LexaMed has expanded our testing capabilities to include the following assays:
- Antimicrobial Preservative Effectiveness (USP <51>)
- USP <61> Microbiological Examination of Non-sterile products: Microbial Enumeration Tests
- USP <62> Microbiological Examination of Non-sterile products: Tests for Specific Microorganisms
The Antimicrobial Preservative Effectiveness test is designed to verify the efficacy of a preservative system to reduce bacterial populations and prevent growth of fungi in multiple dose injectables, multiple dose topical and oral materials and other solutions which contain antimicrobial preservatives. This test should be performed on all aqueous-based products such as ophthalmic, optic, nasal, oral and irrigation solutions. This test is conducted in compliance with USP <51>.
In May of 2009, harmonization of USP with the European Pharmacopeia (EP) resulted in two new chapters for the evaluation of non-sterile products, USP <61> and USP <62>. USP <61> describes a total aerobic standard plate count whereas USP <62> is the method for screening of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella species, fungal organisms, and a quantitative MPN for Bile Tolerant Gram Negative bacteria. Conducting both these methods will accomplish similar testing as previously performed by the USP Microbial Limits test. This testing is recommended for all pharmaceutical raw materials, certain non-sterile medical devices and dietary supplements.