USP <1072> - Revision of the Chapter on Disinfection and Antiseptics

USP Chapter <1072> provides useful guidance on the selection and validation of disinfectants and the development of an appropriate concept, especially for companies that are inspected by international authorities such as the US FDA. This chapter has now been revised in several places and new sections have been added.

Content

The chapter deals with the fact that premises used for the manufacture of pharmaceutical products require a suitable cleaning and disinfection program to prevent contamination, both chemical and microbiological. This applies, of course, to both sterile and non-sterile drugs.
The chapter emphasizes that when using disinfectants, care must be taken to ensure that the drug is not contaminated with undesirable chemical ingredients or their residues. Consequently, a cleaning and disinfection procedure should be designed in such a way that it not only prevents microbial contamination, but also ensures that surfaces and/or drugs cannot be contaminated with chemicals or residues.
At this point, it should be emphasized once again that these principles also apply to non-sterile dosage forms, depending on the potential risks, and that further information can be found in the chapter “Bioburden Control of Nonsterile Drug Substances and Products” ?1115? in addition to the present chapter.

Chapter <1072> describes the importance and implementation of cleaning and disinfection in cleanrooms. The aim is to remove residues, particles, and microorganisms from surfaces to enable effective disinfection. Cleaning agents, enzymes, chemicals, and mechanical measures are used for this purpose. A suitable cleaning program is crucial in order not to impair the effectiveness of disinfectants. The chapter covers:

• Selection of suitable chemical disinfectants and antiseptics
• Proof of bactericidal, fungicidal, and sporicidal efficacy
• Use of chemical disinfectants and antiseptics in pharmaceutical GMP environments
• Application of relevant regulations and safety aspects

It does not deal with the formation of biofilms and their relationship to disinfectants and virucidal agents.  The chapter points out that standard works on the topics of  disinfectants and antiseptics can provide additional information.

Changes

The revised draft of <1072> Disinfectants and Antiseptics is based on the official version of the chapter prior to 2013. The proposal published more than two years ago in PF 46(5) has been withdrawn and will be revised based on the comments received. Below is a brief overview of the proposed changes as listed by the USP. They are as follows:

• Remove the “Definitions” section, as definitions and glossary terms related to the microbiology chapters can be found in <1117.1> “Microbiological Chapters-Glossary.”
• Add a section with detailed methods for decontaminating large rooms, including gaseous hydrogen peroxide and chlorine dioxide gas.
• Remove the following sections:
  - Selection of an antiseptic for hand and surgical area disinfection.
  - Theoretical discussion of the disinfecting effect.
• Expand considerations for selecting disinfectants, including bioburden, spectrum of activity, and compatibility with surfaces.
• Add explanations of disinfectant challenge tests, including recommended acceptance criteria.
  - Add a 2-log acceptance criterion for fungal spores.
  - Add smaller coupon sizes (e.g., 1 or 2 cm diameter) for testing the efficacy of disinfectants to simplify efficacy studies.
• Update guidelines for the use of disinfectants in a cleaning and disinfection program, including in situ qualification of disinfectant efficacy and personnel safety.

Further details can be found, upon prior registration, in the chapter draft   <1072> on the USP Webseite.