Microbiological test laboratory

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 ... 

ORGANIZATION OF THE PHARMACEUTICAL QUALITY ASSURANCE MICROBIOLOGICAL TESTING LABORATORY... 

There are many methods available to the microbiological test laboratory that determine frmgicidal and fungistatic properties of plastics (a.2-a.4). 

Specifics on the types and rates of microbiological attack. These must be determined by using other methods such as chemical and microbiological analysis of the solution and materials from the corrosion sites. Consideration must be given to limitations of electrochemical techniques for MIC studies, noted previously under Corrosion Testing Laboratory Tests and subsequent subsections. 

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. 

Although some European countries still accept the results of the four plate test as confirming the presence of antibiotic residues in samples ( ), other work indicates that FPT test is not necessarily reliable. The occurrence of natural microbial inhibitors in tissues has frequently been noted (4,9,49,82), It has also been frequently observed that the results obtained by microbial and physicochemical procedures sometimes differ considerably (9,10,45,82,86), Results obtained in our laboratory suggest that even inactivation by penicillinase may not be totally specific for B-lactam antibiotics (W), The specificity of immunoassay procedures depends on the specificity of the antibody used in the test (95), Specific antisera are not widely available at present. Physicochemical procedures are therefore essential for identification and confirmation of suspect residues detected by microbiological tests. 

Therapeutic Goods Administration Laboratories of Australia (TGAL) (1990), Guidelines for Assessing the Results of Microbiological Tests on Nonsterile Pharmaceuticals for Human Use, TGAL, Canberra, Australia. 

Samples for laboratory microbiological testing normally need to be received either early in the workweek (for observation before the end of the week) or on the last work day of the week (for observation on the first day of the following week). Laboratory practices vary, so check first. 

A common practice in microbiological testing is that pharmaceutical ingredients and products are tested without full consideration of their significance. Sometimes, all raw materials purchased and product manufactured are submitted to the microbiology laboratory... 

Presented at the EURACHEM/EQUALM Workshop Proficiency Testing in Analytical Chemistry, Microbiology and Laboratory Medicine , 24-26 September 2000, Boras, Sweden... 

Eurachem (1996) Accreditation for laboratories performing microbiological testing. European cooperation for accreditation of laboratories. EAL-G18. Eurachem... 

The most useful microbiologic test for anthrax is a standard blood culture, which should show growth within 6-24 h. Blood cultures are likely to be positive early in the course of illness. In the October 2001 inhalational anthrax cases, aU patients who had not received antibiotic therapy had blood cultures positive for 5. anthracis. However, blood rapidly becomes sterile after initiation of antibiotic therapy, so the sensitivity of blood cultures declines significantly for patients with prior antibiotic therapy (9). Clinicians should order blood cultures only for patients in situations where they suspect bacteremia and not routinely on all patients with ILI symptoms who have no probable exposure to anthrax. When ordering blood cultures, clinicians must alert the laboratory to the possibility of anthrax, so that the lab performs appropriate biochemical testing and species identification. 

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