Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-017.00 Effective date: mm/dd/yyyy
Approved by:
If an individual bottle content is less than that specified in the MPI and in-process control speci-
fications, then ask the operator to adjust the machine and collect eight bottles from the bottles filled
since the last check, and check the volume again.
None should be less than the specified limits. If this criterion is not met, then quarantine the por-
tion since the last check and inform the packaging supervisor to take the necessary corrective
action.
Note:
For pre-set and action limits, refer to packaging in-process control specifications and MPI.
Removal torque checks
During filling operation, check the removal torque of PP capped sealed bottles.
1. Collect five capped bottles from the filling line.
2. Check the torque individually on a standard torque test.
3. Fix the bottle on the torque tester. Hold the cap of the bottle and apply force gently in the
anticlockwise direction.
4. Monitor the dial of the torque tester while applying torque.
5. Note the reading when the cap slips on the bottle.
Leak test: Refer to SOP No. ABC-000 for leak test procedures.
Action limit
For the action limit, refer to the acceptance plan attached.
1. If in-process control checks cross the cumulative acceptance limit in the first check, then
ask the operator to adjust the machine and resample and check again.
2. If two successive checks for torque cross the cumulative acceptance number, the units
packed since the last check by the line supervisor must be quarantined, resampled, and
inspected again and if they still cross the acceptance number, then quarantine for 100%
inspection and inform immediately the packaging supervisor for the necessary corrective
action and note down the findings on the liquid filling control chart.
Standard average removal torque
1. 28 mm PP caps
NLT 3 lbs.-in.
36.4 reason for revision
First time issued for the ABC Pharmaceutical Company.
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