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Reliable processes and innovative automation solutions – the requirements of Annex 1 are setting new standards for aseptic production. With our solutions for PUPSIT testing, CIP/SIP systems, validated freeze-drying processes, and robotic systems, we ensure compliant and efficient operations. Through intelligent filter and leak monitoring, real-time monitoring, and fully automated loading and unloading systems, we minimize risks.
Annex 1 defines clear requirements for PUPSIT integrity testing:
CIP (Clean-in-Place) and SIP (Sterilize-in-Place) solutions for the automated cleaning and sterilization of product-contact surfaces complement our portfolio and enhance production safety by minimizing aseptic connections.
Annex 1 emphasizes the need for scientifically sound validation of sterilization processes. Sterilization cycles, for example, require precise monitoring of temperature, pressure, and time, as well as effective air removal to ensure complete sterilization. Routine operating parameters must be strictly maintained and thoroughly documented.
Freeze dryer sterilization at OPTIMA
According to Annex 1, systems such as hydraulic units, heating, and cooling systems should, where possible, be located outside the processing area. Any leaks that may pose a risk to the product must be detectable via an appropriate indication system.
At Optima, mass spectrometry is used as a versatile solution that combines precise detection of silicone oil leaks with effective monitoring of humidity and system integrity:
We will be happy to send you the white paper on Annex 1. You will receive an e-mail with a download link.
Our continuous real-time monitoring enables seamless integration into the freeze dryer software and provides constant insight into the process – resulting in improved reproducibility, quality assurance, and precise control of the freeze-drying cycle.
According to Annex 1, robotics and automation should also be used in freeze-drying processes to avoid critical human intervention – for example, through automated loading and unloading of freeze dryers. The transfer of partially closed containers must always occur under Grade A cleanroom conditions and with minimal operator involvement.
We offer innovative solutions for fully automated loading and unloading of freeze dryers:
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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.
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.
A wide range of innovative technologies help you master key production challenges. Whether it’s new acquisitions, modernization, process optimization to prevent contamination, or risk management – we offer carefully planned, field-tested solutions.
