Review on Biological Indicator

Author:

Jyoti B. Salgar 1,Sanjay K. Bais 1,Reshma Ankush Mule 1

Affiliation:

1. Fabtech College of Pharmacy, Sangola, Maharashtra, India

Abstract

Biological indicators (BIs) serve as crucial tools in assessing the efficacy of sterilization and disinfection processes across diverse industries, including healthcare, pharmaceuticals, and food. This review examines key features and the significance of BIs, emphasizing their microbial sensitivity, reproducibility, resistance to specific sterilization methods, and distinctive cultural characteristics. The ability of BIs to withstand stringent conditions ensures they accurately reflect the most resistant microorganisms, providing a reliable measure of sterilization effectiveness. In applications, BIs play a pivotal role in ensuring sterilization assurance in medical settings, contributing to quality control in pharmaceutical manufacturing, and safeguarding food safety in the food industry. Their importance in preventing healthcare-associated infections and maintaining product quality underscores their indispensable role in various sectors.[1] The review also highlights emerging trends in BI technology, including integration with sensors for real-time monitoring, the adoption of single-use BIs for convenience and reduced cross-contamination risks, and the customization of BIs for specific sterilization processes. These trends indicate a continual evolution in BI capabilities, enhancing their precision and utility in assessing and validating sterilization procedures. In conclusion, biological indicators are fundamental components of quality assurance programs, offering a reliable means to validate sterilization processes. As technology advances, the integration of BIs with monitoring tools is expected to further refine their accuracy and broaden their applicability across industries.[2].

Publisher

Naksh Solutions

Subject

General Medicine

Reference24 articles.

1. Pflug, I. J., "Textbook for an Introductory Course in the Microbiology and Engineering of Sterilization Processes," rev. 5th ed., Environmental Sterilization Laboratory, University of Minnesota; Minneapolis, MN, 1982.

2. Busta, F. F., Foegeding, P. M., and Adams, D. M., in Sporulation and Germination, American Society for Microbiology, Wasbington, DC, 1981, p. 261.

3. Levinson, H. S., Sonenshein, A. L., and Tipper, D. J. (Eds.), "Sporulation and Germination," American Society for Microbiology, Washington, DC, 1981.

4. Caputo, R. A., Rohn, K. J., and Mascoli, C. C., "Recovery of biological indicator organisms after sublethal sterilization treatment," J. Parenter. Drug Assoc., 34, 394 (1980).

5. Nash, R. A., and Wacher, A. H. (2004) Pharmaceutical Process validation, Marcel Dekker, NY.

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