For the manufacture of PE vials a high-density polyethylene (PEHD) is used. This material is medical grade and fulfils the Ph.Eur. regulations.
The FDA has a Drug Master File for our standard PEHD material – no DMF 5654
The material has also passed the USP tests for a Class VI plastic, and physico-chemical testing of the material has met the USP limits.
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 PE 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. PE material is suitable for irradiation.