The Rotation of Disinfectants Principle: True or False? - Pharmaceutical Technology

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The Rotation of Disinfectants Principle: True or False?
The author defines sanitizers, disinfectants, and antibiotics, and examines the question of whether the rotation of disinfectants is scientifically warranted.


Pharmaceutical Technology
Volume 33, Issue 2, pp. 58-71

Conclusion

Reduced susceptibility to a disinfectant does not mean that the agent or the disinfection method fails. Most of the evidence for resistance to disinfectants, antiseptics, and sanitizers is laboratory-based. Little, if any, evidence has been gleaned from real-life situations. Resistance in laboratory situations means reduced susceptibility.

Common disinfectants, antiseptics, and sanitizers are used at high concentrations in real-life to attain swift microbicidal action and produce effects such as disruption of the cellular membrane or wall, inactivation of critical enzymes, and degradation of DNA or RNA. At lower concentrations, these substances inhibit microorganisms' growth.

Rotation of disinfectants in the pharmaceutical and biotech industries has been promoted to prevent the development of bacterial resistance. The argument is that one disinfectant should be replaced by another that has a different mode of action. This recommendation is derived from experience with antibiotics that does not apply directly to disinfectants, antiseptics, and sanitizers. The reported resistance to common disinfectants does not occur at use concentrations, and is more accurately considered reduced susceptibility (96, 97).

This assessment agrees with a report issued by CDC on Oct. 28, 1997, which said, "Antibiotic resistant microorganisms are susceptible (or killed) to chemical germicides. The mechanisms by which chemical germicides and antibiotics work are completely different and there does not seem to be a relationship between antibiotic resistance and chemical germicide effectiveness" (98).

Because common disinfectants are used on lifeless objects rather than on living tissue, they are used at concentrations that exceed the MIC or MBC by several orders of magnitude. Consequently, a decrease in susceptibility by a factor of two or more, which is important to an antibiotic, has no relevance to the effectiveness of a common disinfectant.

Rotation of a common disinfectant and a sporicidal helps ensure that bacterial spores do not take hold in manufacturing and aseptic areas. But the rotation of common disinfectants such as those based on phenol-derivatives (except TLN), aldehydes, and oxidizing agents, has no scientific basis. If antibiotic-like disinfectants are used, however, rotation is a necessity.

The development of resistance to antibiotics has been extrapolated to common disinfectants, antiseptics and sanitizers, and the general environment. A misunderstanding of the vocabulary related to disinfectant and antibiotic susceptibility tests seems to be the justification for this extrapolation. The elemental differences between disinfectants' and antibiotics' mechanisms of action and the methods used to evaluate their efficacy are often left unconsidered. The lack of standard terminology for interpreting studies can result in inaccurate interpretations of the data.

José E. Martínez is a consultant at JEM Consulting Services, Box 4956 PMB 652, Caguas, PR 00726, tel. 787.349.3857,

Submitted: Apr. 29, 2008. Accepted: Aug. 3, 2008.




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References

1. P. Gilbert and A.J. McBain, "Potential Impact of Increased Use of Biocides in Consumer Products on Prevalence of Antibiotic Resistance," Clin. Microbiol. Rev. 16 (2), 189–208 (2003).

2. "Annex 1: Manufacture of Sterile Medicinal Products," Good Manufacturing Practice (GMP) Guidelines (Brussels, May, 2003), http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/pdfs-en/revan1vol4_3.pdf, accessed Jan. 18, 2009.

3. FDA, Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice (Rockville, MD, Sept. 2004).

4. FDA, Center for Food Safety and Applied Nutrition, "Comprehensive List of Terms," available at http://www.cfsan.fda.gov/~dms/a2z-term.html, accessed Jan. 18, 2009.


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