Compliance With Annex 1- Sterile Fill Finish

Eurofins BioPharma Product Testing addresses the revised 2023 European Union Annex 1 guidelines by implementing advanced solutions for sterile fill-finish processes, particularly for early-phase drug products. A cornerstone of Annex 1 compliance is the Contamination Control Strategy (CCS), which minimizes contamination by removing operator interaction through isolator technology. Robotic isolators, like Cytiva’s Microcell™, establish ISO 5 environments, removing the need for gloves and minimizing human interference. These systems are validated using hydrogen peroxide sterilization cycles and airflow studies that ensure unidirectional, HEPA-filtered protection over product vials.

Pre-Use Post Sterilization Integrity Testing (PUPSIT) is emphasized as a key requirement, verifying filter integrity both before and after sterile filtration. Though previously underused in the U.S., Eurofins supports its integration using single-use, gamma-sterilized filter trains and validated testers. The system’s design reduces risk and complies with Annex 1 exceptions when justified.

To prevent particulate contamination, Eurofins utilizes press-cap technology instead of traditional crimping, within leak-tested Class A isolators. Critical zones are monitored continuously for particles and viable contamination, and single-use systems reduce cleaning and handling errors.

Compliance extends to cleanroom operations, personnel training, and rigorous Aseptic Process Simulation (APS), which mimics real-world processes and must be validated biannually. APS tests cover media dissolution, filtration, filling, and microbial detection through incubation.

Eurofins' integration of cutting-edge isolator systems, robust monitoring, and comprehensive training ensures full alignment with Annex 1, positioning it as a leader in sterile manufacturing for early-phase clinical products.