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Lyophilization stoppers are specialized rubber closures used in the pharmaceutical industry to seal vials containing lyophilized products. These stoppers are designed to maintain a sterile environment and prevent contamination during the freeze-drying process. Made from high-quality elastomers, they provide an airtight seal and are compatible with various solvents and pharmaceutical formulations.
| Material | Bromobutyl rubber or silicone rubber |
| Standard sizes | 13mm to 20mm diameter |
| Temperature resistance | Up to 121°C for sterilization |
| Sterilization method | Gamma irradiation or ethylene oxide |
| Compatibility | Compatible with a range of solvents and APIs |
When selecting lyophilization stoppers, buyers should consider the material compatibility with their specific formulations and the required sterilization method. It is important to specify the size and diameter of the stopper to ensure a proper fit with the vials. Additionally, buyers should inquire about any necessary certifications, such as compliance with pharmacopoeial standards, and the volume needed for production runs to ensure adequate supply.
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They are typically made from bromobutyl rubber or silicone rubber.
They are available in standard sizes ranging from 13mm to 20mm in diameter.
Common sterilization methods include gamma irradiation and ethylene oxide.
They are generally compatible with a range of solvents and APIs, but compatibility should be confirmed.
They can typically withstand temperatures up to 121°C for sterilization.
Yes, they should comply with relevant pharmacopoeial standards and regulations.