The Operation Process for Grading and Coding of Blood Glucose Test Strips and Printing Code

1.Grading Operation

1.1The ambient temperature is controlled at 25℃±2℃, and the relative humidity (RH) is controlled at 40 ~ 80%.

1.2Prepare 5 blood glucose testing instruments and the quality control fluid with the concentration of 5.6mmol/L.

1.3One plate as grading plates is randomly drawn from every 100 plates and change them as the grade of the 100 plates. All the grading plates are collected and cut into single pieces. Each plate was tested for 3 times with a quality control liquid of 5.6mmol/L, the test data are recorded and the average value of each plate of each concentration is calculated, the deviation ofeach test values must be less than 15%. If a plate is not qualified, one piece is extracted again in the 100 plates. The 100 plates will be discarded when three plates are unqualified in a row. The sample of plate test strip after cuttingcan be used for the coding, the retention samples and the stability test. If there is only one code per batch of more than 300,000 batches for three consecutive batches, the step (grading step) can be omitted and the code program can be directly entered.

2.Coding operation

2.1The average value of the test data is taken as a whole, and the deviation between the average and the total average is ±5% as the 1 level, the deviation is from 5.1 to 15% as the 2 level, and the deviation is from -5.1 to -15% as the 3 level, analogously; Then the same rank is placed together.

2.2The same level of plates is merged, and the test strips are extracted from the test strips of the same level after the merger(it is best to disperse in different self sealed bags). In accordance with the linear test method of the blood glucose(Electrochemical Method), 7different concentrations of blood glucose detection current (10 times per concentration ) are tested, and the precision and linear equation for test strips are calculated, the linear equation is the initial code  of this level test strip, and the test strips with same initial codeare collected together. The extra data after sampling is used for testing and retention test.

2.3Test method and result determination:

Precision and accuracy test methods: 100 specimens of the same grade are randomly selected for the fingertip blood test or venous blood test (the concentration of covered glucose is at 1.1 t~2.7、2.8 ~ 4.3、4.4 ~ 6.7、 6.7 ~11.1、11.2 ~ 16.6、 16.7 ~ 22.2 and22.3~ 33.3mM, all 7 samples, and each sample is tested 10 times). The rest of the 30 test strips are used for retention. In comparison with Roche's excellent test strip, the correction code is modified to ensure the accuracy of the test strip to meet the requirements, and the modified code is the final code.

3.Printing operation for the code

3.1 The inspection before working

3.1.1 Inspect and confirm that the operator have already worn the clean clothes, shoes and hats before entering the job.

3.1.2 Inspect and confirmthat no previous production (previous) such as the remaining articles, documents and records in the production post.

3.1.3 Inspect and confirm that the production facilities, production equipment and tools for production are clean and within the validity period.

3.1.4 Inspect and confirm that the production equipment is in good condition and the empty machine is running normally. Equipment selection: oven, manual screen printing machine.

3.1.5 Inspect and confirm that the temperature and relative humidity of the operation room meet the temperature and humidity control requirements by this process.

3.1.6 Operator inspects and confirms that all the inspection before working has been completed and fill in the production record after meeting the requirements. After meeting the requirements from the QA check, the production license can be issued, the product variety status sign can is changed and the production record can is signed and confirmed. Otherwise, it is not allowed to start work until it meets the requirements after redefining or correcting.

3.1.7 All operating procedures: the oven standard operation, cleaning and maintenance operation procedures; manual screen printing standard operation, cleaning and maintenance operation procedures.

3.2 Material preparation

Tie: according to production instruction get the PET test strip, code table, carbon paste, net plate required from the thermostat cabinet in advance, and check the name, number, quantity, quality state and so oncorrect, after ensuring accurate, sent them to the temporary storage room through the logistics channel.

Agitation of carbon pulp:stirmanual the carbon slurry for 5~10 minutes before printing, and check whether the carbon slurry is stirred evenly. If there is still a block phenomenon, keep stirring until the carbon pulp is stretched to make sure that the carbon slurry is stirred evenly.

3.3 Code table for checking (resistance bar corresponding to the final code table)

Print the corresponding resistance patt