All medical devices that are labeled STERILE require validation. Validation is the verification that a specific process will deliver a repeatable state time and time again--in this case, a sterile device without process related residuals. Our validations typically take between 6 and 12 weeks (depending on current workload). Each validated sterilization process is tailored to the device (usually temperature driven). While 50C is the normal process temperature, we can validate processes as low as 30C--this is particularly useful for drug-coated devices or bioengineered materials.

 

 

Once the validation process is complete, our standard sterilization fees apply.

 

All validated devices are required to undergo preconditioning in our controlled preconditioning rooms for at least 12 hours prior to sterilization. Once preconditioning is complete, the devices are sterilized overnight and are usually available for shipping the following afternoon. This equates to only 48 hours within our facility. While the devices can be shipped almost immediately, it takes 48 hours after sterilization for the biological indicators to grow. During this time, the devices need to remain in quarantine until the final release certificate is issued. The diagram below demonstrates a typical process time.

48 hours (includes preconditioning)

Starting from $300 for 2 chambers

 

 

*NOTE: devices can be shipped prior to the 48 hour biological incubation period

 

We have multiple chambers ranging from 33 cubic feet (the size of an oversized freezer) to larger walk-in chambers. Our current processing capacity makes Andersen Scientific the best choice for fast turnaround sterilization, whether you have a single device or several pallets. Because we sterilize in multiple "micro" chambers, customers with single devices are never bumped for larger pallet-sized orders.