Your partner for Annex 1 compliance

There are few topics currently posing as much of a challenge to the pharmaceutical industry as Annex 1. How can regulatory compliance be achieved with reliably functioning existing equipment? And what exactly needs to be changed? Syntegon is your reliable partner when it comes to these questions – with extensive expertise and an equally extensive solution portfolio.

More than two years have passed since the revised EU GMP Annex 1 came into effect, and the document is still the subject of much discussion. Pharmaceutical manufacturers and CDMOs worldwide are facing the challenge of adapting their equipment and processes to the increased requirements. The goal is to achieve the highest possible product quality, among other things by means of a suitable Contamination Control Strategy (CCS), thus preventing contamination by separating the aseptic process area from the operator environment.

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Working together for Annex 1-compliant solutions

Even before its publication, we worked intensively on the requirements of the new Annex 1 guideline. It quickly became clear that the best and most effective solutions could only be developed in close collaboration. The combination of technological expertise and specific pharmaceutical requirements is the key to true innovation – an approach that applies to all Syntegon solutions.

Of course, all our new developments are “Annex 1-ready” right from the start. At the same time, our experts support you in retrofitting existing equipment in accordance with regulations. This is where our collaborative consulting approach comes into play: Together with you and your team, our experts conduct an analysis and develop an action plan, which we then implement with concrete solutions in the next step.

Successful RABS upgrades

One example of how we supported customers in preparing for Annex 1 is RABS upgrades. You can choose between an open or closed system in a passive or active design with associated air handling. The design of the RABS components, such as material locks, glove or transfer ports, is also based on your individual specifications. Before retrofitting, we usually create a mock-up to ensure user-friendly and ergonomic machine operation. To date, we have already carried out more than 30 successful RABS upgrades together with customers from all over the world.

Focus on PUPSIT

Another topic that has gained importance in the wake of Annex 1 is the Pre-Use Post Sterilization Integrity Test, better known as PUPSIT. It makes it possible to check precisely whether sterilized membrane filters are intact and fully functional. Our PUPSIT filter testing solutions offer maximum flexibility: They are available as permanently installed or mobile trolley versions for both single-use components and reusable filters, as well as for single or double filtration configurations, and are suitable for use in isolators, laminar flow environments, and CIP/SIP cabinets. The testing process is fully automated with no direct product contact.

SPC: automation reduces manual interventions

The Annex 1 guideline not only focusses on automation regarding PUPSIT. In environmental monitoring, for example, it requires that settle plates be replaced after no more than four hours – a process that has previously been performed manually and therefore carries a potential risk of contamination. Our Settle Plate Changer (SPC) automates this process. Manual intervention in the process zone can be reduced by up to 80 percent. Calculations have also shown that machine availability can be increased by up to 300 hours per year. Just like our PUPSIT solutions, the SPC is suitable for retrofitting Syntegon equipment as well as third-party machines.

Let’s talk about Annex 1!

This selection of examples shows how intensively we have dealt with Annex 1 – and continue to do so. No matter where you are on your journey towards Annex 1 compliance, Syntegon is your partner throughout the entire machine lifecycle. Get in touch with us; we look forward to working with you on joint projects.