Microbiologic monitoring

Stadler H, Skritek P, Sommer R et al (2008) Microbiological monitoring and automated event sampling at karst springs using LEO-satellites. Water Sci Technol 58 899-909... 

As already mentioned, smooth, polished surfaces are cleaned most easily. Floors and horizontal surfaces should be cleaned and disinfected daily, walls and ceilings as often as required, but the interval should not exceed 1 month. Regular microbiological monitoring should be carried out to determine the efficacy of disinfection procedures. Records should be kept and immediate remedial action taken should normal levels for that area be exceeded. 

Microbiological Monitoring of Areas Used for Production of Solids, Semi-Solids, and Liquids... 

Daily microbiological monitoring (commodity washing), room no. and parenteral area WFI inlet and... 

ABC Pharmaceutical Industries routinely monitors the microbial content of the air, inanimate surfaces, personnel, water systems, and product component bioburden. Microbiological monitoring of these areas generally reflects on the efficiency of cleaning and sanitization procedures and employee practices. Continuous environmental monitoring provides the assurance that product is produced by a controlled process that will maximize the sterility and quality of the manufactured sterile product. 

Water systems. The water systems at ABC Pharmaceutical Industries are monitored per manufacturing site SOP for Microbiological Monitoring of Water. The levels of water tested are city water, purified water (deionized water), and water for injection (WFI). Manufacturing site SOP describes the procedures for obtaining samples, sampling frequencies, test procedures, and acceptance criteria (alert and action limits). 

Environmental control program Microbiological monitoring of injectable area Particulate monitoring of injectable area... 

The data of the microbiological monitoring of the sterility testing facility show a fault. 

Procedures used to simulate any steps of a normal production fill Microbiological monitoring data obtained during the media-fill setup and run... 

During each media fill, all major and minor defined interventions will be microbiologically monitored. 

Microbiological monitoring data obtained during the media-fill setup and run... 

The PhRMA Environmental Monitoring Work Group published an article in the March 1997 issue of Pharmaceutical Technology on microbiological monitoring of environmental conditions for nonsterile manufacturing [4]. This publication is a compilation of survey results of nonsterile manufacturing facilities within the United States and recommendations based on the survey results. In this section, a summary of the survey results and recommendations pubhshed in this article are reviewed with a few comments from this author based on experiences in this area. 

Pharmaceutical Research and Manufacturers Association of America (PhRMA) (1997, March), Microbiological monitoring of environmental conditions for nonsterile manufacturing, Pharm. Technol., 58-74. 

Microbiological monitoring, including various types of dip-slides. Frequently plate count and other related monitoring techniques are carried out in a laboratory. 

It is easily understood that if the aseptic operation is performed in a separated small space from which personnel have been completely excluded, the necessity for room classification based on particulate and environmental microbiological monitoring requirements may be significantly reduced. In other words, critical operations in an aseptic area should be performed in the smallest space, and intervention by personnel should be minimized by indirect means through the use of protective glove ports and/or half suits. Application of these methods can minimize the chance of contamination. Following are such systems currently in place to reduce the contamination rate in aseptic processing. 

Perform microbiological monitoring especially when wines from external sources are processed and oak aging is used... 

Levels of viable contamination, however, are of importance in operation. Microbiological monitoring for viable contaminants should be carried out to coincide with routine manufacture with normal levels of dynamic activity. As with traditional aseptic filling. 

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