IN-PROCESS CHECKS DURING COMPRESSION BY IPQA PERSONNEL
In-process checks during compression by QA
The IPQA person is responsible for performing the in-process checks at a predetermined frequency along with the production personnel to ensure quality products are consistently produced. As you know pharmaceutical products need more control than any other industrial products because these are produced to cure, diagnose, and prevention of diseases.
The following in-process checks shall be performed by IPQA during compression
- Group weight
- Hardness thickness and diameter
- Disintegration test
- Friability test
- Physical appearance check
Group weight is taken by weighing the weight of 20 tablets recording their weight through print and checking the obtained value is within the adjustment range.
Weight, Hardness, and thickness can be tested either by automatic or manual process by using instruments like Pharma test apparatus and Kilian RQ100 Check weigher, Rockwell hardness tester etc. here 20 tablets are tested for weight, hardness, thickness and the obtained test results are compared with the target and limit values of respective parameters.
Disintegration Test is performed using disintegration apparatus by taking 6 tablets and placing them in the tubes after the temperature is attained 37 degrees Celsius in the medium. then the apparatus is run until the tablets disintegrates and the disintegration time is noted and compared with the set limits, the test fails if the DT time is out of limits.
Friability test is performed by taking tablets with unit weight equal to or less than 650 mg, take sample weight near to 6.5 g equivalent and run the apparatus for 4 minutes i.e. 25 revolutions for 4 minutes by placing the tablets in friability apparatus and run the test and after completion of the test , dedust and note the final weight. formula is initial weight minus final weight divide by initial weight multiplied by 100 gives the percent friability. The weight loss should not be more than 1 percent or according to the limits
Physical appearance – this test is done to check the tablets visually for any defects like illegible debossing, any black particles, surface deformities, chipping, capping and lamination, rough surface etc.
These are the in-process checks performed by IPQA personnel during compression.