By Sean Shepherd, Sr. Study Director, Bioburden, BS, SM/RM(NRCM)
When it comes to radiation sterilization validation, there is a perception that the bioburden and sterility testing need to be conducted under separate submissions, with results from both then used to compile a statement report by the medical device manufacturer. Nelson Laboratories suggests it is more cost effective and a better use of time to have both tests prepared as a single report at the same time and same location.
As a result, Nelson Laboratories provides a coordination service of the initial bioburden and sterilization validations along with a full validation report. The initial validation is then used as a reference for on-going quarterly dose audits.
The main advantage is that one report covers all areas of the ISO – AAMI 11137-2 standard requirements. Using this combo approach is a much more thorough and economical way to meet the standard.
The bioburden determination provides information on microbial levels of your device before it is sterilized. The test of sterility provides validation of a selected sterilization dose to achieve a 10-6 sterility assurance level for a medical device.
Nelson Laboratories has staff and resources completely devoted to providing the combined service. The package combines four tests into one report and also includes gram stain of the most prominent bioburden organisms, which is important in establishing a baseline if you don’t already have years worth of data.
Using this coordinated service, medical device manufacturers receive all of the results under one report. The report provides bioburden levels and a report of the test of sterility per the guidance outlined in the AAMI/ISO 11137-2 standard. This service is provided for both initial dose substantiation and quarterly dose audit testing. Nelson Laboratories also provides the final report compilation for the manufacturer who generally would have to do it themselves.