Bioburden Testing – ISO 11737-1, USP <1231>
Bioburden testing is performed to determine the total number of viable microorganisms in or on a medical device, container or component after completion of all in-process steps prior to sterilization. Bioburden testing can act as an early warning system for possible production problems which could lead to inadequate sterilization or possible product recall. Bioburden testing is also useful in calculating the necessary dose for effective radiation sterilization, and to monitor product routinely to ensure adequate dosing.
MicroMed tests for product bioburden in accordance with ISO11737. Samples are filtered after being exposed to a detergent, sonicated, incubated and colonies counted. In addition, MicroMed tests water samples for bioburden to ensure that water systems are performing within the required specifications.
Bioburden Extraction Efficiency – ISO 11737-1, USP <1231>
MicroMed tests devices to establish bacterial contamination of a given device. This is done by inoculating a known amount of thermostable bacteria on a given device in triplicate. The bacteria are then extracted, filtered, plated and incubated. Once this is performed the amount of inoculum is counted against the dilution set up to calculate the extraction efficiency factor (EEF) of the given device. This EEF is then used to calculate the actual amount of bacteria present on future bioburden tests.
Water Testing – Bioburdens/Coliforms – ISO 11737-1, USP <1231>
MicroMed can test for bacterial safety of water samples by performing direct filtration of water samples. A kit containing a sterile vial can be provided to collect the water samples. Samples must be sent back to the lab overnight to provide accurate results. MicroMed can perform total heterotrophic testing and total coliform testing.
ANSI/AAMI/ISO 11737 | ANSI/AAMI/ISO 11137 | ISO 11135 | EN 1174 | USP 1231
Turn Around Time (TAT)
|BI-001||Device Bioburden – Aerobic Bacteria||12 – 14 days|
|BI-002||Device Bioburden – Aerobic Bacteria and Fungi – (TSA)||12 – 14 days|
|BI-002A||Device Bioburden – Aerobic Bacteria and Fungi – SDA||10 – 12 days|
|BI-002B||Device Bioburden – Aerobic Bacteria and Fungi – Protocol Specific|
|BI-003||Device Bioburden – Aerobic or Anaerobic Spore (heat shock treatment)|
|BI-004||Device Bioburden – Anaerobic Bacteria and Fungi|
|BI-005||Device Bioburden Validation-Extraction Efficiency – Spore Inoculation Method (per unit)|
|BI-006||Device Bioburden Validation-Extraction Efficiency – Exhaustive Rinse Method (per unit)|
|BI-006A||Additional Rinses (per rinse)|
|BI-007||Liquid Bioburden-Direct Filtration, per sample|
|BI-009B||Bioburden-Selective Media-Mannitol Salt|