We perform antimicrobial effectiveness testing (AET) or preservative effectiveness testing to help evaluate your product’s ability to withstand microbial contamination during use. Our experts provide this testing for injections packaged in multiple-dose containers, as well as for products containing antimicrobial preservatives. We also test products such as aqueous-based, multiple-dose topical and oral dosage forms, and pharmaceutical dosage forms including otic, ophthalmic, irrigation, nasal and dialysis fluids.
This type of test is performed according to USP <51> Antimicrobial Effectiveness Testing, EP 5.1.3 Efficacy of Antimicrobial Preservation and CTFA Preservative Challenge Testing. Testing for the following microorganisms is required per USP <51>: Escherichia coli, Staphylococcus aureus, Candida albicans, Aspergillus brasiliensis and Pseudomonas aeruginosa.
We perform antimicrobial effectiveness testing for method suitability and for routine testing. Our capabilities for bioburden testing include:
- Membrane Filtration Method: A quantitative technique that isolates colonies of bacteria and fungi from a fluid sample using a membrane filter and vacuum
- Standard Plate Count/Pour Plate Method: Isolates bacteria and fungi by plating a sample preparation to a petri dish and adding nutrient agar that allows growth of any microorganisms present
- Spread Plate Method: Isolates bacteria and fungi by plating a sample preparation to a nutrient agar plate
- GMP-compliant stability chambers for storing your products, which we monitor for temperature and humidity
Contact our analytical testing team at Whitehouse Labs by clicking below