ETFE Bottles

Description

Information about ETFE Bottles

GMPTEC is the German-speaking partner of Savillex and offers a range of high-purity fluoropolymer bottles and vials under the brand name Purillex®. These bottles excel due to their very high temperature and chemical resistance, which cannot be archived by alternative products.

Depending on the application and specific requirements, there are three different materials available:

• PFA – autoclavable
• FEP – autoclavable
• ETFE – gamma sterilizable

Purillex® ETFE bottles distinguish from PFA and FEP bottles due to the fact, that they can be pre-sterilized by using gamma irradiation and are supplied as “ready-to-use”. This saves the trouble of autoclaving the bottles and assures the highest level of safety, because the sterilization process has been validated to a sterility assurance level of 10^-6.

Many of the commonly used components in biopharmaceutical processes are made to be sterilized by gamma irradiation. Since the ETFE Purillex bottles can also be gamma irradiated, it’s possible to combine them with many other components and even build complete systems. This enables very flexible usage and easy integration into existing processes.

Purillex® ETFE bottles are especially suitable for critical applications and processes, in which valuable drug substances and final products are being filled and afterwards frozen by using liquid nitrogen. Due to their enormous temperature resistance of up to -200 °C to +50 °C, these bottles can be frozen without any problems. They don’t have any negative impact on the product quality and help to prevent costly loss of produced batches. The bottles and vials can also be used to keep and storage retention samples. This assures that the sample is not affected by uncertain factors, which could lead to the corruption of test results.

All Purillex® bottles made by Savillex are produced in a special stretch blow molding process. This innovative production process allows to reach a very high product quality and manufacturing accuracy. All bottles have a non-sticking surface and a smooth transition to the bottleneck, which allows to completely empty the bottle. This also means that the bottles can be cleaned very effectively. This is a very important factor, especially when the fluoropolymer bottles are being used multiple times, because it minimizes the risk of contamination from residues.

Both, the bottle and closure, are made from the exact same ETFE material. This assures that there is no material mix when using Purillex® bottles, like it’s the case for almost every other bottle with closure. The closure of the Purillex® bottles has more threads than a regular bottle, which increases the process safety and seals the bottle perfectly. Their special design and the precise manufacturing process eliminate the need for an additional gasket within the closure.

The used ETFE material is extensively tested, certified, complies to USP Class VI and a vast number of other regulations. The bottles have outstanding leachable and extractable values and are nearly unbreakable due to their robust design. Savillex has also performed comprehensive internal testing on all Purillex bottles, including drop test, leakproof test, vacuum resistance and pressure burst test. Validation data and test reports are available upon request.

Purillex™ fluoropolymer bottles feature a shelf life of 5 years from date of manufacture, which allows to perfectly stock larger quantities. We will gladly take care of keeping your personal stock of bottles in our warehouse and ship required materials to your facility within 48 hours. This saves precious storage space, budget and administrative expenses!

Of course, our high purity fluoropolymer bottles can also be delivered as customized bottle assemblies. This means that the bottles will be equipped with tubing and connectors according to your individual requirements. This allows you to easily integrate a completely closed bottle into your existing processes.

The complete Purillex® data sheet can be found here.

Features and Properties

• High Temperature Resistance
• High Chemical Resistance
• Extremely High Material Purity
• Low Leachables & Extractables
• Suitable for Freezing Applications
• Full Drainability
• „Drop Proof“
• No Material Mix
• Leakproof Testing
• Validation Binder available
• Gamma Sterilized
• Double Bagged
• Ready-to-Use

Processes and Applications

• Single-Use Assemblies
• Filling Applications
• Flash Freezing Applicatisons
• Transport and Storage
• Retention Sampling
• Bulk Drug Substances
• Drug Development

Conformities and Properties

• FDA 21 CFR 177.1550
• Animal Derived Component Free (ADCF)
• USP <88> Class VI Biological Reactivity
• USP <87> Cytotoxicity Test
• USP <85> Bacterial Endotoxins Test
• USP <788> Particulate Matter in Injections
• USP <661.2> Physiochemical Tests of Plastics
• USP <891> Thermal Analysis
• Certificate of Conformance
• Batch Tracebility
• Gamma Sterilized (SAL 10^-6)
• ISO Class 7 Cleanroom Manufacturing