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 different techniques to validate the sterilisation process in compliance with ISO 11137 and ISO 11737 standards:
- ISO 11137 Method 1 Dose Setting. The specific dose of radiation needed to sterilise the product is found.
- ISO 11137 Method VDmax 25 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.
- PD CEN ISO/TS 13004:2014 Sterilization of healthcare products – Radiation. Substantiation of selected sterilization dose: Method VDmaxSD. The sterilization dose can be selected at 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy.
The bioburden and sterility methods used are accredited by UKAS to ISO / IEC 17025:2015.
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.
At the end of the process, a detailed report containing the test methods, results and certificates will be generated.
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.
91°µÍø (Microbiological Laboratory Services) Ltd can offer this service to customers based in the UK and internationally.
