BAIJIAN - Third party testing organization
This standard specifies the content、 requirements、 and operational points for confirming the performance of temperature controlled warehouses、 temperature controlled vehicles、 refrigerated boxes、 insulation boxes、 and temperature monitoring systems involved in the cold chain logistics of pharmaceutical products. This standard applies to the performance confirmation of temperature controlled warehouses、 temperature controlled vehicles、 refrigerated boxes、 insulated boxes、 and temperature monitoring systems involved in the storage and transportation of pharmaceutical products. The following terms and definitions apply to this document. 2.1 Performance qualification refers to the testing、 verification、 and documentation conducted to confirm that the installed and connected facilities、 systems、 and equipment can operate effectively and stably (with good reproducibility) in accordance with approved production methods and product technical requirements. 3. Performance confirmation of temperature controlled warehouses 3.1 Content 3.1.1 Confirmation of temperature deviation、 uniformity、 and fluctuation in the storage space of the warehouse (humidity distribution test). 3.1.2 Accuracy testing of temperature automatic monitoring system measurement point terminals. Confirmation of temperature guarantee capability under winter and summer ambient temperature conditions. 3.1.4 Test the operating parameters and usage status of temperature control facilities and equipment. 3.1.5: Confirm the installation position of the measuring point terminal for the temperature monitoring system configuration. 3.1.6 The impact of door opening operations on the temperature distribution in the warehouse. 3.1.7: Determine the insulation performance and trend of the warehouse in the event of equipment failure or external power supply interruption. 3.2 Requirement 3.2.1: Under established operating conditions、 the temperature distribution test results of the air conditioning or refrigeration system in the warehouse should demonstrate that the temperature is controlled within the specified range under both no-load and full load conditions. 3.2.2 Cold points and hot spots should be determined and temperature automatic monitoring system measuring point terminals should be set at the cold and hot spots. 3.2.3 Temperature recorders should be regularly calibrated or verified. The measurement range is between o ℃ and 40 ℃、 and the maximum allowable temperature error is ± 0.5 ℃; The measurement range is between 25 ℃ and 0 ℃、 and the maximum allowable temperature error is ± 1.0 ℃ The difference between the measurement point terminal of the temperature automatic monitoring system and the temperature recorder used for verification should be within ± 1 ℃ (the difference in the freezer should be within ± 2 ℃). 3.2.5 It should be proven that the * short opening time value that causes any measuring point to overheat is greater than the specified value. 3.2.6 It should be proven that the insulation time limit value in the event of equipment failure or external power supply interruption is greater than the specified value
Function of testing report:
1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report
2. Online e-commerce platform entry: Quality inspection report recognized by major e-commerce platforms 3. Used as a sales report: issuing legally effective testing reports to make consumers more confident 4. Papers and research: Provide professional personalized testing needs 5. Judicial services: providing scientific、 fair、 and accurate testing data 6. Industrial problem diagnosis: Verify the troubleshooting and correction of industrial production problemsinspection and testing process:
1. Telephone communication and confirmation of requirements
2. Recommend solutions and confirm quotations 3. Mail samples and arrange testing 4. Progress tracking and result feedback 5. Provide reports and after-sales service 6. If urgent or priority processing is requiredTesting and testing characteristics:
1. The testing industry is fully covered、 meeting different testing needs
2. Fully cover the laboratory and allocate localized testing nearby3. Engineers provide one-on-one services to make testing more accurate
4. Free initial testing、 with no testing fees charged
5. Self service order delivery for free on-site sampling
6. Short cycle、 low cost、 and attentive service 7. Possess authoritative qualifications such as CMA、 CNAS、 CAL、 etc 8. The testing report is authoritative and effective、 and is generally used in China