Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-009.00 Effective date: mm/dd/yyyy
Approved by:
2. Collect a sample of 32 strips/blisters as they are coming out of the machine.
3. The following defects are to be checked:
a.
i.
Pinholes
ii. Empty pockets
iii. Open strip/blister
b. Leakers
• If any defect is found, inform the packaging supervisor and label the lot with “To
be sorted” labels and ask for 100% inspection.
For checking (b), use the following procedure:
• Performtheleakteston10strips/blisteraspergivenprocedure,tocheckthatno
leakers are present.
• Incaseoffailure,informthepackagingsupervisorandasktosort,destripthestrips
sealed since the last check.
• Entertheindingsonthetabletilling/strip/blisteringcontrolchart.Format
attached.
• Leaktesttobeperformedatleasttwice/shiftbytheQAIandonanhourlybasisby
the packaging line boss.
c. Sealing checks through the aluminum peel-off test
• Afterperformingtheleaktestonblisters,allowthemachinetorun.
• Duringtheblisteringprocess,collectsomesamplesofblistersastheyarecoming
out of the machine and try to detach the aluminum foil from the middle of the
blister to the end.
• ThefoilshouldnotpeeloffeasilyfromthePVC/PVDC.
• Incaseitdoes,informthepackagingsupervisorandsegregatetheportionforsort-
ing and de-blistering.
• Sealingcheckswillbeperformedonanhourlybasis.
Search WWH ::
Custom Search