Given their critical role, pharmaceutical rubber stoppers must comply with rigorous international standards and regulations. Organizations such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and the International Organization for Standardization (ISO) set guidelines for material composition, extractables limits, and biocompatibility.
Compliance ensures that rubber stoppers are free from harmful substances, meet mechanical strength requirements, and are suitable for direct contact with medications. Many manufacturers produce stoppers that meet USP Class VI certification, indicating they have passed comprehensive biocompatibility and toxicity testing.
Adherence to these standards reassures pharmaceutical companies and regulatory bodies that the stoppers contribute to the overall safety and efficacy of the drug product.
Pharmaceutical rubber stoppers are typically supplied in sterile packaging to maintain their cleanliness until use. They are sterilized using methods compatible with the rubber material, such as gamma irradiation or ethylene oxide, ensuring they are free from microbial contamination.
Proper packaging also prevents physical damage and contamination during transport and storage. This attention to detail in sterilization and packaging further enhances the stopper's performance in safeguarding medications.
Pharmaceutical rubber stoppers are used in a wide range of applications, including vaccines, injectable drugs, diagnostic reagents, and nutritional supplements. Their ability to create secure seals for both glass and plastic containers makes them versatile components in pharmaceutical packaging lines.
Some stoppers are designed for specific functions, such as self-sealing for repeated needle punctures or with integrated coatings to reduce friction. These specialized stoppers improve usability and patient safety in clinical settings.
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Stable production, Mature technology, Quality stability. It has been normally supplied to Baxter Suzhou Plant for 10 years.
Pure formula and Good compatibility,which can meet the requirements of Baxter for all testing items of rubber stoppers and all the requirements of the national YBB standard.
Unique, stable and highly automated chlorination process ensures the uniformity of chlorination and ensures the high-speed online rate of the Suzhou plant
Special vulcanization and treatment process ensures the stability and drug compatibility of the stopper, and conforms to the biological safety and toxicological properties