Follow
International Journal of Current Microbiology and Applied Sciences (IJCMAS)
IJCMAS is now DOI (CrossRef) registered Research Journal. The DOIs are assigned to all published IJCMAS Articles.
Index Copernicus ICI Journals Master List 2023 - IJCMAS--ICV 2023: 95.56 For more details click here
National Academy of Agricultural Sciences (NAAS) : NAAS Score: *5.38 (2020) [Effective from January 1, 2020] For more details click here

Login as a Reviewer


See Guidelines to Authors
Current Issues
Download Publication Certificate

Original Research Articles                      Volume : 14, Issue:11, November, 2025

PRINT ISSN : 2319-7692
Online ISSN : 2319-7706
Issues : 12 per year
Publisher : Excellent Publishers
Email : editorijcmas@gmail.com /
submit@ijcmas.com
Editor-in-chief: Dr.M.Prakash
Index Copernicus ICV 2018: 95.39
NAAS RATING 2020: 5.38

Int.J.Curr.Microbiol.App.Sci.2025.14(11): 195-210
DOI: https://doi.org/10.20546/ijcmas.2025.1411.020


Evaluation of Disinfectants by Surface Challenge test as per USP 1072 standard at Pharma Company Laboratory, India
Infiniti Lines, Mumbai, India
*Corresponding author
Abstract:

Cleaning and disinfection of surfaces are essential steps for maintaining the cleanliness of pharmaceutical manufacturing operations. To validate the efficacy of disinfectants used in disinfection procedure, in order to reduce surface contaminations, we tested invitro the action of commercial disinfectants. Surface Challenge testing has been carried in a Pharmaceutical manufacturing laboratory in accordance with the United States Pharmacopeia <1072> Disinfectants and Antiseptics protocol. Surface Challenge tests assess the effectiveness of the selected disinfectant against surface-adhered microorganisms. The test organisms used include standard strains mentioned in USP <1072>. Our results showed a bactericidal, fungicidal, and sporicidal efficacy coherent to the acceptance criteria suggested by United States Pharmacopeia <1072>. The correct implementation of our cleaning and disinfection procedure, respecting stipulated concentrations and contact times, led to a reduction of more than 4 Log10 for all microorganisms used. The qualification of procedure was carried out on a screening test in order to measure effectiveness of the disinfectants, chosen according to their principle of action.


Keywords: Disinfection, , United States Pharmacopeia <1072>, qualification, Log10 reduction, contamination


References:
  1. Abraham, Z. (2010). Disinfectant Qualification – A Multifaceted Study, Microbiologics.
  2. Rottjakob, D. (2013). Disinfection qualification testing—considerations for the aseptic and cleanroom manufacturing environment.
  3. Russell, Hugo & Ayliffe's, (2004). Principles and Practice of Disinfection, Preservation & Sterilization, 4th ed, Blackwell Publishing, chapter 7: 220 – 237.
  4. Sandle, T. (2016). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms, 2nd Edition, Grosvenor House Publishing: Surrey, UK
  5. Sandle, T. (2017). The European approach to disinfectant qualification, La Vague: 45 – 48.
  6. Severs, Y. D. and Lamontagne, M. C. (2002). A literature review of disinfectants, Technical Report, Defence R&D Canada – Toronto.
  7. Testing of Disinfectants, PharmaState Academy, 2017.
  8. United States Pharmacopeia Forum USP <1116> Microbiological evaluation of clean rooms and other controlled environmets. 2012
  9. United States Pharmacopoeial Convention, Inc. United States Pharmacopeia 28- National Formulary 23. Rockville, MD: US Pharmacopoeial Convention, Inc.
  10. USP General Chapter <1072> “Disinfectants and Antiseptics”, (2017): 3792-3795.
  11. Van Kilgeren, B., Koller, W., Bloomfield, S.F., Bohm, R., Cremieux, A, Holah, J., Reybrouck, G. and Rodger, H-J., (1998). ‘Assessment of the efficacy of disinfectants on surfaces’, International Biodeterioration and Biodegradation, 41:289-296. https://doi.org/1016/S0964-8305(98)00020-1
  12. Vellutato Jr. Developing compliant and effective cleaning and disinfection methodologies in GMP controlled environments. Cleanrooms august, 2006.
  13. Vina, P., Rubio, S. and Sandle, T. (2011). ‘Selection and Validation of Disinfectants’, in Saghee, M. R., Sandle, T and Tidswell, E. C. (Eds.) (2011). Microbiology and Sterility Assurance in Pharmaceuticals and Medical devices, New Delhi: Business Horizon: 219 – 236.
  14. Wilfried, P. (2004). Directory of Microbicides for the Protection of Materials – A Handbook, Kluwer Academic Publishers.

Download this article as Download

How to cite this article:

Imran Memon, Naushin I. Memon, Surjeet Samanta and Rahul Mali. 2025. Evaluation of Disinfectants by Surface Challenge test as per USP 1072 standard at Pharma Company Laboratory, India.Int.J.Curr.Microbiol.App.Sci. 14(11): 195-210. doi: https://doi.org/10.20546/ijcmas.2025.1411.020
Copyright: This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike license.

Citations