Processing & Sterilization
The processing and manufacturing steps followed at HC Biologics are designed to maximize the gift of donation as well as producing the most advanced medical devices in osteosynthesis fields, while assuring the safety of the end-user by providing safe and sterile tissue and medical devices. Each stage of the process has been designed and validated to ensure patient safety.
- All tissue is processed in certified ISO Class 1000 and Class 100 clean rooms
- All medical devices are processed in certified ISO Class 1000 clean rooms
- All tissue and medical devices are tracked from the very first step until they are delivered to the final user.
- HC Biologics allografts are terminally sterilized via low dose gamma irradiation. The dose used to sterilize all tissues has been determined by performing a VDMAX validation and is verified on a quarterly basis. (All allograft tissue has a *Sterility Assurance Level (SAL) of 10-6)
* To assess the effectiveness of any sterilization process, scientists use a unit of measure called sterility assurance level, or SAL. This figure expresses the probability of a single item in a batch being non-sterile after being subjected to a sterilization process. An effective process has a very low SAL, meaning that there is an extremely small likelihood of any infecting microbes surviving the sterilization.
For example, if a sterilization method has an SAL of 10-3, which means there is a 1 in 1,000 chance of an organism surviving the sterilization process. SAL of 10-6 indicates a 1 in 1,000,000 likelihood of an organism surviving to the end of the sterilization process. SAL is used in the sterilization industry because the ultimate goal is to have the lowest probability, or 10-6, of non-sterile units.
SAL likelihood of surviving organisms
10-1 = 1:10
10-2 = 1:100
10-3 = 1:1,000
10-4 = 1:10,000
10-5 = 1:100,000
10-6 = 1:1,000,000