T/CNPPA 3001-2017 Active Group standards

T/CNPPA 3001-2017 BFS (Blow-Fill-Seal Integrated) Injection Technology Guideline

Publish Date: 2017-01-18 Implement Date: 2017-01-18 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 3001-2017

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: 2017-01-18

Implement Date: 2017-01-18

Scope

This guide specifies the technical content and requirements for infusion production enterprises to produce finally sterilized infusion products using the Blow-Fill-Seal (BFS) technology. The characteristics of the Blow-Fill-Seal (BFS) infusion technology, the Blow-Fill-Seal (BFS) infusion production technology, the raw material particles and sealing system components of the BFS infusion packaging, and the quality characteristics of the BFS infusion.