Sterile Vial Stoppers

STERILE VIAL STOPPERS
Bromobutyl sterile vial stoppers, sterilized by gamma-radiation.
Independent 3rd party CFU and Endotoxin testing for each lot sold.

Material and sterilization. These stoppers are molded from bromobutyl rubber, the standard elastomer for pharmaceutical closures due to its low permeability and compatibility with parenteral formulations. Each lot is gamma-irradiated for sterility and ships ready to use — no additional autoclaving or sterilization step required before use in your fill line or compounding workflow.

Sizing and configurations. Stoppers are available in 13mm and 20mm formats to match standard vial neck finishes, including round-bottom and lyophilization-style designs for freeze-dried product applications. Triple-bagged, sterile packaging options are available for facilities requiring an additional barrier layer during transfer into controlled environments such as ISO Class 5 compounding areas.

Testing and documentation. Every lot includes independent third-party CFU (colony-forming unit) and endotoxin testing, giving your quality team lot-specific documentation on hand for USP compliance review and facility audits — not something you have to request separately after the order ships.

Compatibility. These stoppers are sized to pair with standard open sterile vials in 13mm and 20mm neck formats — including the open sterile vials IVPACKS sources separately — so compounding and outsourcing facilities sourcing both components can match stopper and vial specifications from a single supplier.

Who uses these. 503A compounding pharmacies and 503B outsourcing facilities use these stoppers for sterile and lyophilized preparations requiring a closure validated for gamma sterility and documented endotoxin limits at the lot level.