QAS-016 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 318

SOP No. QAS-016.00 Effective date: mm/dd/yyyy
Approved by:

3. Laboratory procedure and limits

Procedure

If the weight of an individual capsule does not meet the action limits, check the separated
portion encapsulated during that period of time in the following way:

i. Collect randomly a sample of approximately 100 capsules from the separated portion.

ii. Out of these 100 capsules, take 20 capsules and weigh. Calculate the average weight

which should be within ±3% of the theoretical weight.

iii. Weigh individually 20 capsules and note down their weights.

Action limits

1. The individual weight of each capsule is between 90% and 110% of the average weight,
that is, ±10% of the average.

2. If not, then individually weigh 20 capsules and keeping their identity, remove the powder
content and weigh them again.

Each individual weight of 20 contents of capsules should be within 90%-110% of the average
weight.

Disintegration test
During the encapsulation process, check the disintegration time at start and twice per shift and note
down the readings on the control chart. Any deviation observed should be entered in the remarks
column of the control chart.

Equipment
Disintegration apparatus with water bath, at 100°C, thermometer.

Procedure

1. Place one capsule each in six tubes of basket and place a disk to each tube with notches
upward

2. Hang the basket in a 1000-mL beaker containing deionized water

3. Start the apparatus

4. Continue the test till all the capsules have disintegrated completely

5. Note the time

Action limits

1. If one or two capsules fail to disintegrate completely within the limit given in SOP, repeat
the test on 12 additional capsules. Not less than 16 out of 18 capsules should disintegrate
completely within the specification limits.

2. If less than 16 capsules out of 18 disintegrate completely within the given time, ask the
operator to separate that portion.

Lock checks
The QAI has to check that capsules are being locked properly by the machine by rotating the two
shells of a capsule in the opposite direction. In a properly locked capsule, they will not slide. Note
down the findings in the control charts.

Length checks
• The QAI has to check whether the length of capsules is as per the speciication or not.
• Note down the indings in the control charts for capsule illing.