LYOSEAL™by Biocorp Our answer to Annex1 requirements
October-28-2005, ANNEX 1:EMEA draft amendment «Partially stoppered freeze drying vials should be maintained under Grade A conditions at all times, from the time of partial stoppering to capping.
The container closure system for aseptically filled vials is not fully integral until the aluminium cap has been crimped into place. Vials should be maintained in Grade A environment until the cap has been crimped. As the equipment used to crimp vial caps can generate large quantities of non-viable particulates, the equipment should be locate data separate station equipped with adequate air extraction. The capping station may not be able to meet Grade A conditions for non-viable particles in the “in operation” condition but should meet the microbiological requirements.»
