Biomedical Engineering Reference
In-Depth Information
Attachment II
ABC PHARMACEUTICAL COMPANY
QC LABORATORY
MICROBIOLOGICAL MONITORING
STEAM TESTING REPORT
Sampled from:
Sterile plant
Testing date:
...................
Sampling time:
.....................
Sampled by:
....................
Sampling Point
Total Microbial Count
LAL
Steam
CFU/100 mL
USP EU/mL
xxx
CFU/100 mL
USP EU/mL
xxx
CFU/100 mL
USP EU/mL
Comment :
....................................................................................
Action Limits: TMC: 5 CFU/100 mL
LAL: NMT 0.125 USP EU/mL
Tested by:
Report date:
Checked by: QC manager
QC director
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