Antimicrobial Efficacy Testing (AET)
At Lucideon, we can perform antimicrobial effectiveness testing (AET or PET (Preservative Efficacy Testing)) on an array of products including, but not limited to, oral products, parenterals, health supplements, medical devices, pharmaceuticals, sanitaryware, cleaning products and cosmetics.
Antimicrobial efficacy testing is performed to prove that products with “antimicrobial” or “preservative” claims actually work. Some products may be used to treat infections and thus need to prove they are effective for safety and efficacy reasons; whereas some products and packaging contain preservatives to improve stability and shelf life, and to reduce the risk of contamination through repeated use by the user.
Any product stored within a container that is repeatedly opened, exposed to skin, hands or mucous membrane contact, or delivered in doses through repeated withdrawals, poses a high risk of harbouring bacterial growth, unless effective properties are incorporated into the product and/or the packaging container. For non-sterile products, preservatives are also used to ensure microbial contaminants are not picked up during the manufacturing process.
We can validate the removal/resistance to build up of bacteria, mould, fungi, and other soils on a range of materials, formulations and surfaces. We inoculate your products with a specified and validated concentration of each of your challenge organisms. Over a period of 28 days the product is examined to determine the number of viable microorganisms which survive at each specified time interval and the log-reduction is calculated. We can also check that the preservatives you use are kept within the recommended limits, to ensure there are no risks of toxicity to the user.
We test to industry and regulatory standards for antimicrobial properties, including pharmacopeial standards (e.g. USP<51>), or to your own internally developed methods. We can also develop customized, validated test methods when off-the-shelf solutions won’t do.
AET can be performed to support product claims when comparing the effectiveness of products against antimicrobial build up to competitors’ products, especially for products that are inherently designed to treat infections e.g. wound dressings, implant coatings, etc. Before (or instead of) going into long and expensive clinical trials it is desirable to ensure that, in vitro, the performance is as expected. Testing such as minimum inhibitory concentration (MIC), time kill, and zone of inhibition testing, can also form part of these studies.
Lucideon’s expert scientists have extensive knowledge in microbiology, analytical chemistry and surface science to help design and perform your AET to the highest standards and provide extensive supporting services, should they be required, including understanding why your product is or isn’t displaying the right anti-microbial efficacy to support regulatory submissions, product design, and claim substantiations. We are here to help you optimize your current materials, products and methods or develop new ones. We have our own range of antimicrobial materials and technologies that could help you make a breakthrough with your new product developments, for example.