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
$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.