curtains预灌封注射器用溴化丁基橡胶活塞英文标准
The English standard for pre-filled syringes with bromobutyl rubber pistons can be described as follows:
1. Piston Material: The piston material ud in pre-filled syringes is bromobutyl rubber. Bromobutyl rubber is a synthetic rubber that is highly resistant to permeation by gas and moisture. It is also known for its excellent chemical resistance, stability, and low extractables.
2. Piston Design: The piston design should ensure a proper al within the syringe barrel and provide smooth movement during the injection process. The piston should have a tight fit to prevent leakage and maintain the sterility of the drug product.
3. Physical Properties: The bromobutyl rubber piston should have specific physical properties to ensure its suitability for u in pre-filled syringes. The properties incl
梅花鹿的英文ude good flexibility, high tensile strength, low compression t, and resistance to aging and degradation.
偶尔4. Chemical Compatibility: The bromobutyl rubber piston should be chemically compatible with the drug product it contains. It should not react with the drug or leach any harmful substances into the drug solution. The piston material should be tested for its compatibility with a wide range of drugs to ensure safety and efficacy.
初中补习网站timberwolves5. Sterilization: The bromobutyl rubber piston should be sterilizable using common sterilization methods such as gamma irradiation or ethylene oxide gas. It should withstand the sterilization process without degrading or compromising its performance.
米兰敕令
6. Regulatory Standards: The bromobutyl rubber piston ud in pre-filled syringes should comply with relevant international standards and regulations. The may include standards t by regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other national regulatlookinto
amalgamory authorities.
lawyer
7. Quality Control: Manufacturers of pre-filled syringes with bromobutyl rubber pistons should implement stringent quality control measures to ensure the consistency and reliability of the product. This may involve testing the pistons for dimensional accuracy, physical properties, chemical compatibility, and sterility.
totesIt is important to note that the specific English standard for pre-filled syringes with bromobutyl rubber pistons may vary depending on the regulatory requirements of different countries or regions. Manufacturers and urs of such syringes should refer to the applicable standards and regulations in their respective jurisdictions to ensure compliance and safety.
