GB/T 34399-2017 in English
SUPERSEDEDTemperature control facilities of pharmaceutical products cold chain logistics - Specification for performance qualification
- Issued on:2017-10-14
- Implemented on:2018-05-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$156.00
《GB/T 34399-2017医药产品冷链物流温控设施设备验证 性能确认技术规范》由TC269（全国物流标准化技术委员会）归口，主管部门为国家标准化管理委员会。
Introduction
GB/T 34399—2017 Standard Overview
This standard provides comprehensive technical specifications for the verification of temperature control facilities and equipment in the field of pharmaceutical cold chain logistics, covering all links from temperature-controlled warehouses to refrigerated containers, ensuring that appropriate temperature conditions are maintained during transportation and storage.
Core content structure
| Chapter | Main content | Key requirements |
|---|---|---|
| Temperature-controlled warehouse | Temperature distribution test, measurement point terminal accuracy, extreme environment adaptability | - Temperature deviation and uniformity do not exceed ±3°C - The number of measurement points is not less than 9, with an interval of 5m×2m |
| Temperature-controlled vehicle | Carriage temperature control, measurement point terminal calibration, extreme temperature test | - Temperature stability under full load of cold chain vehicle - The number of measurement points increases according to the volume |
| Refrigerated box/insulated box | Refrigerant configuration, temperature control test, dynamic line verification | - At least 5 temperature recorders - Static simulation time is not less than the longest transportation time |
| Temperature monitoring system | Data acquisition, alarm function, power failure protection | - Update measurement point data every minute - Can still record and alarm in the case of power failure |
Implementation suggestions
1. New facility construction:Plan and construct strictly in accordance with the standards, especially in the layout of measurement points and equipment selection.
2. Existing facility upgrade:Retrofitting is carried out according to standard requirements, especially the calibration of temperature control systems and monitoring equipment.
3. Regular verification:Performance confirmation at least once a year to ensure that the facility continues to meet the specified requirements.
4. Data management:Establish a complete data management system to ensure data security and traceability.
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