Water testing microbiological

In the case of a closed water system, once the correct water treatment is provided, the incidence of microbiological fouling or corrosion is virtually eliminated, provided that the addition of fresh water is not a frequent occurrence. It is, however, essential to have water tests carried out at regular intervals by a water laboratory. 

WFI and Dl water testing from point of use (microbiological and chemical)... 

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). 

It Is appropriate to increase or decrease sampling based on the trend performance. The time and date will be determined according to the activity. The (specify year) microbiological water testing report, "Water Systems Bioburden and Bacterial Endotoxin Summary Report for Year (specify)," is also included in (provide reference attachment number). 

Water for injection was tested microbiologically for the following and results are found in compliance. 

CIP water was tested microbiologically after completion of cleaning of the following equipment and results were found in compliance. 

Fischer, W. R., Wagner, D. H. X., and Paradies, H. H., An Evaluation of Countermeasures to Microbiologically Influenced Corrosion (MIC) in Copper Potable Water Supplies, Microbiologically Influenced Corrosion Testing ASTM STP 1232, 1994, pp. 275-282. 

In the past, copper was believed to be toxic to most microbiological species. Although this may be true in a test tube under laboratory conditions, it is not generally true in the real world. In this real world, microbial communities excrete slime layers which tend to sequester the copper ions and prevent their contact with the actual microbial cells, Aus preventing the copper from killing the microbes. Many cases of MIC in copper and copper alloys have been documented, especially of heat-exchange tubes, potable water, and fire protection system piping. 

USP 24 Testing Chapters (51) Antimicrobial Effectiveness Testing, (61) Microbial Limit Tests and (71) Sterility Tests, United States Pharmacopeial Convention, Inc., Rockville, MD, 2000. USP 24 Informational Chapters (1116) Microbiological Evaluation of Clean Rooms and other Controlled Environments, (1111) Microbiological Attributes of Pharmaceutical Articles, (1151) Pharmaceutical Dosage Forms, (1225) Validation of Compendial Methods, and (1231) Water for Pharmaceutical Purposes, United States Pharmacopeial Convention, Inc., Rockville, MD, 2000. 

Friedel, R.R., and Cundell, A.M., The application of water activity measurement to the microbiological attributes testing of nonsterile OTC drug products, Pharm. Forum, 25(2) 6087-6090 (1998). 

Dutka, B.J. Nyholm, N. Petersen, J. Comparison of several microbiological toxicity screening tests. Water. Res. 1983, 17, 1363-1368. 

Pellizzari, E. D., L. W. Little, C. Sparacino, and T. J. Hughes, Integrating Microbiological and Chemical Testing into the Screening of Air Samples for Potential Mutagenicity, in Application of Short-Term Bioassays in the Fractionation and Analysis of Complex Environmental Mixtures (M. D. Waters, S. Nesnow, J. L. Huisingh, S. Sandhu, and L. Claxton, Eds.), pp. 331-351, Plenum, New York, 1979. 

Samples for microbiological investigations must be tested within 6 hours of sample collection. For continuous production facilities (minimum 10 working days) water should be sampled at least weekly. For noncontinuous production facilities, water must be sampled prior to each production batch. 

Because microbiological test results from a water system are not usually obtained until after the dmg product is manufactured, results exceeding limits shall be reviewed with regard to the drug product formulated from such water. Consideration with regard to the further processing or release of such a product will depend upon the specific contaminant, the process, and the end use of the product. Such situations are usually evaluated on a case-by-case basis. 

Areas and surfaces in a controlled environment that are in direct contact with products, containers, or closures and the microbiological status of which can result in potential microbial contamination of the product/container/ closure system should be identified. Once identified, these areas should be tested more frequently than non-product-contact areas or surfaces. Elements that are likely critical product contact points may include compressed air or nitrogen, room air, manufacturing equipment, tools, work surfaces, storage containers, conveyors, gloved hands of personnel, and water. 

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