The Product Inoculation service provides vaccinated samples or carriers with specific test organisms used to test the ability to sterilize a device for a specific sterilization cycle. This study is useful in R&D and process development of different sterilization methods including ethylene oxide, steam, dry heat, evaporated hydrogen peroxide and other methods. Vaccines can be delivered in a variety of BI configurations such as: commercially prepared sports suspensions, paper strips, discs, wires and stitches. Sites without vaccination usually contain at least one million sports (10 6). Other populations are available on request. Products can be used for research and development cycles, comparative resistance cycles (to determine the most durable product location) or product D-value studies.
The Product Inoculation study involves placing the spores of the appropriate indicator organism at various locations in the device, including those that are considered to be the most difficult to sterilize. Inoculating the real product to its most durable location is the only sure way to determine its sterilization resistance. Any type of product or ingredient can be vaccinated and then sterilized to determine its ability to sterilize the device. Different test organisms and different populations can also be used if desired.
All sterilization standards using the overfill method require the manufacturer to demonstrate that the device has been killed when inoculated with the appropriate indicator organism where it is most difficult to sterilize. The correct organism for ethylene oxide and dry heat is Bacillus atrophaeus, and for steam and vaporized hydrogen peroxide, the indicator organism is Geobacillus stearothermophilus.
EUROLABhas extensive experience in product inoculation and we can use your samples for further sterilization testing in the laboratory or send them back to the customer or directly to the contract sterilizer for validation studies.
Please add the desired BI type and population when submitting samples.
EUROLAB, with its highly expert team and internationally accredited laboratories, Product Inoculation Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
