T/YJC 027-2024 Active Group standards

T/YJC 027-2024 Pill bottle precise filling and dosing system technical specifications

Publish Date: 2024-12-12 Implement Date: 2025-01-01 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/YJC 027-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Comprehensive Pharmaceutical Science

Publish Date: 2024-12-12

Implement Date: 2025-01-01

Scope

Main technical content: This group standard is applicable to fully automatic filling equipment and its supporting systems for pharmaceutical industry vials. In terms of technical requirements, the system consists of modules such as online weighing, filling, central data analysis, rejection and auxiliary systems. Performance indicators include a measurement error of ≤±3% for powder filling and ≤±2% for liquid filling; filling speeds have corresponding requirements under different modes; data processing capabilities include a real-time data collection frequency of ≥100 records/second and sufficient storage capacity; the corking and capping rates should be ≥99.9% and the capping pass rate ≥99.8%; the system's degree of automation should be ≥95% and it should have self-checking and alarm functions for faults; and the cleanliness should meet the requirements of Class 5 clean environment in ISO 14644, and the materials of the components in contact with drugs should comply with relevant regulations.