Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-026.00 Effective date: mm/dd/yyyy
Approved by:
45.3.2 l eak t eSt
1. Carry out the leak test at the start of the sealing operation on 10 blisters/strips coming out
from sealing blister machines.
2. If the leak test fails, all the strips/blisters sealed by that time should be destripped/
deblistered by the packaging department.
3. If the problem occurs continuously, then repeat the leak test till the sealing is satisfactory.
4. Carry out the leak test during and at the end of the strip/blister sealing process by collecting
samples randomly from the lot stripped/blistered.
5. Check each strip pocket visually and decide the disposition as per the attached acceptance
plan of reduced inspection.
6. If the lot fails in the leak test, ask for 100% inspection and collect the samples again
randomly from the inspected lot and decide the disposition as per “A. Normal Inspection—
Single Sampling Plan”; Refer to Annexure III.
7. Inform the packaging manager immediately in case of any anomaly or deviation.
8. Perform the leak test as per SOP No. QAS-000.
45.4 reason for revision
First time issued for the ABC Pharmaceutical Company.
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