T/CPAPE 01-2023 Active Group standards

T/CPAPE 01-2023 BFS Remote Maintenance System Guideline

Publish Date: 2023-12-01 Implement Date: 2024-06-01 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/CPAPE 01-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine, health, and labor protection

ICS Name: Medical and Health Technology (Vocabulary)

Publish Date: 2023-12-01

Implement Date: 2024-06-01

Scope

Scope: This guide aims to guide BFS users in establishing a remote maintenance and repair system for BFS equipment (including on-site maintenance), with the following key objectives: ensuring operational safety and information security during project implementation; conducting acceptance, verification, and evaluation after BFS equipment maintenance; and obtaining approval before resuming production. This guide can also provide guidance or reference for the following activities: enterprise-independent maintenance of BFS equipment, FAT, SAT, and remote maintenance of other aseptic manufacturing technology equipment. Main Technical Content: 1. Preface 2. Scope 3. Referenced Documents 4. Terms and Definitions 5. Abbreviations 6. Establishment of the BFS Remote Maintenance System 7. BFS Remote Maintenance Service Contract 8. Basic Acceptance Standards for BFS Equipment Maintenance 9. Training Related to BFS Remote Maintenance Activities 10. Application and General Management of BFS Equipment Spare Parts 11. Remote Maintenance of BFS Equipment 12. Expansion of Remote Technical Services Appendix 1/2: Schematic of the Enterprise's Internal BFS Remote Maintenance System Appendix 2/2: Basic Content of the Remote Maintenance Service Contract