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The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on pharmaceutical products and medical products for quality control purposes. Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden ...
The dip slide test consists of a sterile culture medium on a plastic carrier that is dipped into the liquid to be sampled. [3] The culture is then incubated, allowing for microbial growth. [ 2 ] Most Dip slides consist of 1 - 2 agars attached to a flexible plastic paddle, this allows full contact of the agar onto the desired area for testing. [ 4 ]
Penicillium species, Aspergillus niger and Candida albicans are used in the pharmaceutical industry for microbial limit testing, bioburden assessment, method validation, antimicrobial challenge tests, and quality control testing. [11] When used in this capacity, Penicillium and A. niger are compendial mold indicator organisms. [11]
The amount of light produced is directly proportional to the amount of biological energy present in the sample. [citation needed] Second generation ATP tests are specifically designed for water, wastewater and industrial applications where, for the most part, samples contain a variety of components that can interfere with the ATP assay.
The catalase test tests whether a microbe produces the enzyme catalase, which catalyzes the breakdown of hydrogen peroxide. Smearing a colony sample onto a glass slide and adding a solution of hydrogen peroxide (3% H 2 O 2) will indicate whether the enzyme is present or not. Bubbling is a positive test while nothing happening is a negative result.
Establish critical limits for each critical control point A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce that hazard to an acceptable level. Establish critical control point monitoring requirements
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The test templates that are included in this software define all of the parameters for a particular test method. This program calculates the most efficient way of setting up the desired test on the Model 500 Analyser. A test tutor is also included with Microsoft Omni that gives listed instructions on how to set up and run the test of interest. [18]
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