A-A-51039A
Suspension shall meet the requirements for the test for absence of the organisms listed below under the USP Microbial Limits Tests:
Escherichia coli
Salmonella
Staphylococcus aureus
Pseudomonas aeruginosa
Pseudomonas fluorescens
Suspension shall be tested for the effectiveness of its preservative using the following Preservative Effectiveness Stability Test below or a similar suitable accurate and reproducible method approved by the Food and Drug Administration. The samples shall pass the Preservative Effectiveness Stability Test if the initial inoculums count (NLT3 organisms per ml of product after initial inoculation with an organism) does not increase by more than 50% by the third week and remains at or below that level by the fourth week.
Preservative Effectiveness Stability Test.
Preparation of Inoculum. Validate spectrophotometer used in this assay. Prior to the test, inoculate the specified number of Trytic Soy Agar (TSA) slants (for the Staph Aureus and Enterobacter Cloacae) and Sabourand Dextrose Agar (SAB) slants (for Aspergillus niger) and incubate as follows:
|
Organism |
No. of Slants |
Incubation Conditions |
|
Staph aureus ATCC 6538 |
3 |
30-35oC, 18-24 hours |
|
Enterobacter cloacae ATCC 23355 |
3 |
30-35oC, 18-24 hours |
|
Aspergillus niger ATCC 16404 |
6 |
20-25OC, 7 days |
Procedure:
Sample Preparation.
Prepare a set of four sterile sample containers (tubes or bottles). Label three of the tubes with product lot number and organism. Label one container as a control and fill each container with 20 ml of the suspension.
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