of-fill filtration and filter integrity testing (PUPSIT)

In close consultation with the customer, ZETA developed, tested and evaluated in a feasibility study several possible technical solutions for the implementation of sterile filtration systems on the filling lines. A perfect basis for the pharmaceutical manufacturer’s decision!

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Michael Christ

Teamleader Project Management

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