Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-006.00 Effective date: mm/dd/yyyy
Approved by:
B.1
During the filling operation, checks are carried out for the physical attributes of the filled
packs.
Procedure
1. Check cleanliness of the empty tubes fitted with caps.
2. Collect 32 tubes from the filled units on an hourly basis and check the defects of tubes, if
any, such as deshaped tubes, pin holes, dented tubes, improper crimping, and so on and for
broken or cracked caps. If any defective tube is found, inform the supervisor for corrective
action.
3. Enter the findings in a relevant control chart.
B.2 Weight variation checks
Confirm that the machine has been set in limits before the operation by a line boss and machine
operator as per the written procedure.
Procedure
1. Once the machine has been set within limits and the process has been allowed to run, start
collecting the samples on an hourly basis.
2. Weigh the empty tubes on a top pan balance to get an average weight of empty tubes to be
used in the batch.
3. Calculate the gross limits and enter them on the chart.
4. Get the filled tubes directly from the machine on an hourly basis.
5. Weigh the filled tube that should be within limits.
6. Record the results on a control chart and decide disposition as per attached appendix or
product in-process specification (packaging).
B.3 Leak test
During cream/ointment filling operation carry out the leak test at the time of setting or beginning
of the process and at least once in a shift.
Procedure
1. Collect 10 tubes randomly after filling
2. Place the tubes in an oven
3. Close the oven and set the temperature at 60-65°C
4. Keep for 15-20 min or until the contents melt
Action Limit
1. If any leakage is observed out of 10 units, check for reasons of leakage.
2. If leakage happened due to crimping and sealing, cracked cap, without wads, pin holes, and
so on, inform the packaging supervisor for rectifying the anomaly and sorting of already
filled or packed units since the last check.
25.4 reason for revision
First time issued for the ABC Pharmaceutical Company.
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