|
US$289.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 34399-2025: Temperature control facilities validation for pharmaceutical products cold chain logistics - Technical specification for performance qualification
Status: Valid GB/T 34399: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 34399-2025 | English | 289 |
Add to Cart
|
3 days [Need to translate]
|
Temperature control facilities validation for pharmaceutical products cold chain logistics - Technical specification for performance qualification
| Valid |
GB/T 34399-2025
|
| GB/T 34399-2017 | English | 199 |
Add to Cart
|
3 days [Need to translate]
|
Temperature control facilities of pharmaceutical products cold chain logistics -- Specification for performance qualification
| Valid |
GB/T 34399-2017
|
PDF similar to GB/T 34399-2025
Basic data | Standard ID | GB/T 34399-2025 (GB/T34399-2025) | | Description (Translated English) | Temperature control facilities validation for pharmaceutical products cold chain logistics - Technical specification for performance qualification | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 55.180.99 | | Word Count Estimation | 14,120 | | Date of Issue | 2025-08-01 | | Date of Implementation | 2025-08-01 | | Older Standard (superseded by this standard) | GB/T 34399-2017 | | Issuing agency(ies) | State Administration for Market Regulation, Standardization Administration of China | GB/T 34399-2025: Temperature control facilities validation for pharmaceutical products cold chain logistics - Technical specification for performance qualification
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT34399-2025
ICS 55.180.99
CCSA80
National Standard of the People's Republic of China
Replaces GB/T 34399-2017
Verification of temperature control facilities and equipment for cold chain logistics of pharmaceutical products
Performance Verification Technical Specifications
Released on August 1, 2025
Implementation on August 1, 2025
State Administration for Market Regulation
The National Standardization Administration issued
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces GB/T 34399-2017 "Technical Specification for Validation and Performance Confirmation of Temperature Control Facilities and Equipment in Pharmaceutical Logistics" and
Compared with GB/T 34399-2017, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) The definition of “performance confirmation” has been changed (see 3.1, 2.1 of the.2017 edition), and “temperature controlled cabinet”, “refrigerated box”, “insulated box”, “temperature
Terms and definitions of “monitoring system” (see 3.2, 3.3, 3.4, 3.5);
b) Added safeguard requirements (see Chapter 4);
c) Deleted the measurement point terminal accuracy test (see 3.1.2 of the.2017 edition) and changed the statement of confirmation under extreme ambient temperature conditions
and content (see 5.1.6, 3.1.3 of the.2017 edition);
d) The description of air conditioning or refrigeration system, the requirements of difference, and the requirements of empty and full load of cold storage and freezer have been changed (see 5.2.1,
5.2.2, 5.2.7, 3.2.1, 3.2.2, 3.2.4, 3.2.8, 3.3.8 of the.2017 edition) added the temperature deviation should not exceed ±3°C
Verification requirements for objects and external ambient temperature to be maintained above 0°C (see 5.2.5, 5.2.6), and the temperature recorder calibration requirements have been deleted.
Requirements, temperature control requirements for extreme environments (see 3.2.3 and 3.2.8 of the.2017 edition);
e) Changed the requirements for the number of uniformity points in temperature-controlled warehouses, the requirements for the locations of multiple measurement points, the requirements for the measurement point terminals and the temperature used for verification
Recorder distance requirements, door opening test method, full load requirements, performance confirmation data collection interval (see 5.3.1b),
5.3.1f), 5.3.3, 5.3.4, 5.3.6, 5.3.8, 3.3.1b), 3.3.6, 3.3.3, 3.3.4, 3.3.7, 3.3.9,
3.3.11], added the requirements for the maximum time of power-off insulation test and the data collection time requirements of non-linked temperature control system (see
5.3.5, 5.3.7);
f) Added content on temperature control cabinet performance confirmation (see Chapter 6);
g) Deleted the terminal accuracy test of the measuring point (see 4.1.2 of the.2017 edition), and changed the description of extreme external environment (see 7.1.6,
2017 Edition 4.1.3) added the requirement for determining the minimum time for pre-cooling (heating) of temperature-controlled vehicles (see 7.1.7);
h) The requirements for difference, description of air-conditioning or refrigeration equipment, and empty and full load requirements for refrigerated trucks have been changed (see 7.2.2, 7.2.4,
7.2.7, 4.2.2, 4.2.4, 4.2.6, 4.3.8 of the.2017 edition), added the object that the temperature deviation should not be higher than ±3℃, and determined
The minimum time requirements for pre-cooling (heating) of temperature-controlled vehicles (see 7.2.5, 7.2.6) have been deleted, and the temperature recorder calibration requirements and extreme environment requirements have been deleted.
Temperature control requirements (see 4.2.3 and 4.2.8 of the.2017 edition);
i) Changed the requirements for the location of measurement points at air outlets and blind spots, the distance requirements between the measurement point terminal and the verification temperature recorder, and the door opening test.
Method, full load requirements, performance confirmation data collection interval [see 7.3.1e), 7.3.3, 7.3.4, 7.3.6, 7.3.8,.2017
Version 4.3.6, 4.3.3, 4.3.4, 4.3.7, 4.3.9, 4.3.11], added the requirements for the maximum time of power-off insulation test, dual temperature control system
Traditional temperature-controlled vehicle verification method (see 7.3.5, 7.3.9);
j) Added performance confirmation requirements for refrigerated containers (see Chapter 8);
k) Added the requirements for distribution testing of refrigerant configuration schemes (see 9.2.1), and deleted the temperature control requirements for extreme environments (see.2017 edition).
5.2.6);
l) Added the requirements for handling simulants without equivalent heat capacity characteristics (see 9.3.1.4), and changed the interval for verification data collection.
Requirements for unpacking and removing simulants (see 9.3.1.5, 9.3.1.7, and 5.3.1.5 and 5.3.1.7 of the.2017 edition);
m) Changed the requirements for actual line performance confirmation and the interval for verification data collection (see 9.3.2.3, 9.3.2.5,.2017 edition)
5.3.2.3, 5.3.2.5), added the handling requirements for simulants without equivalent heat capacity characteristics (see 9.3.2.4);
n) The description of monitoring equipment has been changed (see 10.1.2, 6.1.2 of the.2017 edition);
o) Added requirements for instant messaging, number of test point terminals for refrigerated and frozen medicine warehouses, and requirements for refrigerated and frozen cabinets.
The number of measurement point terminals required for installation [see 10.2.2, 10.2.6e), 10.2.6f)] has been changed for flat warehouses and high-bay warehouses or full
Area requirements for installing measurement point terminals in automated warehouses, independent testing requirements for control systems and monitoring systems [see 10.2.6b]
10.2.6c), 10.2.7,.2017 version 6.2.6b), 6.2.6c), 6.2.7, deleted the temperature error requirements, system power failure, meter
Alarm requirements when the computer is powered off (see 6.2.5 and 6.2.8 of the.2017 edition);
p) Added a method to confirm that the alarm trigger function meets the requirements and a method to determine whether the monitoring system and the control system are not linked
(See 10.3.2, 10.3.4), changed the method of confirming the alarm function and the requirement of daily backup (see 10.3.3, 10.3.6,.2017
(See 6.3.3 and 6.3.5 of the.2017 edition) and deleted the accuracy confirmation requirement (see 6.3.4 of the.2017 edition);
q) Added content on verification methods (see Chapter 11).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed and managed by the National Logistics Standardization Technical Committee (SAC/TC269)
This document was drafted by. China Federation of Logistics and Purchasing, Shanghai Pharmaceutical Logistics Center Co., Ltd., China Logistics and Refrigeration (Chengdu) Certification Service
Co., Ltd., Jiangsu Provincial Center for Disease Control and Prevention, Hangzhou Luge Technology Co., Ltd., Eli Lilly Trading Co., Ltd., Sinopharm Group Pharmaceutical Logistics Co., Ltd.
Co., Ltd., China Resources Pharmaceutical Commercial Group Co., Ltd., Keyuan Xinhai (Beijing) Medical Supplies Trading Co., Ltd., Guangdong Baiyunshan Pharmaceutical Health
Supply Chain (Guangzhou) Co., Ltd., Shenzhen SF Tyson Holdings (Group) Co., Ltd., Shanghai Shengsheng Logistics Co., Ltd., Guangzhou KingMed Medical Testing
Yanyan Group Co., Ltd., Sinopharm Logistics Co., Ltd., China Postal Express Logistics Co., Ltd., Shanghai Baicheng Pharmaceutical Supply Chain
Management Co., Ltd., Kitty Hawk Cold Chain Logistics Co., Ltd., Beijing Zhixiang Lingyu Cold Chain Technology Co., Ltd., Shanghai Siboyuan Cold Chain Technology Co., Ltd.
Beijing Longbang Technology Development Co., Ltd., Beijing Zhengjie Testing Technology Co., Ltd., Beijing Meihao Guanqun Technology Co., Ltd., Zhejiang Provincial Quality
Scientific Research Institute, Shanghai Kaili Transport Refrigeration Equipment Co., Ltd., Qingdao Haier Biomedical Co., Ltd., Zhongke Meiling Cryogenic Technology Co., Ltd.
Co., Ltd., Anhui Zhongke Duling Commercial Electric Co., Ltd., Beijing Yuwei Technology Co., Ltd., Jiangsu Jingchuang Electric Co., Ltd.
Co., Ltd., Copeland Environmental Technology (Suzhou) Co., Ltd., Beijing Jiarui Shifei Refrigeration Equipment Engineering Co., Ltd., Shanghai Kayu Technology Co., Ltd.,
Shenzhen Invke Technology Co., Ltd.
The main drafters of this document are. Qin Yuming, Ren Gang, Guo Wei, Wang Yaping, Wang Xiaoxiao, Chen Yong, He Wangjun, Xu Chao, Zhao Lidong, Hu Changsheng, Chu Chenxi,
Zhuang Jiening, Li Chunbao, Liu Chaojun, Chen Bingyi, Chang Jieying, Yang Qi, Shao Ying, Yu Longfei, Liu Xiaohong, Wang Zhongwei, Zhao Feilong, Li Yanchun, Mei Qian,
Cui Chao, Xu Bo, Chen Jun, Jiang Bin, Wang Shuai, Wang Weikang, Li Qingwen, Wang Xinnan, Liu Linhui, Su Xin, Chen Guoqiang, Li Fanqi, Huang Yi, Li Hao, Liu Yang,
Chang Yangyang.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2017 as GB/T 34399-2017;
---This is the first revision.
Verification of temperature control facilities and equipment for cold chain logistics of pharmaceutical products
Performance Verification Technical Specifications
1 Scope
This document specifies the guarantee requirements for the performance confirmation of temperature control facilities and equipment in the cold chain logistics of pharmaceutical products, temperature controlled warehouses1), temperature controlled cabinets, temperature controlled vehicles
Requirements and verification methods for performance confirmation of vehicles, refrigerated containers, insulated containers, and temperature monitoring systems.
1) Temperature-controlled warehouses include cold storage, freezer storage, constant temperature storage, cool storage, etc.
This document applies to the temperature-controlled warehouses, temperature-controlled cabinets, temperature-controlled vehicles, and cold storage facilities involved in the verification of temperature-controlled facilities and equipment for cold chain logistics of pharmaceutical products.
Activities such as performance confirmation of storage boxes, thermal insulation boxes and temperature monitoring systems.
2 Normative references
This document has no normative references.
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
To confirm that the installed and connected facilities, systems and equipment can operate effectively and stably according to the approved production methods and product technical requirements
Testing, verification and documentation activities performed.
3.2
temperature-controlled cabinet temperature-controlled cabinet
Small storage container with temperature control.
Note. Temperature-controlled cabinets include refrigerators, freezers, etc.
3.3
refrigerator
Insulated box with temperature control function.
3.4
insulated container
The heat-insulating box is made of thermal insulation material.
3.5
It consists of a measuring point terminal, a management host, an uninterruptible power supply and related software, and can collect, display, collect, process, record and alarm in real time.
and systems for transmitting temperature data of pharmaceutical products during storage and transportation.
|