Ready for use butyl rubber stopper for injection or infusion by Gamma Irradiation
Gamma irradiation is a widely used method for sterilizing medical products, including butyl rubber stoppers used for injection or infusion. This process involves exposing the stoppers to gamma rays, which effectively kill any microorganisms present, ensuring the sterility of the product.
Here’s a step-by-step overview of the process:
1. Preparation of Butyl Rubber Stoppers
- Manufacturing: The butyl rubber stoppers are manufactured to the required specifications, ensuring they meet the necessary physical and chemical standards.
- Cleaning: The stoppers are thoroughly cleaned to remove any particulate matter or surface contaminants.
2. Packaging
- Primary Packaging: The cleaned stoppers are placed into primary packaging, often sterile bags or blister packs, which are then sealed.
- Secondary Packaging: These primary packages are then placed into secondary packaging, such as cartons, to protect them during the sterilization process and subsequent handling.
3. Gamma Irradiation
- Transport to Facility: The packaged stoppers are transported to a gamma irradiation facility.
- Irradiation Process: At the facility, the packages are exposed to a source of gamma radiation, typically Cobalt-60. The exposure time and radiation dose are carefully controlled to ensure effective sterilization while maintaining the integrity of the butyl rubber.
- Dosage: Common sterilization doses range from 25 kGy to 50 kGy, depending on the bioburden level and the specific requirements of the product.
- Uniform Exposure: The packages are arranged in a manner that ensures uniform exposure to the gamma rays, achieving consistent sterilization throughout the batch.
4. Post-Irradiation Handling
- Quality Control: After irradiation, the stoppers undergo quality control tests to verify the sterilization efficacy and to ensure that there has been no adverse effect on the material properties of the butyl rubber.
- Documentation: Detailed records of the sterilization process, including dosage and exposure times, are maintained for regulatory compliance and traceability.
5. Distribution
- Storage: The sterilized stoppers are stored in a controlled environment until they are ready for distribution.
- Shipping: They are then shipped to medical facilities or pharmaceutical companies, where they are used in the packaging of injectable or infusion products.
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Benefits of Gamma Irradiation for Butyl Rubber Stoppers
- Effective Sterilization: Gamma irradiation is highly effective at sterilizing a wide range of microorganisms, including bacteria, viruses, and fungi.
- Material Compatibility: Butyl rubber is generally resistant to the changes caused by gamma irradiation, maintaining its physical and chemical properties post-sterilization.
- Penetration Power: Gamma rays can penetrate deeply into packaging materials, ensuring that even stoppers in bulk packaging are effectively sterilized.
- No Residuals: The process does not leave any toxic residues, making it safe for medical applications.
Considerations
- Radiation Dose: It is critical to control the radiation dose to avoid any potential degradation of the butyl rubber.
- Validation: The sterilization process must be validated according to regulatory standards to ensure it meets the necessary sterility assurance level (SAL).
By following these steps, butyl rubber stoppers can be effectively sterilized using gamma irradiation, making them safe and ready for use in medical applications.
#Pharmaceutical rubber stopper manufacturer#
Ada Song (Mrs.) Email: hope@jytejie.com
Regional sales manager
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Jiangyin Tejie Rubber & Plastic Co.,Ltd
M:+86-18210278669
Add: No.89 Jinshi Road, Chengjiang Street, Jiangyin City, 214429 Jiangsu, China.