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The single lot release is
becoming the more popular option for start-ups desiring to test
their device in the field. Usually a small number of devices are
designated for a specific clinical evaluation--numbers usually range
between 5 and 200, although no specific number of devices are required to perform
this service. Since the devices will be used on humans, they need to
be processed with enough evidence to substantiate that they are safe to use
from a sterility stand-point as well as being free from process-related residuals.
The
batch release option includes everything you need to label the
device as sterile.
What's included: Protocol generation, bioburden testing,
sterilization, product sterility testing, bacteriostasis
and fungistasis testing, BI placement and incubation, device ETO and
ECH residual testing, post-sterilization pouch tensile strength
testing. All data is collated, bound and tabulated and delivered to
you for signing once the project is completed.
Single-lot or batch release sterilization runs are
usually completed in 3 to 4 weeks. The image below demonstrates the
typical process time-line.
Benefits: Single-lot processes are beneficial because they can
be completed in half the time of fully validated cycles and at less than 50% of the cost. Furthermore,
it is common for devices to undergo some
level of redesign before they are ready for commercial distribution;
this allows modifications to be made without having to revalidate the
process.
The number of devices
required for testing varies depending on the starting size of the
batch or lot. Devices marked for testing can be returned, but cannot
be used for human use. Some tests do not require the actual device to be
tested--only the outer pouch. For these devices, we can use dunnage
(product-like) devices that are similar in size / composition (this
often saves the client money).
40
devices would require 12 working devices for test purposes PLUS 10 dunnage
devices (product-like devices)
100 devices would require 24 working devices for test
purposes PLUS 10 dunnage devices
500 devices would require
45 working devices
for test purposes PLUS 10 dunnage
devices
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