Microbiological Monitoring of Water

It is the responsibility of following staff to follow the procedure. The quality assurance (QA) manager is responsible for SOP compliance. 

Evaluate and approve the results. Review the trend analysis. 

A formal personnel training program is required to minimize the risk of 

Personnel involved in microbial identification will require specialized training on required laboratory methods. 

Additional training on the management of the water data collected will be needed. 

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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). 

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. 

The chemical and microbiological quality of water used in production should be specified and monitored. Care should be taken in the maintenance of water systems in order to avoid the risk of microbial proliferation. After any chemical sanitization of the... 

In practice microbiological quality of water is monitored by action and alert levels. Thus the user will be early notified about any deviation of critical parameters. For instance an alert level might be put at a factor 10 below an action level. To determine these levels a good set of total viable aerobic counts, endotoxin assay results and TOC assay results should be available. For the collection of these results, particularly in the start-up phase very frequent measurements must be executed. 

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... 

Analysis of waters for viruses is more difficult because of their small size, about 10 to 300 nm average diameter. Also, viruses need susceptible living cells such as chick embryos or tissue cultures for cultivation and identification in the laboratory, which make them more difficult to work with. Nevertheless, viruses represent an important microbiological class for water and wastewater-monitoring programs since serious waterborne diseases such as polio and hepatitis are transmitted in this way. 

Real matrix materials They are rare because often unstable. They serve as external quality assessment materials (proficiency testing) in particular in the field of water monitoring. In food microbiology they are rare or unknown. 

The Directive lays down the organoleptic, physical, chemical, and microbiological requirements to be met by the quality of drinking water. The Directive requires Member States to carry out a regular monitoring of the quality of the water intended for human consumption according to the methods and minimum frequencies of analyses set out in the Directive. 

The chemical and microbiological quality of the water used should be monitored. Water should be of at least potable quality and have an acceptable microbial count. 

Regular monitoring of the process water, including at the point of use, for chemical and microbiological quality. The sample size and test method employed should be capable of detecting the presence of low levels of indicator organisms, e.g. Pseudomonas. 

It is appropriate to monitor and control the microbiological content of the water and other materials used in the leak test procedures. 

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