Antimicrobial Products – Testing and Performance

Penicillium fungi growing on a silicone gasket would be prevented if an antimicrobial additive were included in the product formulation.

Antimicrobial product testing and performance represent a design feature in a finished product.  Generally speaking, antimicrobial performance is related to a product’s ability to resist or deter the growth of microorganisms on or in the product.  The only legitimate demonstration of antimicrobial performance a test demonstrates is the removal or resistance of the test product to microorganism this is tested against.

Antimicrobial product testing involves several general concepts that are important to understanding how antimicrobial’s are used in different materials,  and how they are tested for antimicrobial performance once the material has been created.

[efaccordion id=”faqs”]

[efitems title=”Antimicrobial Products – Key Concepts” text=”An antimicrobial product is a product that uses an approved additive (such as a chemical) to provide a material with resistance to microorganisms.

1. The Term ‘Treated Product’ is derived from the EPA guidance on a very select type of  antimicrobial product, which is managed by the EPA TREATED ARTICLE EXEMPTION
2. The Treated Article Exemption, is used as guidance by manufacturers and formulators to make product performance claims relating to antimicrobial treated products that are generally intended for consumer use.
3. Because of the nature these claims, and the regulations involved with the EPA Treated Article Exemption, the claims made about a product MUST be demonstrated by antimicrobial testing.
4. A ‘treated product’ is one that has the antimicrobial added to it to create this antimicrobial attribute.  e.g. a product is ‘treated’ and then demonstrates antimicrobial performance by testing.
5. ALL chemicals used for the purpose of antimicrobial performance must be purposed and approved by a Regulatory agency such as the EPA.
6. Finally, claims related to the performance and benefit of the treated product, are VERY strictly regulated and must comply with the EPA guidance for antimicrobial products and materials.

Once the product and its intended use is determined, the design, formulation and manufacturing can occur.”]

[efitems title=”Antimicrobial Product Design” text=”

1. Antimicrobial product features need to be evaluated based on the intended use or intended claims for that product.
2. Antifungal, antibacterial, and antialgal product performance are each distinct and may require different additives or antimicrobial formulations.
3. Antimicrobial product intended use affects the level of testing and durability needed from a given product.
4. Durability can require optimization of both the formulation and the antimicrobial additive.”]

[efitems title=”Antimicrobial Product Formulation” text=”

1. Antimicrobial product formulation is focused on the antimicrobial additives (ex. triclosan, see link below); which is known as the Active Ingredient.
2. Antimicrobial additives must be compatible with the formulation, or be incorporated in a manner that allows them to be ‘bound’ to the finished product.
3. Antimicrobial plastics, textiles, or liquids etc. will each have a different considerations regarding these characteristics, product performance and finished product cost.”]

[efitems title=”Antimicrobial Product Manufacturing” text=”

1. Antimicrobial additives can be costly as assessed by the percent of a formulations finished cost.
2. Determining the correct application, concentrations and other formulation factors  are vital to saving time and money.
3. Manufacturing and handling of the finished product can have dramatic effects on the finished product antimicrobial performance, knowing these limitations in advance can avoid costly reformation or time consuming trouble shooting of these issues.”]

[efitems title=”Antimicrobial Product Testing and Quality Control” text=”

1. Antimicrobial testing is used to determine the efficacy of antimicrobial additives or inherent antimicrobial properties of a given material or product.
2. Quality Control Testing provides the an important assessment of a  product’s microbiological performance for consistency over time.
3. Once established, quality control testing is used to manage costs and product performance related to changes in production, formulation modification, or raw material sourcing by different suppliers or manufactures.”]

[/efaccordion]

For more information about Antimicrobial Testing, contact us at 847-483-9950 or info@situtest.com.

References:

EPA TREATED ARTICLE EXEMPTION

Triclosan

Guidance on formulation modification