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Recent EPA Guidance: Test Methods for Adding Disinfectant Efficacy Claims to Products for Use on Soft Surface Textiles

The EPA recently published guidance on test methods for adding disinfectant efficacy claims to products to be used on soft surface textiles in non-residential settings.  This includes liquid formulations and spray products that satisfy all efficacy requirements for hospital or healthcare disinfectant claims on hard, non-porous surfaces.  This additional claim is only applicable for non-clothing fabrics, textiles, and textiles/upholstery that are representative of clinical and/or institutional environments.  This claim is not intended to address efficacy against mycobacterium, fungi, yeasts, or bacterial spores, nor residual (extended) efficacy claims.

The recommended test methodology provides log10 reduction as the quantitative measure of efficacy on a soft surface textile.  Three representative soft surface textiles are specified in the method: vinyl seating fabric, privacy curtain fabric, and non-PVC fabric.  To receive a bactericidal efficacy claim, a product should achieve the performance standard on all three material types with each base bacterium (S. aureus and P. aeruginosa).

The recommended method uses discs of 1 cm in diameter or squares of each fabric textile as carriers.  The carriers are to be contaminated with the test strain in the presence of a three-part soil load, dried, and then exposed to the disinfectant.  For purposes of efficacy testing, all products must be liquid when applied to the carriers .  After the specified exposure time, the treated carriers are to be neutralized, diluted, and plated.

It is required that three lots of product be evaluated, each lot on a separate test date.  Five carriers of each textile type per each bacterium are to be evaluated against the product, and three untreated control carriers are to be included.  The target mean control carrier count level is 4.0 – 5.5 log10 CFU/carrier, and each carrier should be within this range.  Each lot of the product should achieve a minimum mean 4.0 log10 reduction in ≤ 10 minutes when compared to the controls to support disinfectant claims for soft surface textiles for each of the three representative surface textiles.

The EPA’s recent release of comprehensive guidance on test methods for disinfectant efficacy claims on soft surface textiles in non-residential settings highlights the direction the antimicrobial product market is headed. This latest guidance represents the continuation of a broader trend within the EPA towards providing more specific and tailored recommendations for antimicrobial products. For manufacturers and businesses operating in the antimicrobial product market, this guidance presents both challenges and opportunities. Complying with these stringent testing protocols may demand additional resources and investment, but it also paves the way for differentiation and quality assurance. Products that meet the EPA’s criteria will have a competitive edge, instilling greater confidence among consumers, healthcare facilities, and institutional buyers.

 

 

 

 

Terri Eastman

Terri Eastman

Antimicrobials Expert

Terri Eastman is a highly accomplished microbiologist who received her degree from Montana State University. With eight years of experience at Skyland Scientific Services, a leading company in pharmaceutical validation consulting, Ms. Eastman has extensive expertise in microbiology and has supervised the in-house microbiology laboratory while conducting numerous on-site performance qualifications at pharmaceutical manufacturing facilities....