Hard surface disinfectants monograph

This monograph applies to antimicrobial products which are classified as disinfectant drugs and specifically to products which are intended to be used as environmental hard surface disinfectants in health care facilities, food processing plants and/or domestic dwellings. The medicinal, i.e., active ingredients and their concentrations in Category IV products are restricted to those specified in this monograph. The medicinal, i.e., active ingredients should be identified on product labelling by the names given in Table 1 of this monograph (both preferred names and synonyms are considered acceptable).

This monograph does not apply to:

1. disinfectant products to be used on critical or semi-critical medical devices or instruments, including contact lenses (ref. to Category IV product monograph for contact lens disinfectants);
2. to products with claims for efficacy against:
   • spores, as a sporicide, or as a sterilant
   • pathogens, as a high-level disinfectant
   • Mycobacterium species, including M. tuberculosis
   • the Human Immunodeficiency Virus (HIV)
   • the Hepatitis B and C Viruses (HBV and HCV)

1. All medicinal (active) and nonmedicinal (inactive) ingredients and finished product, should as a minimum meet the specifications of Schedule B or equivalent standard. In the absence of a Schedule B standard, testing should be adequate to demonstrate the product's identity, potency, purity and quality.

1. Single medicinal ingredient categories
   1. Quaternary ammonium compounds
   2. Phenolics
   3. Iodophors
   4. Chlorine releasing compounds

   A list of acceptable single medicinal ingredients for Category IV hard surface disinfectants is provided in Table 1.

2. Combinations of medicinal ingredients
   • Combinations of any of the medicinal ingredients from the same category are permitted provided that the total in-use concentration of the combined ingredients is at the minimum stated in section IV) d) iv).
   • Combinations of any of the medicinal ingredients from different categories listed in Guidance are permitted provided that the ingredient(s) from one of the categories is present at the minimal in-use concentration as stated in section IV) d) iv), and that the ingredients do not interact in a manner that reduces the disinfectant activity.
3. Nonmedicinal ingredients

   Nonmedicinal ingredients should be restricted to the substances that are necessary for the formulation. Their concentration should not exceed the minimum required to provide their intended effect. Their presence should not adversely affect the efficacy or safety of the medicinal ingredient(s) and they should not interfere with assays and tests for the medicinal ingredients.

1. This monograph describes the requirements that are specific to hard surface disinfectant drug products. Other requirements described in the Food and Drugs Act and Regulations should also be met.
2. Unacceptable claims

   Statements such as non-toxic, non-irritant, safe, non-caustic, harmless, etc., are not considered appropriate for disinfectant drugs.

3. Indications

   All products should indicate:

   1. for use in a health care facility (e.g, hospitals, dental clinic, nursing homes), a food processing plant, a commercial setting (i.e., schools, offices), and/or a residential home (i.e., domestic settings); and
   2. one or more of the following as applicable to the product:
      1. disinfectant / disinfectant cleaner
      2. kills bacteria (bactericide)
      3. kills viruses (virucide)
      4. kills fungi (fungicide)
4. Directions for use
   1. For all products complete directions for use as a disinfectant for inanimate environmental surfaces including:
      • types of surfaces (e.g, floors, walls, countertops);
      • specific instructions for the preparation of the in-use dilution in metric units of measure;
      • mode of application;
      • a contact time of 10 minutes if the product is to be rinsed or wiped off;
      • a warning to the effect that all surfaces and/or objects coming in contact with children at the mouthing stage of development, are to be rinsed.
   2. The following additional statement should be indicated if the product is to be used in a food processing establishment:
      • All surfaces that come into contact with food are to be rinsed with potable water after disinfection.
        
        Note: For disinfectants containing only chlorine-releasing medicinal ingredients, a rinse is not required if used at a concentration = 200 ppm.
   3. The following additional statement should be indicated if the product contains phenolic compound(s) and is for use in health care facilities:
      • not to be used in hospital nurseries.
   4. In-use solution concentrations
      1. Quaternary ammonium compounds = 450 ppm
      2. Phenolics = 700 ppm
      3. Iodophors = 30 ppm
      4. Chlorine = 100 ppm
   5. Warnings and first aid information
      1. For all products, warnings, precautionary statements and first aid information should be appropriate to the hazard.
      2. For products intended to be used in food processing plants, the following statement:
         • avoid contamination of food.