T/CPAPE 01-2022
The Manufacture of Sterile Products Using Blow-Fill-Seal Technology (English Version)
- Standard No.
- T/CPAPE 01-2022
- Language
- Chinese, Available in English version
- Release Date
- 2022
- Published By
- Group Standards of the People's Republic of China
- Status
- 2024-06
- Replace By
- T/CPAPE 01-2023
- Latest
- T/CPAPE 01-2025
- Introduction
BFS technical standard framework and core requirements
"General Technical Requirements for the Production of Sterile Products Using Blow Fill Seal (BFS) Technology" (T/CPAPE 01-2022) is the first BFS technology-specific standard in China. It systematically standardizes the technical requirements for the entire process from equipment selection to quality management. The standard integrates international advanced experience such as USP and PDA, and proposes highly operational implementation specifications based on the characteristics of China's pharmaceutical industry.
Equipment Type Process Characteristics Cycle Time Contamination Risk Level Open Parison BFS Equipment Parison Cutting Exposure 10-20 sec Medium-High Enclosed Parison BFS Equipment Fully Enclosed Operation 2-10 sec Low
Key Process Control Elements
1. Construction of Sterility Assurance System
Article 6.2.1 of the standard clearly stipulates that open parison equipment must be equipped with a Class A air shower system, and the integrity of its high-efficiency filter should be verified regularly. In actual application, an ophthalmic preparation company achieved compliance through the following measures:
- Use 0.5μm cartridge filter to maintain positive pressure at the filling point
- Install a pressure differential online monitoring and alarm device (warning value ≥10Pa)
- Perform a smoke test every 6 months to verify the airflow organization
2. Special requirements for process validation
Article 7.5.3 points out that the BFS process validation needs to pay attention to:
- Verification of the maximum continuous operating time (recommended ≥240 hours)
- Simulation of the minimum container opening size
- Evaluation of the impact of mold temperature on heat-sensitive products
Implementation of quality risk management
Chapter 9 of the standard establishes a risk control model based on the life cycle:
Phase Key Points of Risk Control Tool Application Design and Development Plastic Granule Migration Assessment FMEA Analysis Equipment Confirmation Extruder Temperature Parameter Boundary Confirmation DOE Experiment Production Operation Parison Cutting Particle Monitoring Statistical Process Control
Industry Implementation Recommendations
Technology Upgrade Path
In view of the implementation difficulties of existing enterprises, it is recommended to advance in stages:
- Primary stage: Improve the environmental monitoring system (such as adding online particle monitoring for air shower)
- Intermediate stage: Establish a mold maintenance database (record the association between wear cycle and sealing performance)
- Advanced stage: Deploy MES system to realize automatic parameter release
Standard development trend
With the popularization of multi-layer co-extrusion technology, the following may be added to the standard in the future:
- Barrier layer material compatibility test method
- Co-extrusion process parameter verification guide
- Interlayer adhesion strength test standard
T/CPAPE 01-2022 Referenced Document
- GB/T 1.1-2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents
T/CPAPE 01-2022 history
- 2025 T/CPAPE 01-2025 Medicinal centrifugal vibration dryer
- 2024 T/CPAPE 01-2024 Technical Guide for contamination control strategies in aseptic drug production
- 2023 T/CPAPE 01-2023 Remote Maintenance System Guide for Using Blow-Fill-Seal Technology
- 2022 T/CPAPE 01-2022 The Manufacture of Sterile Products Using Blow-Fill-Seal Technology
