This case has also pushed the concept of cold chain to the forefront of people's minds, so what options should we choose for the transportation of our IVD products? What are the principles of choice and the regulations to be followed? In particular, the cost constraints to prepare for the use of "ice packs + foam box" transportation, how can we comply with the situation? In this article, I'm going to sort it out with all my comrades.
First of all, review a few concepts related to the cold chain
Cold chain management of medical devices : in the process of transportation and storage in accordance with the instructions and labeling requirements for refrigeration, freezing management of medical devices.
Cold chain staff : engaged in the cold chain management of medical devices, receiving, inspection, storage, inspection, out of the warehouse, transportation and other work personnel. The training, assessment and qualification can be on duty
Cold chain facilities and equipment : cold storage (cold storage or freezer) and refrigerated trucks or refrigerated containers (warming box). According to the product variety and specifications to choose
Cold storage and refrigerated trucks in the "Medical Device Cold Chain (Transportation, Storage) Management Guidelines" are very clear requirements, and third-party validation is relatively mature, this article will be pressed for the time being, we focus on the requirements of the thermal insulation box above.
Thermal insulation box should be equipped with cold storage (heat) agent and insulation device , and in line with the product specification and labeling requirements for storage and transportation. Thermal insulation box should be equipped with automatic temperature recording and storage of instrumentation . The incubator and temperature measurement system should be validated before use, periodic validation and out of service time exceeding the specified time limit in the case of validation .
Hardware coolant and recorders can be prepared on their own, then we focus on the key requirements of the validation of the insulation box
1. Establishment and formation of validation management documents: validation program, applicable standards, validation reports, evaluation, deviation handling and preventive measures.
2. Program design: according to the validation object to determine the reasonable duration of continuous validation to ensure that the validation data is sufficient, effective and continuous.
3. Equipment: Verification of the use of temperature measurement equipment should be calibrated by a qualified measuring organization or verification, calibration or verification certificate (copy) should be used as a verification report of the necessary accessories.
4. Data: verification data should be true, complete, valid and traceable.
5. Specification: According to the parameters and conditions determined by the verification, the development of protocols, correct and reasonable use of relevant facilities and equipment.
1. responsibilities;
2. product range;
3. to take into account the variation of environmental factors, including the worst-case scenario;
4. batch: at least one batch is selected for simulated transportation
5. temperature control;
6. acceptable standards to be achieved;
1. the program to be followed;<
2. Batches involved;
3. All results obtained;
4. Data analysis;
5. Acceptable standards to be passed/failed;
The same need for cryogenic preservation of the product, the different manufacturers and products on the requirements of the storage conditions are varied, the following we look at the three.
A: clearly described type
B: reserve the right to explain type
C: do not talk about the transportation type
Thus, it seems that each company has its own considerations and evaluation of the verification, the output of the different storage conditions required, we have to combine more in the process of the actual operation of the enterprise operating model, the performance of the product and the reality of the situation and so on to make it clear.
An overview of the details is as follows: