Independent of the quality audit of the growth medium (i.e., growth promotion testing). A positive control for a media fill is a sealed product container of medium that is inoculated with a small.
Growth promotion testing of culture media appears to be a trivial test, but this perception is deceiving. Almost everyone can agree that with the criticality of microbiological tests, it is extremely important that culture media performs properly. Culture media is used in most assays in a microbiology laboratory, and if the media does not properly support growth, false negative results may be obtained. Likewise, contaminated media may yield false positive results. Opinions on when and how the testing should be performed sometimes vary within the pharmaceutical industry.This article is written with the pharmaceutical industry in mind. However, the concepts may cross over into other industries that utilize microbial culture media.
The article discusses some of the guidance documents and regulatory expectations regarding media growth promotion and provides guidance on establishing a compliant growth promotion test.Overview Of The Growth Promotion AssayMedia can be purchased in a ready-to-use format, prepared from dehydrated media, or prepared from raw materials. Regardless of how the media is prepared, it is essential that it functions properly to ensure the assay requiring the media yields accurate results.
If media does not support growth, false negative results may be obtained, and potentially contaminated products may be released to consumers. Thus, the seemingly simple growth promotion test is a crucial part of any microbiological laboratory. The growth promotion test may also be known as nutritional adequacy testing, fertility testing, media challenge testing, or quality control testing of media.
Customers may purchase environmental monitoring supplies as part of the test service from Nelson Labs for validation and ongoing process monitoring of manufacturing facilities and clean environments. Commercially Prepared Media (Plates)Nelson Labs recommends a variety of air fall-out plates, convex plates for surface and personnel monitoring. It is recommended that manufacturers purchase directly from commercial media suppliers to ensure minimal shipping and handling. Hardy Diagnostics –. Becton Dickinson –. Fisher Scientific (distributor) –. VWR (distributor) –Always request a certificate of analysis (CofA) from commercially prepared media providers.
For confirmation testing on commercially prepared media, Nelson Labs provides growth promotion testing services following USP and EP guidelines. Water Sampling BottlesFor sampling water, we recommend start, mid, and end run sampling for routine process monitoring to assess water over time in a controlled environment or manufacturing process. Most facilities establish initial limits with a water system validation; then through observed data and seasonality monitoring, they are able to scale back their sampling plans for ongoing system monitoring based on trend analysis and risk assessments.
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We offer multiple bottle types depending on the test required: conductivity and TOC bottles, water bottles with and without thiosulfate, as well as endotoxin sampling tubes.It is important to use the appropriate bottle in order to best manage the integrity of the water test sample. For example, the amber bottles used for conductivity and TOC (one bottle for both tests) limit light contact with the sample; polystyrene tubes for endotoxin are endotoxin-free, thus minimizing background contamination from the container; thiosulfate is used to inhibit the action of treated water from common chemicals such as chlorine.
Applicable Standards. PDA TR13.
USP 1116. Current Good Manufacturing Practice (cGMP)Testing Locations. (Gibraltar Laboratories).Study OutlineFor environmental monitoring tests, please see the following:.For growth promotion studies, a standard broad spectrum screen following guidance in EP/USP chapters is used. Standard pricing includes five organisms: Staphylococcus aureus (Gram-positive cocci), Pseudomonas aeruginosa (Gram-negative rod), Bacillus subtilis (spore former), Candida albicans (yeast), and Aspergillus brasiliensis (mold). Testing generally includes two samples per organism plus pH check and negative controls.
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Additional organisms or panels are charged separately.If you have additional questions about Environmental Monitoring Supplies for Air or Water testing, or would like to consult with the experts at Nelson Labs, just or call us at +1 (801) 290-7500.