Microbiologic monitoring areas

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. 

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

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. 

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. 

Production areas where susceptible products are processed should undergo periodic microbiological monitoring. 

Sinks supplied to clean areas should be made of stainless steel and have no overflow, and the water should be of at least potable quahty. Wherever possible, drains in clean areas should be avoided. If installed, however, they should be fitted with effective, easily cleanable traps and with air breaks to prevent backflow. Any floor channels in a clean area should be open, shallow and cleanable and should be connected to drains outside the area. They should be monitored microbiologically. Sinks and drains should be excluded from aseptic areas except where radiopharmaceutical products are being processed when sinks are a requirement. 

Installation and certification of laminar air flow areas where sterile air is provide via high-efficiency particulate air (HEPA) filters Environmental monitoring of the facility, equipment, water, and personnel for strict microbiological and particulate control... 

Siderite is a common mineral in mires, where it is formed through microbiological reduction of iron oxides in the environment. This mechanism may explain its occurrence on artefacts that have lain exposed on the mire surface for a period of time. In these conditions they will be quickly covered by a layer of iron oxides, which will subsequently be reduced to siderite after being overgrown and embedded in an anoxic environment. However, for other artefacts (and modem samples) that have been placed directly under anoxic conditions the siderite must have formed directly from the metallic iron, and here it is still unclear exactly what cathodic reaction is responsible for the oxidation of iron. A Pourbaix diagram based on the actual soil conditions at Nydam is shown in Figure 8. The hatched area in the Pourbaix diagram demonstrates that the pH values found at Nydam are close to the lower limit for siderite stability, so the soil pH is monitored intensively to be sure that no acidification takes place. 

In order to control the microbiological cleanliness of the various grades in operation, the areas should be monitored. 

Cleanrooms and related areas should be monitored at planned intervals for microbiological contamination using one or more of air sampling, settle plates and surface sampling techniques and the results obtained used to determine action levels. 

Processing should be conducted in a deanroom suite, constructed and operated in accordance with the air cleanliness standards. In order to control the microbiological and particulate cleanliness of the various grades/dasses of operation, the areas should be monitored using various methods, e.g., volumetric air sampling, settle plates, surface sampling (swabs, contact plates). 

Areas should be frequently monitored microbiologically by means of settle plates, surface sampling, air sampling or other appropriate methods. The monitoring should be performed while normal production operations are in progress. Records should be retained and immediate remedial action taken as soon as results deviate significantly from those usually found in the area concerned. (See 9.11 and 9.12). 

---