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With innovative technologies and design solutions, such as ensuring “First Air”, Annex 1-compliant setup, or aseptic transfer, we not only meet the requirements of Annex 1 but also ensure the highest level of product safety. Learn more about how our systems minimize manual interventions and reduce risks.
Ensuring first air
Annex 1-compliant set-up: handling and installation tools
Software solutions to minimize risk
We will be happy to send you the white paper on Annex 1. You will receive an e-mail with a download link.
First Air refers to the direct, uninterrupted airflow from HEPA filters that reaches products, packaging materials, or sensitive surfaces free from potential contamination sources. With its increasing significance in the new Annex 1, the focus is on ensuring undisturbed First Air conditions including protecting critical areas, minimizing disturbances to laminar flow, continuous monitoring, and using barrier technologies such as isolators to reduce manual interventions.
According to Annex 1, product-contact components should be introduced into the system in a pre-sterilized state whenever technically possible – ideally via RTP ports or material transfer locks with isolator doors closed. During setup, direct contact with critical components using gloves should also be avoided.
Handling and installation tools, such as (removable) handles on equipment, provide an effective solution for ensuring an Annex 1-compliant setup.
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We support you in implementing continuous monitoring and documentation processes, ensuring data integrity in monitoring systems, as well as validation-compliant documentation and qualification. With solutions for real-time particle monitoring systems (e.g., BioTrak), we ensure efficient and compliant processes.
Isolator technologies, RABS systems, and digital monitoring solutions enhance safety and efficiency in the production process. Our fully integrated solutions, including turnkey isolators and CSPE approaches, cover everything from flow optimization to fully integrated Factory Acceptance Testing (FAT) for maximum safety. Additionally, the intelligent use of robotics – leveraging software and automation, including AI – reduces glove interventions.
The validation and qualification of cleaning and disinfection processes are essential for safe production workflows. We offer solutions such as PUPSIT (Pre-Use Post-Sterilization Integrity Test), effective sterilization methods for freeze dryers, and automated loading and unloading systems to optimize efficiency and compliance.
