T/CNPPA 3033-2026 Active Group standards

T/CNPPA 3033-2026 Technical requirement for ready to sterilize rubber closures

Publish Date: 1970-01-01 Implement Date: 1970-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CNPPA 3033-2026

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: \nLogo, packaging, transportation, storage

ICS Name: Pharmaceutical Science

Publish Date: 1970-01-01

Implement Date: 1970-01-01

Scope

This document is applicable to the cleaning of rubber seals (RTS) to be sterilized, and it complies with the requirements for direct contact with drug packaging in sterile drug production. It can directly enter the sterilization process without further cleaning. In the field of sterile drug production, rubber seals to be sterilized serve as the core barrier of the drug packaging system, and their performance is directly related to the sterilization effect, stability, medication safety, and compliance of the drugs. They have been widely used at home and abroad, but there are no clear technical specifications and requirements for cleaning rubber seals to be sterilized, which increases the risk of user selection of this product. Therefore, this document is formulated to complete the cleaning of rubber seals to be sterilized in accordance with the relevant provisions and procedures of direct contact with drug packaging materials in sterile drug production quality specifications, for users to select, evaluate, and audit. It clarifies the key quality attributes and control requirements of this product, and is used to guide both suppliers and buyers to reach consensus on the above-mentioned goals.