Annex 1 Compliance » Syntegon

Skip to content

1920x600_Annex1

The revised EU GMP Annex 1 sets higher standards for contamination control, risk management and barrier technologies in aseptic manufacturing. Staying compliant requires updated processes, upgraded equipment and a resilient contamination control strategy.

We provide the expertise and solutions to help you meet these requirements, whether you are investing in new equipment or modernizing your existing lines.

Book a 1:1 consultation Downloads

Please accept marketing-cookies to watch this video.

Settle Plate Changer

Environmental monitoring is essential in aseptic manufacturing and has become even more important in the context of Annex 1. This means that settle plates must be changed every four hours to ensure consistent sampling. The Syntegon Settle Plate Changer is a robotic handling unit that handles this process reliably and without manual intervention, reducing contamination risks.

Download brochure Learn more

750x420 _pupsit

Pre-Use Post Sterilization Integrity Test (PUPSIT)

PUPSIT is a vital validation step designed to confirm filter integrity after sterilization but before use. The Syntegon filter test rack solution offers maximum flexibility – available for single or double filtration setups, suitable for use inside isolators or laminar flow environments, and even as a mobile trolley configuration for versatile integration into existing production setups.

Talk to an expert

Please accept marketing-cookies to watch this video.

Barrier technologies / RABS and isolators

Syntegon offers a comprehensive portfolio including open RABS, closed RABS, containment and isolator systems. All solutions are tailored to customer requirements, from machine design and development to on-site installation and validation. Of course, we also support you in getting your existing lines “Annex 1-ready” with appropriate retrofit solutions.

Download brochure Learn more

First Air

Annex 1 emphasizes the importance of uninterrupted First Air in critical zones. To support this, Syntegon’s fill – finish equipment is engineered with UDAF – friendly parts and removable, autoclavable components.

We also offer flow simulations – complete with documentation – to verify First Air integrity, whether for new systems or existing machines.

Download brochure

Picture_QualityRiskManagement

Qualification and validation services

Qualification and validation activities demonstrate that the design and procedures have been implemented correctly and continue to perform in line with expectations.

We offer a wide range of EU GMP/PICs and US cGMP-compliant qualification and validation services – including risk analysis workshops. You can choose from our different activities according to your needs.

Learn more

syntiso

Innovation spotlight

SynTiso – The world’s first gloveless, fully automated, Annex 1 compliant commercial fill & finish line

Developed with industry partners, SynTiso meets today’s demands for high performance, maximum product yield, and minimal operator intervention.

Its gloveless isolator enables full automation and reduces human interaction. SynTiso helps minimize contamination risks and eliminates the need for manual settle plate handling.

Innovative Technologies We enable customers to lead in their markets.

Learn more

Downloads

Viable monitoring: Automated change of settle plates

Viable monitoring: Automated change of settle plates

Retrofit Settle Plate Changer

RABS retrofit

RABS retrofit

Meet the new requirements by retrofitting your existing equipment with our RABS.

Isolator Systems

Isolator Systems

Safety and performance from one source.

Air Detector System

Air Detector System

Ensure Annex 1 compliance by upgrading your vacuum-steam sterilizers with our fully automatic and integrated test system.

Our all-inclusive service solutions – covering service agreements, preventive maintenance, spare parts, and operator training – are just the beginning. With us, production lines are always running at their best.

Service Agreements

Service Agreements

Find out more about our Service Agreements here.

Digital Solutions

Digital Solutions

Find out more about our Digital Solutions here.

Expert Services

Expert Services

Find out more about our Expert Services here.