Purillex PFA 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® PFA bottles are the first fluoropolymer bottles designed specifically for the bioprocess industry, manufactured using proprietary stretch blow molding technology, which produces a much superior seal, without the need for a cap liner. 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. An extensive validation binder is available under NDA.
Purillex® PFA bottles are available unsterilized, but also now can be supplied autoclaved and individually pre-packaged ready-to-use (RTU). We can also provide porting, tube sets, aseptic connectors and other single-use technologies with the bottles as part of our new Integration Services offering. Please contact Savillex for more information.
Features
Specifications
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Compared with the traditional extrusion blow molding process used to manufacture all other fluoropolymer bottles, stretch blow molding produces a better seal, even at extreme low temperatures and allows the bottles to be produced inside a Class 7 cleanroom. A full 2.5 thread turns gives Purillex bottles greater thread engagement than any other fluoropolymer bottle and allows the large GL45 closure to be tightened more securely, eliminating the need for a cap liner and ensuring long term seal integrity. The smooth, injection molded inner neck shape and the absence of burrs, flash or other molding imperfections on the lip of the bottle allow controllable, drip-free pouring and complete removal of contents.
The new ETFE bottles are gamma stable, providing less risk to your process and lowering your chance of product loss. Additional benefits include:
- Better assurance of product sterility than other sterilization methods
- Longer product shelf life
- Compatible with wider variety of industry standard accessories
- No residual moisture in the container or packaging
- No absorption and outgassing of sterilant
