Through the continuing enhancement of our internal systems and sample receipt processes, the testing for USP <51> has seen a significant reduction of time in receiving these test results.
Antimicrobial Effectiveness testing is performed to determine the efficacy of preservatives within a compound against specific challenge organisms. DYNALABS’ AE testing procedure is based of USP chapter 51 guidelines. This test is used for testing multi-dose pharmaceuticals and products.
Testing for USP<51> requires Suitability Testing and will also require the preservative to be declared on the samples labeling. Required sample amount(s) for the the routine testing will be based upon the preservative indicated.
Products are divided into four groups, indicated on Table 1 of this PDF link. Also, specific product and testing information can also be found by downloading the PDF or please contact our consulting staff at 314-241-3962 by email at email@example.com.
When preservatives are used for the purpose of minimizing growth of microorganisms, the effectiveness of the preservative within the context of the compound’s formulation will need to be validated. There are standard organisms used for this test. Testing to show the preservative is effective should include out to and including the beyond use date. In addition to the standard organisms, it is always good practice (but not required) to test the effectiveness of the preservative against organisms isolated from the facility in which the product is compounded.
DYNALABS method for antimicrobial effectiveness testing is based on the standards delineated in USP <51>. DYNALABS will perform this test using customer supplied product. The standard organisms called out for in USP <51> will be supplied by DYNALABS. DYNALABS can work with the customer to help determine if testing of resident organisms found within the compounding facility is feasible and beneficial to them.
FORMS TYPICALLY TESTED
- All forms of medications with preservatives
- Multi-dose medications