The following in process parameters should be checked immediately after the setting of compression machine, after starting of compression, after any break during compression and at intervals specified in BMR.
1.2. The description of the tablets produced should match with the description given in the BMR.
2.2. Calculate the average weight of one tablet by using the formula given below
Average wt. of tablet = Weight of 20 tablets
20
2.3. The average wt. shall fall within % deviation of the weight given in the BMR.
3.2. Place a clean petri dish on the balance and tare it to zero reading.
3.3. Place one tablet at a time in the petri dish and allow the Tablet Autotester system to record the weight.
3.4. In a similar manner place the remaining 19 tablets one by one till completion of weight variation.
3.5. Check the hardness and thickness of the tablet on Autotester
3.6. Check the results on the Autotester sheet with the standards mention the BMR, the results of weight variation, hardness, thickness, diameter shall comply with the results in BMR.
3.7. Detach the sheet from the system and keep it along with the BMR.
4.2. Weigh 20 tablets and record the weight.(W1)
4.3. Place the tablets in the drum of friability test apparatus and set the revolutions to 100.
4.4. Start the apparatus and run for 100 revolutions.
4.5. Take out the tablets leaving aside the broken fragments and remove any dust adhering to the tablets.
4.6. Weigh and record the weight.(W2)
4.7. Calculate the friability value in percentage by using the formula given below
Friability in % = W1 - W2 x 100
W1
4.8. Record the results of the friability test in the BMR.
4.9. The results shall comply with the standard given in the BMR.
5.2. Take DM water in the beaker of disintegration test apparatus such that at the highest point of upward stroke the wire mesh remains at least 2.5 cms below the surface of DM water and descends to not less than 2.5 cm from the bottom of the vessel on the downward stroke.
5.3. Set the temperature to 37° C ± 2° C and allow the water in the beaker to achieve the set temperature.
5.4. Place one tablet in each of the six tubes along with the disc.
5.5. Start the apparatus immediately and note the time at which all the tablets disintegrate (no mass should remain on the mesh of the basket assembly)
5.6. Record the disintegration time in BMR.
5.7. The disintegration time shall comply with the standard given in the BMR.
5.8. All tablets used for in-process testing in the In-process testing area should be discarded in a container of water.
5.9. Tablets used for average weight check and thickness in the compression cubicle have to be reused in the same batch.
5.10. Tablets used for the in-process test like Hardness in the compression cubicle have to be discarded in the container of water.
5.11. In case of tablets falling out of specification in any of the above tests, stop the machine immediately, segregate the tablets, inform quality assurance, rectified the problem, recheck all the above parameters and then proceed further.
5.12. The segregated tablets have to be properly labeled, appropriate action to be taken in consultation with quality assurance and documented.
1. Description
1.1. Check the initial tablets for physical appearance, shape, embossing etc.as given in the BMR.1.2. The description of the tablets produced should match with the description given in the BMR.
2. Average Weight
2.1. Weigh 20 tablets on balance / electronic balance and record the weight in BMR.2.2. Calculate the average weight of one tablet by using the formula given below
Average wt. of tablet = Weight of 20 tablets
20
2.3. The average wt. shall fall within % deviation of the weight given in the BMR.
3. Individual weight variation, Hardness, Thickness, Diameter
3.1. Take 20 tablets for individual weight variation check.3.2. Place a clean petri dish on the balance and tare it to zero reading.
3.3. Place one tablet at a time in the petri dish and allow the Tablet Autotester system to record the weight.
3.4. In a similar manner place the remaining 19 tablets one by one till completion of weight variation.
3.5. Check the hardness and thickness of the tablet on Autotester
3.6. Check the results on the Autotester sheet with the standards mention the BMR, the results of weight variation, hardness, thickness, diameter shall comply with the results in BMR.
3.7. Detach the sheet from the system and keep it along with the BMR.
4. Friability Test
4.1. Take 20 dedusted tablets for friability testing.4.2. Weigh 20 tablets and record the weight.(W1)
4.3. Place the tablets in the drum of friability test apparatus and set the revolutions to 100.
4.4. Start the apparatus and run for 100 revolutions.
4.5. Take out the tablets leaving aside the broken fragments and remove any dust adhering to the tablets.
4.6. Weigh and record the weight.(W2)
4.7. Calculate the friability value in percentage by using the formula given below
Friability in % = W1 - W2 x 100
W1
4.8. Record the results of the friability test in the BMR.
4.9. The results shall comply with the standard given in the BMR.
5. Disintegration Test
5.1. Take six tablets for disintegration testing.5.2. Take DM water in the beaker of disintegration test apparatus such that at the highest point of upward stroke the wire mesh remains at least 2.5 cms below the surface of DM water and descends to not less than 2.5 cm from the bottom of the vessel on the downward stroke.
5.3. Set the temperature to 37° C ± 2° C and allow the water in the beaker to achieve the set temperature.
5.4. Place one tablet in each of the six tubes along with the disc.
5.5. Start the apparatus immediately and note the time at which all the tablets disintegrate (no mass should remain on the mesh of the basket assembly)
5.6. Record the disintegration time in BMR.
5.7. The disintegration time shall comply with the standard given in the BMR.
5.8. All tablets used for in-process testing in the In-process testing area should be discarded in a container of water.
5.9. Tablets used for average weight check and thickness in the compression cubicle have to be reused in the same batch.
5.10. Tablets used for the in-process test like Hardness in the compression cubicle have to be discarded in the container of water.
5.11. In case of tablets falling out of specification in any of the above tests, stop the machine immediately, segregate the tablets, inform quality assurance, rectified the problem, recheck all the above parameters and then proceed further.
5.12. The segregated tablets have to be properly labeled, appropriate action to be taken in consultation with quality assurance and documented.
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