ISO 11137 Method 1 / Method VDmax25
Regardless of the amount of Gamma radiation used to irradiate a product, there is always a finite probability that a micro-organism will survive. In order to market a medical device as "sterile", it is necessary to prove that the required amount of radiation is sufficient to reduce the number of contaminating organisms to a level where only one item in a million is likely to have a viable micro-organism present. This is known as a Sterility Assurance Level (SAL) of 10 –6.
We can perform two different techniques to validate the sterilisation process:
- - ISO 11137 Method 1 Dose Setting. The specific dose of radiation needed to sterilise the product is found.
- - ISO 11137 Method VDmax25 kGy Substantiation. The standard dose of radiation used by irradiation plants for routine irradiation is 25 kGy. We perform a study to prove that this dose of radiation is sufficient to sterilise the product.
We can perform the entire ISO 11137 sterilisation validation process in-house. This includes:
The microbiological work performed in the laboratory.
The irradiation exercise using our on-site Gamma irradiation plant operated by Swann Morton (Services) Ltd.
Issuing a detailed report containing the test methods, results and certificates.
We can offer a very rapid and cost effective service as the laboratory and irradiation plant are located on the same site.
Swann Morton (services)Ltd. can routinely irradiate your product once the sterilisation validation is complete.