It is important to maintain and clean the sterile pharmaceutical manufacturing clean room area periodically. Area should be clean after a defined period as per standard operating procedure.
Where sanitation is done by using the disinfectants, two or more disinfectants should be used. Disinfectants may be ineffective against some of the organisms called resistant organisms. A procedure should be developed to identify such organisms and any effective disinfectant should be employed for such organisms.
Sanitation procedure and the disinfectant used should be validated. If any equipment is sanitized with the disinfectant, a cleaning validation should be done for the removal of the disinfectant. Residues of the disinfectant should be removed properly from the equipment after cleaning.
Class A and class B area of sterile manufacturing should be sanitized with the sterile disinfectants and detergents. Generally disinfectants are sterilized by filtration using 0.2 µ membrane filters in sterile conditions. Hold time period of diluted disinfectant should be validated.
Different types of disinfectants should be used in the rotation. Disinfectants should include the sporicidal because most of the disinfectants do not have sporicidal activity and effectiveness of these disinfectants must be validated.
Fumigation of the sterile area is a useful way to sanitize the air of sterile area. It can reduce the microbial contamination in the air. Time of the fumigation can be validated for better results of fumigation. Area should be de-fumigated properly before use. Hydrogen peroxide solution with silver chloride is used in fogger for fumigate the controlled areas. It is available in market with different brand names.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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