Purillex ETFE Bottles

Purillex^®ETFE Bottles

Fluoropolymer bottles are used as single-use systems for the freezing and storage of bulk drug substance (BDS), where the properties of the BDS require it to be stored under blast freeze conditions, i.e. down to -196°C. Purillex^® bottles are designed specifically for the bioprocess industry, manufactured using proprietary stretch blow molding technology, which produces a much superior seal. Purillex bottles are also manufactured in an ISO Class 7 clean room, for greatest freedom from particulate contamination, and backed up by internal and external testing and certification. Purillex bottles come with full manufacturing lot certification.

ETFE is a fluoropolymer with the same cleanliness and low temperature working range as PFA, but has the key benefit of being gamma stable. Gamma irradiation is the preferred method of sterilization within the SUT industry. Savillex has adapted its stretch blow molding process to ETFE, producing the new Purillex ETFE bottle range. Bottles are supplied double-bagged and gamma sterilized RTU, or can be provided with porting, tube sets, aseptic connectors and other single-use technologies with the bottles as part of our new Integration Services offering.

An extensive validation binder is available under NDA. Please contact Savillex for more information.