AAMI 11137

MD&M Texas

MDM_Seminar_Event_imageNelson Laboratories will be exhibiting at the MD&M Texas show, May 7-8, 2014, at the Fort Worth Convention Center in booth #523.

Presentation: Medical Device Sterilization: Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels of Bioburden Excursions

During the two-day conference and showcase Martell Winters, Senior Scientist at Nelson Laboratories, will be presenting a Learning Lab on Thursday May 8th from 10:00- 11:45 am. He will be presenting Medical Device Sterilization: Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels and Bioburden Excursions to help manufacturers understand sterility assurance and bioburden data. Of interest to medical device manufacturers is the “absolute” necessity of a 10^-6 sterility assurance level (SAL), use of “less-than” values with bioburden data and properly establishing alert and action levels. These topics are applicable to all forms of sterilization (e.g. ethylene oxide, radiation, etc.) and all product types, but are of special interest to combination products, biologics and tissues.

Register now for this exclusive event.

If you can’t make the Learning Lab presentation, Mr. Winters will also present at the Tech Theater on Wednesday May 7th from 1:00-1:30 pm on “Updates to the Bioburden Standard ISO 11737-1; Significant Additional Guidance. P.S. What Happened to the Microbiologists?”. If you would like to meet one on one with Mr. Winters, he will be available in the Nelson booth for FREE consulting sessions, a $500 value. Availability will be determined on a first come, first served basis. If you would like to reserve a time for a consult in advance, please email mpizzi@nelsonlabs.com.

Below are topics that Mr. Winters will be available to discuss at MD&M Texas:

  • Radiation sterilization
  • Selection of SAL
  • Aseptic Processing
  • Evaluating of bioburden data
  • Bioburden alert and action levels
  • Environmental monitoring
  • Manufacturing microbiology

Don’t forget to stop by booth #523 to speak with Nelson representatives.

Fort Worth Convention Center
1201 Houston St.
Fort Worth, TX 76102
Booth #523

Increase Efficiency by Combining Bioburden and Tests of Sterility

By Sean Shepherd, Sr. Study Director, Bioburden, BS, SM/RM(NRCM)Bioburden-testing

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.