Microbiology_banner.png

Microbiology of Medical Device

SCR provides product sterility analysis for medical devices at a competitive price. Our tests follows USP and ISO standards to meet producer's requirements.

Bioburden tests determine the total number of viable microorganisms in or on a medical device, container or component. It is performed on any product that requires control and/or monitoring of bioburden counts, usually as part of a sterilization program. This test acts as an early warning system for possible production problems that could lead to inadequate sterilization. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.

Sterility tests must be validated by performing a Method Suitability test (Bacteriostasis/Fungistasis or B/F).

For some sterilization processes, a surrogate product or indicator may be used. Most commonly the use of a biological indicator (BI) or spore strip saves both test time and product cost. BI sterility tests at SCR are performed similar to product sterility but require a shorter incubation time and low volumes of media, allowing for a more cost effective sterility test to verify sterilization load processing.

Test List

Contact Us For A Quote
Test Code
Method Name
Description
Estimated TAT (days)
Test methods (accredited)
MB109a
B&F - 6 Organisms
Bacteriostasis and fungistasis test (6 organism)
5-7 days
MB-BnF
MB100
Sterility - immersion (100 mL)
Sterility test by direct immersion (<100 mL media)
15-20 days
MB-STERIL-1
MB100a
Sterility - immersion (<500 mL)
Sterility test by direct immersion (>100-<500 mL media)
15-20 days
MB-STERIL-1
MB101
Sterility BI
Sterility of Biological Indicator by direct immersion
8-10 days
MB-STERIL-2
MB102
Sterility - membrane
Sterility test by membrane filtration
15-20 days
MB-STERIL-3
MB103
Sterility USP <71> - (100 mL)
Sterility test by USP <71> method (2 media <100 mL)
15-20 days
TP-USP <71>
MB103a
Sterility USP<71> - (>100)
Sterility test by USP <71> method (2 media >100 mL)
15-20 days
TP-USP <71>
MB108
B&F - 3 organisms
Bacteriostasis and fungistasis test (3 organism)
5-7 days
MB-BnF
MB109
B&F - 5 Organisms
Bacteriostasis and fungistasis test (5 organism)
5-7 days
MB-BnF
MB110
Bioburden - membrane - aerobic
Determination of bioburden by membrane filtration (aerobic bacteria+Y&M)
5-7 days
MB-BIOBURDEN-1
MB111
Bioburden - pour plate
Determination of bioburden by pour plate method
5-7 days
MB-BIOBURDEN-2
MB113
Bioburden - aerobic&anaerobic
Total aerobic and anaerobic bioburden by membrane filtration
5-7 days
MB-BIOBURDEN-1
MB114
Bioburden - anaerobic
Total anaerobic bioburden
5-7 days
MB-BIOBURDEN-1
MB115
Bioburden - Total - pour plate
Total aerobic and anaerobic bioburden by pour plate method
5-7 days
MB-BIOBURDEN-2
MB116
BI Population - Etigem
Population determination of biological indicators (Etigem Method)
4-5 days
TM-BI Count
MB117
BI Population - 3M
Population determination of biological indicators (3M Method)
4-5 days
TM-BI Count
MB118
CF - repetitive
Correction factor for bioburden -repetitive extraction
6-8 days
ISO 11737-1
MB119
CF - inoculation
Correction factor for bioburden -inoculation method
6-8 days
ISO 11737-1
Closeup of a Petri Dish
Do not see the test you are looking for?
Contact us at +606-7947 606 
OR
Other Tests 
Closeup of a Petri Dish
Do not see the test you are looking for?
Contact us at +606-7947 606
OR