Limiting the growth of microorganisms in various products helps to prevent them from spoilage and protects users from potential infections. There are a few factors that determine the efficacy of a preservative, this includes the active component of the product, the formulation in which it is incorporated and the container / packaging the product is in. If any of the components change, it is necessary to re-evaluate how the preservatives will continue to perform.
Pharmacopoeial standards require multi-dose pharmaceutical products to contain antimicrobial preservatives in order to protect against microbial growth and will also require preservative efficacy testing to ensure the safety of the product throughout its life cycle. Similarly, regulations on medical devices may also require proof of antimicrobial barrier efficacy, particularly if the marketing of the device makes claims in regards to antimicrobial efficacy.
Antimicrobial Efficacy of Preservatives in Pharmaceutical Products
Preservative efficacy testing is a routine method in our microbiology labs and we offer validation and analysis to assess the efficacy of preservation systems across a wide range of product types including parenteral, ophthalmic, topical or oral.
Efficacy is evaluated by challenging the preparation with a suitable range of microorganisms. Samples are taken at set time intervals and any organisms that remain are enumerated. The preservative properties are adequate if there is no increase or there is a significant reduction.
Our extensive in-house culture collection also enables us to offer efficacy studies following pharmacopoeial requirements, or customised to clients’ individual requirements.