Complimentary SOP

QUALIFICATION OF DISINFECTANT AND STERILANT VENDORS

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1.0 Purpose: To identify and qualify vendors that distribute disinfectants or other chemical germicides that possess non-toxic, non-corrosive,broad (efficacy) spectrum, cleaning properties so as to control bioburden levels within the facility. To use a chemical germicide possessing the aforementioned properties as the primary germicidal agent (or agent of choice).

2.0 Scope: The disinfectants or other chemical germicides are to be used in the manufacturing and laboratory areas of the facility, including Clean rooms, industry, hospitals and dental operatories.

3.0 Background: Microorganisms are a natural element of manufacturing environments and of personnel (human flora). Control of microbial levels is a cGMP requirement in the pharmaceutical industry and is an appropriate platform for other settings such as industries, hospitals and dental operatories. The use of"one-step" cleaner disinfectants, agents that clean surfaces and simultaneously inactivate microorganisms in the presence of organic load such as blood, are ideal agents to use in controlling facility bioburden levels. The product - as a cleaning agent - physically removes organisms during the cleaning process. The product - as an antimicrobial agent - chemically inactivates organisms that are not physically removed during the cleaning process. In the event that microbial levels are not kept in a state of control,the use of an alternative disinfectant agent or a sterilant is appropriate. The environmental monitoring program, including the frequency and type of sampling,established limits with rationale, and actions taken should the established limits be breached, should be discussed in a separate procedure. The continuous rotation of anionic and cationic disinfectants, or a disinfectant-sterilant rotation is not recommended because of the build-up of chemical incompatibilities which may alter the effectiveness of the (established)chemical germicidal product.

4.0 Definitions

Disinfectant: A chemical germicide that is registered with the US EPA and local state EPA's where product is sold, e.g. California EPA, Department of Pesticide Regulation;whose label claims (safety and efficacy) are substantiated by the EPA, and whose manufacturer is officially registered with the US EPA. It inactivates vegetative-state microorganisms associated with the plant environment and personnel. It does not achieve sterility because of a lack of complete efficacy against endospores. Contact periods are measured in seconds to minutes.

Sterilant: A chemical germicide that is registered with the US EPA and local state EPA's where product is sold, e.g. California EPA, Department of Pesticide Regulation; whose label claims (safety and efficacy) are substantiated by the EPA, and whose manufacturer is officially registered with the US EPA. It inactivates vegetative-state and endospore-state microorganisms associated with the plant environment and personnel. It therefore achieves sterility. Contact periods are measured in hours. It is used to lower/control spore counts and/or as a corrective action following the occurrence of an environmental out-of-specification result.

4.1 Disinfectant Types: Quaternary ammonium compound; Phenolic

4.2 Sterilant Types:Sodium hypochlorite; acid

Note: Select one disinfectant as the "primary disinfectant" for use on environmental surfaces such as walls, floors, equipment.

5.0 Procedure

5.1 Determine if the manufacturer (or establishment) is registered with the US EPA. Obtain documentation and review.

5.2 Determine if the product's label is officially registered with the US EPA, and whether the efficacy claims can be substantiated. Obtain documentation and review.

5.3 Determine if the prospective vendor (i.e., manufacturer) has (EPA-accepted) data on file indicating antimicrobial efficacy against organism types that can be found in pharmaceutical manufacturing or other institutional settings, e.g.,