Sterile Bottle Filling and CGMP Compliance
21 CFR 113 of the Electronic Code of Federal Regulations (eCFR) defines aseptic processing and packaging as “the filling of a commercially sterilized cooled product into presterilized containers, followed by aseptic hermetical sealing, with a presterilized closure, in an atmosphere free of microorganisms”. Environmental monitoring and control is essential to aseptic fill/finish processes producing food and pharmaceuticals.