Medical Radiology and Radiation Safety. 2013. Vol. 58. No. 3. P. 45–47
RADIATION PHYSICS, TECHNOLOGY AND DOSIMETRY
V.V. Kalashnikov1, E. P. Pavlov1, I.I. Samoilenko2, V.N. Korsunsky1
Individualization of the Sterility Test Duration for Some Irradiated Medical Products
1. Burnasyan Federal Medical Biophysical Center of FMBA, Moscow, Russia, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. ; 2. Gamaleya Institute of Epidemiology and Microbiology, Moscow, Russia
Abstract
Purpose: To study the possibility of shortening the test for sterility of medical products.
Material and methods: We used the methods of research, established the current regulatory documents. Results: In cases of non-sterility of products visual culture growth was observed, usually within the first 3 days of incubation. Control the growth of microcolonies reduced crop growth period of discovery for 1–2 days. After the radiation sterilization process in the surviving microorganisms observed delayed start of growth, the dynamics of the proliferative phase did not change significantly.
Conclusion: These data confirm the possibility reducing the period sterility test for some types of medical products to 7 days.
Key words: radiation sterilization, medical products, sterility control, sterility test duration