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There are 5 things that you have to know about the performance validation of medical temperature control facilities.

"Medical products cold chain logistics temperature control equipment verification performance verification technical specification" national standard is to be implemented in May 1st, is engaged in the medical cold chain logistics work, is the get to the key point in the standard? Today, Xiaobian takes you to talk about those things in the standard.
 
"Performance validation" definition
The test, verification and documentation of the facilities, systems and equipment that have been installed can be effectively stabilized (reproducible) in accordance with the approved production methods and technical requirements of the product.
 
1 things
The operating points of the performance confirmation of the temperature control warehouse
The principle of distribution of 3.3.1 temperature distribution test:
A) synchronize the distribution points in the warehouse to ensure the synchronization and effectiveness of data collection.
D) special area should be set up temperature monitoring points, including air conditioning or refrigeration equipment back air position, temperature automatic monitoring system point terminal installation position, door, window, lamp and other locations.
E) temperature monitoring points shall be laid in the goods or goods may be stored in the location.
3.3.4 open test should ensure that the doors open, there are several doors should be tested one by one.
3.3.5 for equipment failure or power insulation test, due to the high temperature risk, can inspect equipment shutdown, the temperature of the fastest measuring point is close to the length of temperature control limit (as from 5 C to 7 degrees centigrade), then deduce the temperature time limit, as the performance confirmation result.
When 3.3.9 is verified regularly, full load performance should be /confirm/ied. The full load capacity is 70%.
 
2 things
Key points for the performance confirmation of temperature controlled vehicles
The principle of distribution of 4.3.1 temperature distribution test:
B) uniform distribution, usually according to vehicle length and effective volume integral 2 or 3 level layout.
D) temperature monitoring points should be placed in the location wher goods may be stored.
4.3.4 door test shall ensure that the door is fully open and the vehicle equipped with air curtain machine should be opened at the same time.
4.3.7 full load test uses the simulation of the loading situation, should be as close as possible to the storage state of the goods when the vehicle is used, in order to obtain the comparability of the air distribution in the carriage.
Full load performance should be confirmed when 4.3.9 is verified regularly. The loading rate is higher than 70%.
4.3.10 after the temperature of the refrigerated vehicle reaches the specified temperature and is stable, the effective and continuous data acquisition time should be determined according to the longest transportation time of the vehicle, and should not be less than 5h.
 
3 things
Performance confirmation of refrigerating box or incubator. Part of operation points.
5.3.1 static simulation performance validation
5.3.1.1 according to the scope of application of the refrigerator or incubator, the temperature characteristics of different seasons in the actual transportation lines, and the probability of the occurrence of extreme conditions, the static simulated transport temperature verification conditions are set up, including the stage of the drug transportation, the temperature and the duration of each stage, etc.
5.3.1.4 refrigerators or incubators should be placed in simulated objects, and its heat capacity characteristics should be basically consistent with the heat capacity characteristics of the total transport drugs.
Performance confirmation of 5.3.2 dynamic actual line
5.3.2.1 selects the dynamic verification line according to the application range of the refrigerator or the thermal insulation box, the temperature characteristics of the actual transportation lines in different seasons, and the probability of the extreme conditions. The line covers at least the longest transportation time or the most severe temperature condition.
5.3.2.3 confirms the performance of the three seasons in winter, summer and spring and autumn.
 
4 things
The performance of temperature monitoring system is /confirm/ied.
6.3.1 should export at least three different time periods of temperature data for verification.
6.3.2 should use human body or other heat source to change the temperature of the terminal of the measuring point, triggering the alarm and confirm whether the alarm function meets the requirement.
6.3.5 should check whether to backup data on another independent computer or storage device.
6.3.6 should verify the capacity of uninterruptible power supply, confirm that it can supply power for the whole monitoring system. All functions of data acquisition, storage and alarm can be realized under power failure.
 
Source: concom Logistics

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