This test is conducted to determine the absence of Burkholderia cepacia complex (Bcc) in non-sterile pharmaceuticals especially those intended for inhalation, oral, oromucosal, cutaneous, or nasal use. The test is conducted to determine if a substance complies with an established quality criterion and should be conducted for raw materials as well as finished products.
The test is conducted by adding the test article to Soybean Casein Digest Broth (SCDB) followed by incubation. The solution is then streaked onto a plate of Burkholderia cepacia selective agar for determination of the presence of the any Bcc organisms. All controls as specified in the USP are included in the analysis. Prior to performing the first analysis of the test solution, a suitability test is conducted to validate there are no interfering factors in the test article that could interfere with the analysis.
This test is conducted to determine total mesophilic bacteria and fungi that will grow under aerobic conditions in non-sterile pharmaceuticals and certain non-sterile medical devices. The test is conducted to determine if a substance complies with an established quality criterion and should routinely be conducted for raw materials as well as finished products.
Aliquots of a test article are tested using a membrane filtration, pour plate or spread plate method. A filter or test aliquot are plated on appropriate agar plates and incubated as directed in the USP. Following incubation, the total aerobic microbial count and total fungi (yeast and mold) count present in the test article is determined. Prior to performing the first analysis of the test solution, a suitability test is conducted to validate there are no interfering factors in the test article that could interfere with the analysis.
This test is conducted to determine the absence of USP specified microorganisms in non-sterile pharmaceuticals and certain non-sterile medical devices. The USP microorganisms of interest are:
Those microorganisms appropriate for the product under test should be selected for analysis. The test is conducted to determine if a substance complies with an established quality criterion and should routinely be conducted for raw materials as well as finished products.
The test is conducted by adding the test article to an enrichment broth and then streaking the enriched sample onto selective agars for determination of the presence of the defined objectionable organisms. All controls as specified in the USP are included in the analysis. Prior to performing the first analysis of the test solution, a suitability test is conducted to validate there are no interfering factors in the test article that could interfere with the analysis.
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