Bromobutyl rubber stoppers are commonly used in the pharmaceutical industry, especially for sealing vials during lyophilization (freeze-drying) processes. These stoppers are designed to provide a secure seal, protect the product from contaminants, and maintain the integrity of the drug product during and after the lyophilization process.
- Material Composition: Bromobutyl rubber is a halogenated butyl rubber with bromine, which enhances its physical and chemical properties.It offers excellent gas impermeability, low moisture vapor transmission, and chemical resistance.
- Compatibility with Lyophilization: Bromobutyl stoppers can withstand the extreme temperatures (-40°C to -80°C) associated with freeze-drying without losing their sealing properties.They are designed to allow vapor exchange during the lyophilization process, which is crucial for effective drying.
- Sterility and Chemical Resistance: Bromobutyl stoppers resist leachables and extractables, minimizing interaction with pharmaceutical formulations. They are gamma-sterilizable or autoclavable.
- Applications: Commonly used for biologics, vaccines, and injectable drugs where lyophilization is needed to ensure stability and shelf life.
- Regulatory Compliance: Pharmaceutical-grade bromobutyl stoppers meet regulatory requirements such as USP <381>, EP 3.2.9, and ISO standards.
- Design and Coatings: Available in various designs (serum, lyophilization-specific) to fit different vial types and sizes.Some stoppers feature coatings (e.g., fluoropolymer) to reduce drug interaction and improve compatibility with sensitive formulations.
- Seal Integrity: Maintains a robust seal under vacuum conditions.
- Chemical Inertness: Reduces risk of contamination or interaction with drug substances.
- Flexibility: Suitable for a wide range of applications due to customizable designs.
If you need further technical details for butyl rubber stopper for lyophilization, please feel free to contact us:-
Jiangyin Tejie Rubber & Plastic Co.,Ltd
No.89 Jinshi Road, Chengjiang Street, Jiangyin City, 214429 Jiangsu, China.
