Antimicrobial Preservative Effectiveness Test
Antimicrobial Preservative Effectiveness Testing
Government regulations require that the safety of pharmaceutical, cosmetic/personal care and OTC products be demonstrated prior to their introduction into the marketplace.
Certainly, there are many different aspects of product safety and one of the major requirements is that products are free from objectionable microorganisms.
How do these microorganisms (bacteria, yeast and mold) get into the products? There are a variety of ways:
- The raw ingredients may be contaminated with them.
- Improper cleaning and sanitization of the processing and filling equipment used in the manufacture or the packaging materials, such as bottles/jars, caps and cartons.
- Microorganisms can also be unintentionally introduced into the product over the course of routine use by the consumer.
Because some of these microorganism species pose health risks to humans, synthetic and natural antimicrobial preservatives are often added to such products to inhibit microbial growth and/or kill microorganisms.
Preservatives can pose toxicity risks, however, when added to formulations in excess. Thus, it is imperative that product manufacturers add preservatives in amounts sufficient to impede microbial growth but low enough to avoid toxicity in users.
How do manufacturers determine antimicrobial effectiveness?
Preservative Effectiveness testing can confirm which preservatives (or combinations thereof) and at what concentration(s) are appropriate for preventing microbial growth in a particular product formulation.
Antimicrobial Preservative Effectiveness Testing is well-documented in regulatory compendia such as United States Pharmacopoeia Chapter “Antimicrobial Effectiveness Testing”, and similarly in other international compendia (European Pharmacopeia (EP), and Japanese Pharmacopeia (JP), Personal Care Product Council (PCPC) and ISO 11930. An overview of the Preservative Effectiveness testing process is described below.
