Information about Stability Vials
Our fluoropolymer stability vials made by Savillex are excellently suitable for process validation and the performance of necessary tests within the product development cycle. Especially in the early stages of the product development, the usage of vials with small volumes is of advantage, because it only requires a small amount of the valuable drug substance to take a representative sample and analyze it. This reduces the costs for necessary studies like e.g. stability testing.
The Savillex vials are completely made of a single material and do not require an additional seal or gasket. This allows to archive a really high product quality and – unlike many other manufacturers – to avoid a mix of different materials. Because often vial, closure and seal are manufactured from different materials and this involves another risk for your process. By using Savillex vials, you can completely avoid this and protect your product.
The stability vials are manufactured from the exact same fluoropolymer as the Purillex® bottles. This feature allows to greatly simplify the validation of the production process, when switching from small volume vials to bigger volume bottles. This will save a lot of valuable time and money! The vials can also perfectly be used for production processes, as they allow to take batch related retention samples and store them safely.
Due to their high temperature resistance, these vials are also suitable for applications and processes in which final products and high potency drug substances are being flash frozen with liquid nitrogen. The Savillex vials can endure this process without any problems and assure that the quality of the sample is not affected by external circumstances.
The used material has been tested extensively and complies to the requirements of the USP Class VI as well many other regulations. The highly pure fluoropolymer has outstanding leachables and extractables values and protects the final product from contaminates.
Savillex fluoropolymer stability vials 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 storage and ship required materials to your facility within 48 hours. This allows you to save precious storage space, budget and administrative expenses!
Savillex vials are available with a volume of 3 – 15 ml. All ETFE stability vials are pre-sterilized by gamma irradiation and have a certified sterility assurance level of 10-6. PFA stability vials are available as pre-sterilized ready-to-use items, as well as non-sterilized. Further information and the part numbers of the stability vials and closures can be found in the product tabs.
The complete fluoropolymer stability vials data sheet can be found here!
Information regarding the mentioned Purillex® bottles made of PFA, ETFE or FEP can be found in the product category “Bottles & Containers”.
Features and Properties
- High Temperature Resistance
- High Chemical Resistance
- Extremely High Material Purity
- Low Extractables & Leachables
- Suitable for Freezing Applications
- Full Drainability
- „Drop Proof“
- No Material Mix
- Leakproof Testing
- Validation Binder available
Processes and Applications
- Process Validation
- Stability Testing
- Sampling Processes
- Retention Samples
- Freezing Applications
- Bulk Drug Substances
- Drug Development
Conformities and Properties
- FDA 21 CFR 177.1550
- BSE/TSE Free
- 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
- Sterility Assurance Level 10-6
- Gamma Sterilizable
- ISO Class 7 Cleanroom Manufacturing
- cGMP Standards