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Product Inoculation

Product Inoculation

A Product Inoculation test provides inoculated samples or carriers with specific test organisms that are used to test the ability to sterilize a device to a given sterilization cycle. This study is useful for R& D and process development of different methods of sterilization including ethylene oxide, steam, dry heat, vaporized hydrogen peroxide and other methods. Inoculation is performed with different BI configurations such as commercially prepared spore suspensions, paper strips, discs and sutures with 106 spores per location; other populations can be used as well. The products can be used in validation cycles, comparative resistance cycles (to determine the most resistant product location) or in product D-value studies.

Applicable Standards

ANSI/AAMI/ISO 11135    |    ISO 17665

Pricing/Quote

Test Price Request Quote
SPI110 - Sterilization Product Inoculation: B. atrophaeus
Per sample1+$10.00
Add
SPI120 - Sterilization Product Inoculation: G. stearothermophilus
Per sample1+$16.00
Add
SPI130 - Sterilization Product Inoculation: C. sporogenes
Per sample1+$15.00
Add
SPI140 - Sterilization Product Inoculation: Wires
Per sample1+$15.00
Add
SPI150 - Sterilization Product Inoculation: Other Organism/Method
Per sample1+Quote
Add
SPI510 - Sterilization Product Inoculation: Inoculation, EO Exposure and Sterility Testing
Per test1+Quote
Add
SPI110 - Sterilization Product Inoculation: B. atrophaeus
Per sample1+$10.00
SPI120 - Sterilization Product Inoculation: G. stearothermophilus
Per sample1+$16.00
SPI130 - Sterilization Product Inoculation: C. sporogenes
Per sample1+$15.00
SPI140 - Sterilization Product Inoculation: Wires
Per sample1+$15.00
SPI150 - Sterilization Product Inoculation: Other Organism/Method
Per sample1+Quote
SPI510 - Sterilization Product Inoculation: Inoculation, EO Exposure and Sterility Testing
Per test1+Quote

Turn Around Time

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT
SPI110 Sterilization Product Inoculation: B. atrophaeus 11
SPI120 Sterilization Product Inoculation: G. stearothermophilus 11
SPI130 Sterilization Product Inoculation: C. sporogenes 11
SPI140 Sterilization Product Inoculation: Wires 11
SPI150 Sterilization Product Inoculation: Other Organism/Method 11
SPI510 Sterilization Product Inoculation: Inoculation, EO Exposure and Sterility Testing 20
Code TAT
SPI110 11
SPI120 11
SPI130 11
SPI140 11
SPI150 11
SPI510 20

Study Outline

The Product Inoculation study involves placing spores of the appropriate indicator organism in varying locations on the device, including those judged most difficult to sterilize. Inoculating the actual product in its most resistant location is the only definitive way to determine the resistance to sterilization. All types of products or components can be inoculated and then exposed to sterilization to determine the ability to sterilize the device. Different test organisms and different populations can also be used if requested.

All sterilization standards using the overkill method require the manufacturer to demonstrate kill of the device when inoculated in the most difficult-to-sterilize location with the appropriate indicator organism. For ethylene oxide and dry heat, the correct organism is Bacillus atrophaeus and for steam and vaporized hydrogen peroxide, the indicator organism is Geobacillus stearothermophilus.

Nelson Laboratories has extensive experience in product inoculation and can use your samples for further sterilization testing at the lab, or we can ship them back to the client or directly to the contract sterilizer for validation studies.

Please include the desired BI type and population when submitting samples.