Microbiological testing

Efficiency testing of high-efficiency partieulate air (HEPA) filters used for the supply of sterile air to aseptie workplaces (Chapter 22) is normally achieved by the generation upstream of dioetylphthalate (DOP) or sodium ehloride particles of known dimension, followed by deteetion in downstream filtered air. Retention efficiency is reeorded as the percentage of partieles removed under defined test conditions. Microbiological tests are not normally performed. 

Each lot of a component, drug product container, or closure that is liable to microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use. 

Monitoring for successful therapy is critical in this serious infection to prevent complications, prevent resistance development, and decrease mortality. Routine assessment of clinical signs and symptoms, as well as laboratory tests (i.e., repeat blood cultures), microbiologic testing and serum drug concentrations, must be performed. 

Bench Space. Adequate laboratory bench, desk, and file space are needed for physical, chemical, and microbiological testing, for documentation, and for storing records, respectively. 

Activities encompassed by the stability program include sample storage of either development or production batches (or both), data collection and storage/retrieval, physical, chemical, and microbiological testing, document preparation of regulatory... 

It is recognized that physical and mechanical properties of a parenteral system affect seal integrity. However, physical and/or microbiological testing approaches may be used to challenge seal integrity or demonstrate that a seal has been achieved and is being maintained over the shelf life of the container system. 

However, in case of acute clinical mastitis, it is widely accepted that animal welfare considerations should take prevalence. If both farmer and veterinarian are not familiar with non-antibiotic treatments, they should be advised to use broad-spectrum antibiotics immediately, because any delay (e.g. the 2-3 days it often takes between diagnosis and the return of microbiological test results) may seriously harm the animal. This approach should, however, only be taken after a sound clinical diagnosis, since antibiotic treatments themselves may lead to dramatic aggravation of the condition. For example, E. coli inflammations are able to develop into severe toxaemia, because increased levels of toxins are released into the animal tissues when E. coli cells are killed or stressed by antibiotic treatments. Also, if yeasts are the main cause or form part of the pathogen complex that causes mastitis, their growth and proliferation may be supported by the administration of anti-bacterial antibiotics (Crawshaw et al., 2005). 

The evaluation of patients treated for IE includes assessment of signs and symptoms, blood cultures, microbiologic tests (e.g., MIC, minimum bactericidal concentration [MBC], or serum bactericidal titers), serum drug concentrations, and other tests to evaluate organ function. 

Although this method was designed for folates in general, differential microbiological testing could give an indication of reduced folate concentration. 

The ingredients of each blend were thoroughly mixed in a large ribbon blender. The entire food preparation and packaging operation was carried out in a sanitary manner. A quantity of each blend was appropriately subpackaged for the various physical, chemical and microbiological tests. 

Microbiological methods classical microbiological tests can be used to detect C. botulinum. 

Organization of the Pharmaceutical Quality Assurance Microbiological Testing Laboratory... 

Establishing, staffing, and running the microbiological testing laboratory,... 

The four major trends in the pharmaceutical microbiological testing laboratory are ... 

PDA Technical ReportNo. 33, The Evaluation, Validation and Implementation of New Microbiological Testing Methods, Bethesda, MD, June 2000. 

Schlatterer and Weise ( ) compared a microbiological inhibition test with TLC for detection of sulfonamides in kidneys and muscles of slaughtered animals. About 30% of kidney samples positive by the microbiological assay were negative by TLC. Conversely, 30% of muscle samples positive by TLC did not give a positive microbiological test. 

Although many B-lactam antibiotics have been described, a relatively small number are used in food-producing animals and these are the only ones of concern as residues. Microbiological test procedures are ordinarily very sensitive to B-lactam antibiotics (49). 

Penicillins form several major metabolites which are excreted in the urine (83,84). These metabolites are usually inactive microbio-logically and they would not be detected by the usual microbiological tests. There are no analytical methods for these metabolites in tissues and, therefore, little is known as to their occurrence and persistence in tissues. There are no methods available for identifying residues of some commonly used B-lactam antibiotics including carbenicillin and ticarcillin. For cephapirin and ampicillin, except for one HPLC method for ampicillin in milk (79) only TLC procedures (72-74,76) with detection by bioautography are reported. 

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