350 rub
Journal №2 for 2015 г.
Article in number:
Comparative study of media for medicines sterility testing
Keywords: nutrient media sterility limit of detection incubation conditions
Authors:
O.V. Gunar - Dr.Sc. (Pharm.), Head of Laboratory of Microbiology, Research Center for Examination of Medical Products (Moscow). E-mail: gunar@expmed.ru
N.G. Sakhno - Ph.D. (Parm.), Leader expert of Laboratory of Microbiology, Research Center for Examination of Medical Products (Moscow). E-mail: nadine87@inbox.ru
M.V. Roshchina - Microbiologist, Laboratory of Microbiology, Research Center for Examination of Medical Products (Moscow). E-mail: roshchina@expmed.ru
Abstract:
The article presents the comparative study of nutrient media used for medicines sterility investigation. The analysis of documentation, regulating features of sterility testing (such as medium, microorganism and incubation temperature) was performed. The most common media were defined and experimentally compared. Strains of aerobic and anaerobic bacteria, yeast and moulds were used. It was established that thioglycolate medium allows to detect a single cell of microorganism and the most proper media for fungi detection are Sabouraud broth and modified Martin medium in case of incubation at (22,5 ± 2,5) оС.
Pages: 3-8
References

  1. Final report and executive summaries from the AOAC International Presidental task force on best practices in microbiological methodology. AOAC International. 2006. 201 p.
  2. Bugno A., de Jesus Andreoli Pinto T. The influence of incubation conditions in sterility test // PDA Journal of pharmaceutical science and technology. 2003. Vol 57. № 6. P. 399-403.
  3. Sutton S. The sterility tests. Rapid sterility testing // J. Moldenhauer (ed). 2011. PDA/DHI Publ. P. 7-24.
  4. Difco & BBL Manual, 2nd Edition. 2009.
  5. Polyak M.S., Suxarevich V.I., Suxarevich M.E'. Pitatel'ny'e sredy' dlya mediczinskoj mikrobiologii. SPb. NICF. 2003. 148 s.