We use a medical grade random copolymer polypropylene in natural and amber for manufacturing our range of vials. The material fulfils the Ph. Eur. regulations.
FDA has a Drug Master File for the material – no DMF 5591 and 14881, and for a selection of our vials – no DMF 14293 which is available by contacting MedicoPack.
Only virgin material is used in our production according to Ph. Eur. Current Ed. (3.2.2, last supplement) “Plastic Containers and Closures for Pharmaceutical Use”.
The vials are packed in our clean room class 10,000 (C). The clean room is constructed according to EU Directive 91/356 EEC and 91/412 EEC inclusive of guidelines. The air of the clean room is automatically controlled and the monitoring and alarm system functions 24 hours a day, enabling immediate intervention if disruptions arise.
Bacteriological control and particle control are performed at regular intervals in the clean room to ensure that the system is working. PP vials are suitable for autoclaving at 121°C.