Antimicrobial Efficacy of Selected Disinfectants in the Phar | 56144



Antimicrobial Efficacy of Selected Disinfectants in the Pharmaceutical Manufacturing Environments

Hamza Attia Sadek Mohamed Aboelenin

Pharmaceutical manufacturing takes place within a series of specially controlled environments– cleanrooms. On one level, a cleanroom or clean zone is simply an area that is clean in terms of both particle counts (as defined in the international cleanroom standard ISO14644) and microbial counts (as defined in a second cleanroom standard for biocontamination control, ISO14698.1 In addition, regulatory requirements for cleanrooms are detailed by EU GMP or the FDA guidelines (1) One important step towards achieving microbial control within a cleanroom is the use of defined cleaning techniques, together with the application of detergents and disinfectants. The detergents and disinfectants used in pharmaceutical grade cleanrooms need to be of a high quality and effective at killing micro-organisms. Both correct product selection and cleaning techniques are important, particularly in relation to some of the newer cleanroom technologies (1). A sound cleaning and sanitization program is needed for controlled environments used in the manufacture of Pharmacopeial articles to prevent the microbial contamination of these articles. Sterile drug products may be contaminated via their pharmaceutical ingredients, process water, packaging components, manufacturing environment, processing equipment, and manufacturing operators. Current Good Manufacturing Practices (cGMPs) emphasize the size, de- sign, construction, and location of buildings and construction materials, and the appropriate material flow to facilitate cleaning, maintenance, and proper operations for the manufacture of drug products. When disinfectants are used in a manufacturing environment, care should be taken to prevent the drug product from becoming contaminated with chemical disinfectants as a result of the inherent toxicity the disinfectants (2). The types of detergents and disinfectants used represent an important decision for the pharmaceutical manufacturer there are various different types of disinfectant with different spectrum of activity and mode of action (3) In the few past years there have been a number of advances in clean room technologies that have helped to reduce the risk of contamination and stream line process operations (4). The ultimate assessment of cleaning products and cleaning techniques is revealed through environmental monitoring programs in terms of the number and types of micro-organisms recovered (5.6). Dettol_ is widely used in homes and healthcare settings for various purposes including disinfection of skin, objects and equipment, as well as environmental surfaces. With prior cleaning before application, the number of microorganisms colonizing the skin and surfaces are greatly reduced (Rutala, 1996). The antimicrobial properties of chloroxylenol, the main chemical constituent of Dettol and other chlorinated phenols have been extensively studied (Hugo and Bloomfield, 1971a). The antimicrobial properties of the disinfectant against some pathogenic bacteria have earlier been reported (Mellefont et al.,2003) (7). The aims of this study were to determine the efficacy of a disinfectant (Dettol) on the different surfaces within the production environment of pharmaceutical factories comparing with the also used disinfectants (chlorine, phenol and alcohol).