BBF Sterilisationsservice GmbH

Certified according to ISO 9001,ISO 13485 and ISO 11137, BBF Sterilisationsservice GmbH offers in-house sterile packaging services, gamma sterilisation and validation according to ISO 11137. Other capabilities include pharmaceutical manufacturing according to German Drug Law (§ 13 AMG), Japanese accreditation as Foreign Manufacturer for Medical Devices and Pharmaceuticals, regular audits by FDA, microbiological laboratory services, packaging validation according to ISO 11607-1, cleaning validation and environmental monitoring.