Stainless Steel Container with USP Class VI Certified Gasket Material

Definition of USP Class VI

USP (United States Pharmacopeia) Class VI is a standard used to determine the suitability of plastic materials intended for use as containers or accessories for non-oral formulations.

Among these, CLASS VI is considered the most stringent standard among classes 1 through 6.

Biocompatibility of Materials

Materials that comply with USP Class VI are designed for use in medical devices that are expected to remain in the body or come into contact with living tissues, necessitating high biocompatibility.

This standard includes being non-microbial, non-cytotoxic, and conforming in animal testing.

Enhanced Safety with USP Class VI Gaskets

By using gaskets certified to USP Class VI, you ensure high compatibility for containers or accessories for non-oral formulations. This enhances the safety and quality of products in pharmaceutical factories.

During product manufacturing or storage in pharmaceutical factories, it ensures the safety of products that might be retained in the body or come into contact with living tissues.

Benefits in Pharmaceutical Manufacturing

Using gaskets with high biocompatibility and safety reduces the risk of cross-contamination of products in pharmaceutical factories.

Utilizing gaskets that meet the strict standards of USP Class VI instills confidence in the safety and reliability of products in pharmaceutical factories, ultimately improving the final product quality.

This empowers pharmaceutical factories to strengthen their competitiveness in the market.

Important Disclaimer

Please be advised that while the gasket material itself has received certification, the molded gasket as a product has not been certified.

It’s crucial to differentiate between the certification of the raw material and the final molded product.