Types of Disinfectants Used in Pharmaceutical Industry


Many disinfectants are used alone or in combinations (e.g., hydrogen peroxide and peracetic acid) in the health-care setting. These include alcohols, chlorine and chlorine compounds, formaldehyde, glutaraldehyde, ortho-phthalaldehyde, hydrogen peroxide, iodophors, peracetic acid, phenolics, and quaternary ammonium compounds. Commercial formulations based on these chemicals are considered unique products and must be registered with EPA or cleared by FDA. In most instances, a given product is designed for a specific purpose and is to be used in a certain manner. Therefore, users should read labels carefully to ensure the correct product is selected for the intended use and applied efficiently. Cleaning and disinfection of surfaces are essential steps for maintaining the cleanliness of pharmaceutical manufacturing operations. The USP, for example, requires stringent procedures to be followed during the manufacture of pharmaceutical preparations (as stated in USP Chapter <797>).1 One step towards achieving microbial control within a cleanroom is the use of defined cleaning techniques for walls, ceilings, floors and surfaces at working height together with the application of suitable detergents and disinfectants.

When cleaning rooms the equipment used (mops and buckets) should be of an appropriate design for the grade of cleanroom. When undertaking cleaning a strict cleaning regime should be followed. Cleaning and disinfection using cloths and mop heads is ideally performed by saturating the cleaning item and wiping the area using a series of parallel, overlapping strokes (with an approximate one quarter overlap) and never in circular motions. The direction of the cleaning should be towards the operator (from top to bottom, from back to front). Only one application of the disinfectant or detergent should be applied to avoid over concentration. Cleaning and disinfection should begin with the visually ‘cleanest’ area first and towards the ‘dirtiest’ area last. A disinfectant is a chemical substance or compound used to inactivate or destroy microorganisms on inert surfaces. Disinfection does not necessarily kill all microorganisms, especially resistant bacterial spores; it is less effective than sterilization, which is an extreme physical or chemical process that kills all types of life. Disinfectants are generally distinguished from other antimicrobial agents such as antibiotics, which destroy microorganisms within the body, and antiseptics, which destroy microorganisms on living tissue. Disinfectants are also different from biocides—the latter are intended to destroy all forms of life, not just microorganisms. Disinfectants work by destroying the cell wall of microbes or interfering with their metabolism. It is also a form of decontamination, and can be defined as the process whereby physical or chemical methods are used to reduce the amount of pathogenic microorganisms on a surface

A chlorine releasing agent, such as a ready-to-use disinfectant based on ClO2, is chosen after evaluating its suitability for the relevant surfaces. The efficacy of the disinfectant is assessed via EN13697 carrier test method under simulated practical conditions in order to define the effective contact time against Bacillus pumilus spores.

Once the effective condition has been found, a validation plan is proposed in order to monitor in situ the efficacy of the updated disinfection process, i.e. elimination of Bacillus pumilus spores contamination.



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