Unique, High Purity, Gamma-Stable Solution for Low Temperature BDS Storage

Gamma Stable Game-Changer

Last time, we talked about how the bioprocessing industry could be better served by single-use fluoropolymers for storing and shipping bulk drug substance (BDS).

Our thesis came with a caveat, though: fluoropolymer materials like PFA (perfluoroalkoxy alkane), PTFE (polytetrafluoroethylene) and FEP (fluorinated ethylene propylene) aren’t gamma stable – and gamma irradiation is an industry-preferred method of sterilization.

But now, things have changed: Savillex just introduced a new range of gamma stable ETFE Purillex^® bottles.

Breaking Down ETFE Bottle Benefits

ETFE (ethylene tetrafluoroethylene) is a fluoropolymer with the same inertness, durability, material purity and low temperature working range (down to -196°C) as PFA, but with a big added benefit: gamma stability.

What makes gamma stability so important? For one thing, gamma sterilization provides a better assurance of product sterility than other sterilization methods, such as electron beam and autoclave. Because ETFE bottles can be gamma sterilized, there’s less risk to your overall process and a reduced chance of product loss.

Purillex^® ETFE bottles from Savillex are manufactured by a unique stretch blow molding process that features lower particulates, a smoother surface finish, complete content removal and superior sealing – even down to liquid nitrogen temperatures.

Other ETFE bottle benefits include:

• Available in a range of sizes up to 2 L
• No secondary seal required – only a single polymer type and grade in contact with bottle contents
• Compatibility with a wider variety of industry-standard accessories and single-use parts
• A range of stability vials is available in the exact same resin as Purillex ETFE bottles for stability studies and sample archiving

Ready-to-Use ETFE Bottles

For BDS storage and shipping applications, our ETFE bottles are available in ready-to-use (RTU) formats. That cuts out a big step in the setup process for many companies and saves significant time and money as opposed to inspecting, cleaning, sterilizing and validating bottles in-house.

Bottles are supplied double bagged and gamma-sterilized, or can be provided as assemblies with porting, tube sets, aseptic connectors and single use components as part of our new Integration Services offering.

Want to learn more? Dive into the full technical details and specs of our EFTE Purillex^® bottles.