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Certainly, there are many different aspects of product safety and one of the major requirements is that products are free from objectionable microorganisms.
The raw ingredients may be contaminated with them.
Improper cleaning and sanitization of the processing and filling equipment used in the manufacturing 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.
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 <51> “Antimicrobial Effectiveness Testing”, and similarly in other international compendia (European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP), Personal Care Product Council (PCPC) and ISO 11930. An overview of the Preservative Effectiveness testing process is described below.
The basic concept for Antimicrobial Preservative Effectiveness Testing is the same through the various methodologies utilized, and may be summarized as follows:
This is the compendia used primarily for pharmaceutical products. However, many personal care companies also utilize this method for their products as well. It segments the testing into product categories: Injections, Topical Products, Oral Products in aqueous bases, and Antacid products. Most personal care items fit into the Topical Product Category.
Although USP <51> is used by some for cosmetic risk assessment, the Personal Care Products Council (PCPC) Guideline methods serve as the nominal industry standard for cosmetics. Other PCPC methods are available, which evaluate the preservative efficacy of other personal care items such as wipes, anhydrous formulations, etc.
Has three categories: Parenteral/Ophthalmic, Topical and Oral Preparations. This method uses only four microorganisms. The intervals evaluated depend on the category of the product.
Similar to USP <51> but differs in the manner of microbial preparation.
Similar to USP <51>, the ISO 11930 method is written specifically for cosmetic products. It is quickly becoming the “go-to” test method for evaluating the preservative effectiveness of cosmetics and personal care products.
In situations where a client has developed their own method for antimicrobial preservative effectiveness testing, their protocol can be adopted for their specific formulations.
When used wisely, synthetic and natural preservative systems will reduce or kill microorganisms present in a product due to incidental microbial contamination which may occur over the course of normal product use.
Antimicrobial Preservative Efficacy testing is essential for cosmetic, pharmaceutical and personal care product manufacturers to identify which preservative combination(s) and concentration(s) are appropriate for microbial growth prevention while minimizing undesirable preservative side effects. Moreover, preservative formulations must meet regulatory standards for the protection of human health and market approval.
Many more microbiological testing services are also provided, and a full list may be found at www.cptclabs.com.
In addition to Antimicrobial Effectiveness Testing, other CPTSM Departments stand ready to provide testing support in demonstrating the safety of your new or current products.