Bioburden
Testing - ISO 11737-1, USP <1231>
MicroMed tests for product bioburden to help establish
sterilization validations accordance with ISO11737
and as part of in-process checks to help clients
ensure their production processes are not compromising
sterilization validations. In addition, MicroMed
tests water samples for bioburden to ensure that
water systems are performing within the required
specifications.
| Test
Code |
Test
Description |
Minimum Sample Requirements |
Turnaround
time |
| BI-001 |
Aerobic Bacteria |
Per
related validation documenting
ISO 11137 n=10 or based on client sampling
plan |
7-9 days |
| BI-002 |
Aerobic & Fungi |
7-9 days |
| BI-003 |
Aerobic & Spore |
7-9 days |
| BI-004 |
Aerobic, Spores & Fungi |
7-9 days |
| BI-005 |
Bioburden Validation-Spore
Inoculation |
Sampling
plan based on intended use. |
7-9 days |
| BI-006 |
Bioburden Extraction Efficiency-Exhaustive
Rinse |
7-9 days |
| BI-007 |
Bioburden-Direct Filtration
(100ml sample required for water) |
7-9 days |
| BI-008 |
Blender Method |
7-9 days |
|
