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