Helping Pharma Manufacturers Meet New Annex 1 Requirements

These CCS must cover the complete manufacturing process, including suppliers, and must address sterility assurance and particulate contamination.

Aptar Pharma, a leading manufacturer of primary packaging solutions, offers innovative solutions to help pharmaceutical manufacturers meet these new requirements. One such solution is PremiumFill®, an improved manufacturing process for elastomeric closure components that reduces the risk of contamination during production. This process meets the key contamination criteria outlined in the Annex 1 revision, allowing manufacturers to upgrade their operations without requiring regulatory reapproval.

In response to the Annex 1 revision’s requirement for sterile drug manufacturers to demonstrate and check the sterility of their primary packaging, Aptar Pharma offers Ready-To-Use gamma sterilized vial stoppers and syringe plungers. This validated and market-proven sterilization method provides all necessary guarantees and certificates.

To further minimize the risk of introducing extrinsic contaminants during the transfer of components on aseptic filling lines, Aptar Pharma offers components packaged in a variety of Rapid Transfer Port bags. These can be directly connected to the manufacturers’ filling lines, thereby limiting the risk of accidental contamination.

In conclusion, while the Annex 1 revision imposes stricter guidelines on manufacturers, commercially available solutions can help them implement their contamination control strategies and improve operational efficiency. These solutions, such as those offered by Aptar Pharma, are crucial in ensuring patient safety and accelerating market access.