Journal of The Academy of Clinical Microbiologists

Register      Login

VOLUME 21 , ISSUE 2 ( July-December, 2019 ) > List of Articles

MINI REVIEW

Advantages and limitations of rapid biological indicator for fast sterilisation assurance

Debabrata Basu, Subhas Chandra Bag, Satyam Mukherjee, Gaurav Goel

Keywords : Biological indicator, chemical indicator, physical parameter, rapid auto-reader, sterilisation monitoring

Citation Information : Basu D, Bag SC, Mukherjee S, Goel G. Advantages and limitations of rapid biological indicator for fast sterilisation assurance. 2019; 21 (2):66-69.

DOI: 10.4103/jacm.jacm_20_18

License: CC BY-NC 4.0

Published Online: 17-01-2020

Copyright Statement:  Copyright © 2019; Wolters Kluwer India Pvt. Ltd.


Abstract

Continuous quality monitoring in sterilisation processes is paramount importance for supplying sterile materials to the patients. The sterilisation monitoring is required because early prediction of steriliser malfunctioning is impossible, and malfunction gets detected only when it runs. Internationally there are three types of sterilisation monitoring system such as physical, chemical and biological monitoring. The physical monitoring system is dependent on time, temperature and pressure. The chemical and biological monitoring systems are also dependent on the same physical parameters but in addition require the presence of condensing steam for sterility assurance. The main aim of this article is to elaborate differences between the ‘conventional biological indicator’ and the ‘rapid biological indicator’ with their benefits and disadvantages for biologically proven sterility assurances. However, it is not possible to determine whether biological material in the indicator is alive or dead, visually. The article explains that the detection of living spores can be technically challenging, and each and every step should be monitored carefully because spores are highly resistant to harsh environmental conditions. The results show that proper incubation time in an appropriate growth medium and optimal temperature is the only way to detect the living microorganisms in a biological indicator for proper sterility assurance.


PDF Share
  1. Basu D, Bhattacharya S, Mahajan A, Ramanan VR, Chandy M. Sterilization indicators in central sterile supply department: Quality assurance and cost implications. Infect Control Hosp Epidemiol 2015;36:484-6.
  2. Biological Indicators: Measuring sterilization. Available from: http://202.74.245.22:8080/xmlui/bitstream/handle/123456789/1014/Chapter%2013-Biological-indicators- Measuring-sterilization.pdf?sequence=15. [Last accessed on 2018 May 09].
  3. Neumann O, Feronti C, Neumann AD, Dong A, Schell K, Lu B, et al. Compact solar autoclave based on steam generation using broadband light-harvesting nanoparticles. Proc Natl Acad Sci U S A 2013;110:11677-81.
  4. Live-Imaging of Bacillus Subtilis Spore Germination and Outgrowth. Available from: https://pure.uva.nl/ws/files/2451269/151494_04.pdf. [Last accessed on 2018 May 09].
  5. Setlow B, Korza G, Blatt KM, Fey JP, Setlow P. Mechanism of bacillus subtilis spore inactivation by and resistance to supercritical CO2 plus peracetic acid. J Appl Microbiol 2016;120:57-69.
  6. Vesley D, Nellis MA, Allwood PB. Evaluation of a rapid readout biological indicator for 121 degrees C gravity and 132 degrees C vacuum-assisted steam sterilization cycles. Infect Control Hosp Epidemiol 1995;16:281-6.
  7. Albert H, Davies DJ, Woodson LP, Soper CJ. Biological indicators for steam sterilization: Characterization of a rapid biological indicator utilizing Bacillus stearothermophilus spore-associated alpha-glucosidase enzyme. J Appl Microbiol 1998;85:865-74.
  8. Huesca-Espitia LC, Suvira M, Rosenbeck K, Korza G, Setlow B, Li W, et al. Effects of steam autoclave treatment on Geobacillus stearothermophilus spores. J Appl Microbiol 2016;121:1300-11.
  9. Lukomskaya IS, Voznyi YV, Lanskaya IM, Podkidisheva EI. Use of beta-maltosides (p-nitrophenyl-beta-D-maltoside, 2-chloro-4-nitrophenyl-beta-D-maltoside and 4-methylumbelliferyl-beta-D-maltoside) as substrates for the assay of neutral alpha-glucosidase from human kidney and urine. Clin Chim Acta 1996;244:145-54.
  10. Matsui T, Shimada M, Saito N, Matsumoto K. Alpha-glucosidase inhibition assay in an enzyme-immobilized amino-microplate. Anal Sci 2009;25:559-62.
  11. Setlow B, Korza G, Setlow P. Analysis of α-glucosidase enzyme activity used in a rapid test for steam sterilization assurance. J Appl Microbiol 2016;120:1326-35.
  12. Understanding Biological Indicator Grow-Out Times-Part II. Available from: http://www.pharmtech.com/understanding-biological-indicator-grow-out-times-part-ii [Last accessed on 2019 Jun 10].
  13. Alfa MJ, Olson N, DeGagne P, Jackson M. Evaluation of rapid readout biological indicators for 132 degrees C gravity and 132 degrees C vacuum-assisted steam sterilization cycles using a new automated fluorescent reader. Infect Control Hosp Epidemiol 2002;23:388-92.
  14. Design, Validation and Monitoring of Sterilization Processes and Instrument. Available from: https://www.ciet-bio.com/?forcedownload=1&no_encrypt=1&file=filesystem%2FInstant++BI++CI+Class+5+%D7%95%D7%95%D7%90%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94+.pdf. [Last accessed on 2019 Oct 08].
  15. Guideline for Disinfection and Sterilization in Healthcare Facilities; 2008. Available from: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/sterilizing-practices.html. [Last accessed on 2019 Apr 09].
  16. Ling ML, Ching P, Widitaputra A, Stewart A, Sirijindadirat N, Thu LT, et al. APSIC guidelines for disinfection and sterilization of instruments in health care facilities. Antimicrob Resist Infect Control 2018;7:25.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.