T/CNPPA 3028-2026 Active Group standards

T/CNPPA 3028-2026 Infusion container bioburden control and validation guidance

Publish Date: 2026-02-05 Implement Date: 2026-02-05 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 3028-2026

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Biological products and blood products

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2026-02-05

Implement Date: 2026-02-05

Scope

This document provides a microbiological-based risk analysis approach, methods, and control measures for bioburden control in the process design and R&D phase, daily production, and quality control of infusion containers for pharmaceutical packaging materials enterprises. It also offers a method of reflection on how formulation enterprises can establish control over the bioburden of infusion containers during use. This document not only applies the concepts of the United States Pharmacopeia (USP) <1115> to infusion containers, but also fully reflects the core ideas of process control and risk management in the Good Manufacturing Practice (GMP) for Pharmaceutical Packaging Materials issued by the National Medical Products Administration. It provides more specific methods for bioburden risk control and provides a basic management tool and support for the pharmaceutical packaging materials industry to improve the overall quality level of non-sterile pharmaceutical packaging materials.