Biomedical Engineering Reference
In-Depth Information
LEVEL 3
SOP No.: QAS-032
Issued on:
Revision No.:
Initiator name:
Hold time (if any):
Type of container/closure to be used:
Line speeds
Low
Normal
High
Media or placebo materials to be used:
Environmental reports of the system during the test:
No. box and tray:
Remarks on the media fill process:
Verification of medium sterility:
Result of growth promotion test:
Incubator identification:
Incubation time:
Incubation temperature:
results
time inspection of filled units
1st day
7 days
10 days
14 days
Number of units incubated
Number of units rejected (damaged
container)
Number of units rejected (defective seal
container)
Number of units positive
Interpretation of results:
No. of vials with microbial growth
×
100
The % of contamination
=
No. of vials filled - No. of damaged vials
=
%
The acceptable percentage of contamination is ≤ 0.1%.
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