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Maximum safety and minimal contamination risks – barrier technologies play a crucial role in the production of aseptic dosage forms to meet the increasing requirements of the new Annex 1. The expanded use of isolators, the reduction of glove interventions, and innovative simulation methods optimize production processes and enhance product safety. Our solutions offer a well-designed combination of advanced robotics, AI-driven error detection, and precise process simulation to ensure the highest sterility standards.
The new Annex 1 requires the increased use of isolators in critical areas to minimize manual intervention and thus increase process reliability. These must guarantee Class A conditions in the cleanroom and ensure a unidirectional air flow in order to meet the requirements.
Suitable isolator solutions are part of Optima's turnkey expertise – because isolators in themselves are complex process systems that must form a unit with the filling and capping machine.
Minimizing glove interventions in isolators is a key objective of Annex 1—both for planned interventions, such as aseptic setup, and for unplanned interventions related to troubleshooting.
According to Annex 1, glove interventions are only permissible if they are justified based on a risk assessment within a Contamination Control Strategy (CCS).
Each installed glove represents a certain inherent risk, but the actual risk of glove interventions depends on multiple factors:
For example, a glove intervention in the dosing area, near open containers, presents a significantly higher risk than an intervention after capping, where containers are already sealed.
We are continuously advancing innovative, customer-specific solutions to minimize glove interventions. Our portfolio ranges from AI-based error detection to groundbreaking mechanical solutions.
Annex 1 requires regular integrity testing of glove ports using leak tests—conducted minimally at the beginning and end of each batch.
Optima provides specialized glove testing systems to verify glove integrity. Measurement data is transmitted wirelessly to the batch protocol for documentation. The correct assignment of the test disc, glove port, and glove is ensured via RFID technology, guaranteeing clear traceability of test results and glove interventions.
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According to Annex 1, airflow in critical production areas must be visually represented and documented in detail.
Optima uses state-of-the-art simulation methods to model these airflows. These simulations enable the early identification of potential improvements, ensure the First Air principle is maintained, and can seamlessly integrate into our customers' Contamination Control Strategy (CCS).
According to Annex 1, all required materials and components must be sterilized or treated through a validated decontamination process before being transferred into Class A. The introduction and removal of materials should be spatially separated or, if this is not possible, temporally separated to avoid cross-contamination.
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.
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.
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.
