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Kanglongpharma was founded in 2001 and through 18years of experience,we are now a leading manufacturer of pharmaceutical packing area.We specialize in butyl rubber stopper for blood collection tube,butyl rubber stopper for infusion...

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Pharmaceutical Rubber Stopper Manufacturers

Taizhou KangLong Medical Treatment Technology Co., Ltd.
is founded in 1986

Taizhou KangLong Medical Treatment Technology Co., Ltd established in 2001,is a China Pharmaceutical Rubber Stopper manufacturers and Pharmaceutical Rubber Stopper company,we are now a leading manufacturer of pharmaceutical packing area. We specialize in Pharmaceutical Rubber Stopper, syringe plunger and all kinds of rubber stoppers. To meet the needs of all our highly-valued customers, Kanglongpharma is constantly in pursuit of better quality and higher production efficiency. Designed by GMP Standard, We are equipped with:a 20000-square-meters GMP standard enclosed workshop, a 300,000-grade vulcanizing room, a 100,000-grade trimming room, a 10,000-grade cleaning room, a 100-grade packing room. We specialize in custom Pharmaceutical Rubber Stopper, All kanglongpharma's products are designed and manufactured in accordance to Iso9001-2015 standard.

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Our Recent Update

certificates

We have a number of national patents, we have also passed the ISO9001 quality management system certification, and all our products meet the standards.

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Industry Knowledge Extension

A pharmaceutical rubber stopper is a component used in the packaging of pharmaceutical products, such as vials and syringes. It is typically made of a synthetic rubber material, such as butyl or bromobutyl, and is designed to create a secure seal to prevent contamination and maintain the sterility of the product. The selection and testing of the stopper material is important to ensure it is compatible with the drug product and can withstand the manufacturing process and storage conditions.
Pharmaceutical rubber stoppers are used as closure systems for injectable drug products to maintain product sterility and stability. The primary standards for pharmaceutical rubber stoppers are established by the International Organization for Standardization (ISO) and the United States Pharmacopeia (USP).
ISO 8362 outlines the requirements for rubber closures for injection vials, while USP <381> describes the minimum requirements for rubber closures for containers of injectable drugs.
Pharmaceutical rubber stoppers must meet specific physical, chemical, and biological requirements to ensure compatibility with the drug product and to maintain product integrity throughout its shelf life. These requirements include but are not limited to: dimensional tolerances, extractables and leachables, particulate matter, and biocompatibility.
Proper selection and application of pharmaceutical rubber stoppers are critical to ensure product safety and efficacy. The choice of stopper material and design will depend on the specific drug product, its formulation, and its intended use.
To maintain the quality and effectiveness of pharmaceutical rubber stoppers, here are some tips:
Store in a cool, dry, and clean place away from direct sunlight and heat sources.
Avoid exposure to chemicals and solvents that may react with the rubber.
Use gloves when handling stoppers to prevent contamination.
Inspect the stoppers for discoloration, deformation, or damage before use.
Follow recommended sterilization procedures for the stoppers.
Dispose of any damaged or degraded stoppers.
Keep track of the expiration date of the stoppers and replace them as needed.

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