Test
Services
Sterility
Testing - USP <71>
MicroMed performs sterility testing of devices
and solutions in compliance with USP<71>.
MicroMed performs all tests in a state of the
art Class 100 Clean Room in the confines of a
biological safety cabinet to reduce the risk of
false positives. Our technicians use only sterile
gowning supplies and monitor the CER routinely
to ensure that it is operating within specifications.
Bacteriostasis/Fungistasis testing
is performed in compliance with USP <71>
to validate that samples do not possess antimicrobial
activity that may cause false negatives in sterility
samples.
All EtO sterilization related
spore strips are processed as soon as possible
priority items upon receipt because we know your
timelines are important for lot release. We can
also verify the manufacturer’s population
claim for spore strips.
Sterilization
Validation
| Test
Code |
Test
Description |
Minimum
Sample Requirements |
Turnaround
time |
| ST-001 |
Bacteriostasis/Fungistasis,
USP Method |
Per
USP or ISO depending on lot size Chart
Based on chamber size per ISO 11135 Chart |
3-5 days |
| ST-002 |
Direct Transfer Method-per
device or solution |
14 days |
| ST-003 |
Direct Transfer Method-Spore
Strips |
7 days |
| ST-004 |
Growth Promotion Test-of
Cultured Media |
3-5 days |
| ST-005 |
Autoclave Cycle |
7-9 days |
| ST-006 |
Direct Transfer-Biological
product |
7-9 days |
| MF-001 |
Manipulation Fee-section
or disassembly of sample |
Immediate |
|
