Our sterilization services

 
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EO exposure only

Send us your product and we will run it through a cycle. This option is not intended for devices to be used on humans in a healthcare setting. It can be used by any facility wanting a sterile device but without a sterile label claim. It is commonly used by and for labs, researchers, animal studies, DNA-free requirements, biocompatibility studies, etc.

Qualified cycle

A process designed for reusable medical devices that require high-level disinfection or sterilization. The qualified cycle is designed to sterilize reusable devices that have already been cleaned and packaged and are easier to sterilize than devices with lumens with an ID of ≥1mm and ≤5ft in length, or an ID of ≥0.4mm and ≤15 inches in length.

Validated exposure

For devices requiring a sterile label claim used in the human healthcare market. We will perform a turnkey validation—this includes the protocol, manage and run the study, establish a suitable process challenge device, coordinate bioburden, bioburden recovery, product sterility, B/F, EO residual, and LAL testing, and generate a final report and process specification.

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Lot release for new devices

A “mini” validation for a single lot of devices is usually used for animal or human clinical studies where the device is still in its evaluation phase of development. The small lot release allows devices to be labeled as sterile. It is specific for a lot of devices processed in the study—it cannot be used for future processing.

Pricing and turnaround time

 Sterilization fees start as low as $350 per run (with no hidden fees).

24-hour turnaround time. Most small loads are processed the day they arrive and ship the following day.

What’s included in the price?

 
24-hour turnaround available

24-hour turnaround available

Includes BI testing

Full Q.C. paperwork/cert.

No hidden fees & no minimums

Starting from only $350

Starting from only $350

  • Creating a custom sterilization agreement and process specification

  • Assigning a unique sterilization control number for each new lot of devices

  • Examine packaging for suitability/damage before processing (when possible)

  • Placing an ePCD (external process challenge device) or BI into the sterilization load

  • Preconditioning (optional-no charge)

  • Sterilization record, including lots numbers of all sterilization consumables used in the process

  • Graphical printout and summary data for preconditioning, sterilization, sterilant removal, aeration, and BI incubation

  • Biological and Dosimetric results demonstrating cycle lethality

  • Packaging the sterilized load into the original shipping box with a protective sterilized liner bag

  • No hidden shipping handling fees (only the courier quoted rate/or client uses their courier account)

  • 20-point quality control parameter checklist (signed and co-signed by experienced sterilization engineers)

  • Issuance of a final certificate of release

 

Available 7-days a week

If you are in a rush, we will work for you over the weekend, we even have the option of receiving and shipping on Saturdays.