Hard Surface Disinfectant Efficacy Testing

CREM Co Labs provides efficacy testing for hard surface disinfectants, crucial for public health. Regulatory agencies like the EPA in the US and Health Canada have guidelines to ensure these products meet performance standards. CREM Co Labs is capable of performing all of these tests under Good Laboratory Practices (GLP).

Standard Methods & Compliance

• Internationally accepted test protocols (such as AOAC Use-Dilution, AOAC 961.02 Germicidal Spray, and relevant ASTM methods such as ASTM E1053 and ASTM E2197) ensure rigorous evaluation of hard-surface disinfectant efficacy.

• GLP-compliant studies produce reliable data accepted by the U.S. EPA, Health Canada, and other regulators, streamlining your product’s path to approval.

• An experienced team and state-of-the-art facilities provide expert guidance from test design to final report, delivering clear, actionable results for regulatory submissions.

Broad Pathogen Coverage

• Comprehensive testing against diverse microorganisms – from Gram-positive & Gram-negative bacteria (Staphylococcus aureus, Salmonella enterica, Pseudomonas aeruginosa) to enveloped & non-enveloped viruses, fungi, and mycobacteria – fully validates your disinfectant’s effectiveness.

• Supports all major disinfectant claims (bactericidal, virucidal, fungicidal, tuberculocidal) for hospital-grade and commercial products, providing a one-stop solution to confirm your label claims meet stringent regulatory standards.

Soft-Surface Disinfectant Efficacy Testing Services

Comprehensive Testing Capabilities

CREM Co Labs offers specialized efficacy testing for disinfectants intended for soft surfaces (textiles, fabrics, upholstery). We employ rigorous, industry-standard test methods to ensure your product effectively eliminates pathogens on porous materials. Our capabilities include:

• Advanced Test Methods: We utilize EPA-recommended soft-surface carrier tests and a modified AOAC 961.02 Germicidal Spray method tailored for fabrics​. For viral efficacy, we conduct ASTM E1053 surface virucidal tests, and for laundry-use disinfectants we use ASTM E2274 and ASTM E2406 to simulate in-wash disinfection conditions​. These validated protocols provide reliable data to substantiate soft-surface disinfection claims.
• Broad Microbial Spectrum: Our lab challenges soft-surface disinfectants against the key microorganisms required by regulators, including Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella aerogenes, and relevant viruses​. Testing with these Gram-positive and Gram-negative bacteria and viral pathogens ensures your product meets broad-spectrum efficacy expectations for soft surfaces.
• All Product Types: We assess both direct-application products (such as fabric sprays and mists for upholstery or carpets) and laundry-use disinfectants (detergent additives for pre-soak or in-wash disinfection). Our facility simulates real-world use for each category – from spray application on textiles to laundering protocols – so whether your disinfectant is applied via spray or used in a washing cycle, we generate accurate performance data to support its intended use.

Regulatory Compliance & Expert Support

Working with CREM Co Labs means partnering with a team that understands the regulatory landscape for antimicrobial products in both the United States and Canada. We help disinfectant manufacturers navigate requirements and confidently prepare for product registrations:

• EPA & Health Canada Compliance: All testing is aligned with U.S. EPA and Health Canada guidelines for soft-surface disinfectants​. We produce Good Laboratory Practice (GLP) compliant data designed for submission to regulators, ensuring your results meet the stringent efficacy criteria of EPA’s Office of Pesticide Programs and Health Canada’s disinfection standards. Our reports provide the necessary evidence for label claims on soft-surface use, streamlining your path to market approval​.
• Accredited Quality and Expertise: CREM Co Labs is an OECD-GLP accredited laboratory, meaning our study data is recognized and accepted by regulatory agencies worldwide​. Our scientists bring extensive experience in antimicrobial efficacy testing and have even contributed to developing standard test protocols​. This expertise and credibility ensure that your soft-surface disinfectant is tested with the highest level of quality and scientific rigor.
• Focused Client Support: We prioritize a clear, efficient testing process – from initial consultation through final report. Our team advises on optimal test plans to achieve the best possible claims for your disinfectant, helping you maximize your product’s value. By entrusting your soft-surface efficacy testing to CREM Co Labs, you gain a reliable partner committed to delivering accurate results, regulatory-ready documentation, and the confidence that your product’s performance is backed by solid science and compliance.

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Advanced Aerobiology (Bioaerosols) Testing 

CREM Co Labs (CCL) has extensive experience in and experimental facilities for studying the role of indoor air as a vehicle for human pathogenic vegetative bacteria, spore-forming bacteria, viruses, fungi and mycobacteria. It has also introduced several innovative test protocols to study microbial survival in indoor air and has assessed physical and chemical means of indoor air decontamination (Ijaz et al 2016; Kashkooli et al. 2019; Sattar et al. 2016; Zargar et al. 2016; 2019; Zargar et al. 2021). Further, it has developed a quantitative method to study simultaneous reductions in environmental surface contamination from air decontamination in the same setting (Zargar et al., 2019). CCL’s novel method for direct capture of bacteriophages such as MS2 and phi6 was published in 2021 (Zargar et al. 2021), the paper describes a novel method for assessing air decontamination technologies against airborne bacteriophages as surrogates of enveloped and non-enveloped viruses.

In 2021, CCL’s aerobiology protocols became part of ASTM International’s standards (ASTM E3273-21). CCL’s scientists were also part of the working group of Association of Home Appliance Manufactures for writing AC-5: Method for Assessing the Reduction Rate of Key Bioaerosols by Portable Air Cleaners Using an Aerobiology Test Chamber and soon after CREM Co labs became an AHAM certified lab.

CCL’s aerobiology expertise was reviewed and approved in 2022 by the U.S. Environmental Protection Agency (EPA), and in October 2022, the first air sanitizer was  registered with EPA using data generated at CCL.

CCL has two room-sized chambers (~900 cu. ft. and ~1000 cu. ft.), designed to conform to the 2012 guideline from the EPA, to assess microbial survival and inactivation in indoor air. CCL’s unique facilities and robust test protocols for studying microbial fate in air and assessing technologies claiming air decontamination comply with the guideline of the EPA.

Hand Sanitizer Efficacy Testing

Overview: CREM Co Labs provides comprehensive efficacy testing for hand sanitizers, including both leave-on hand rubs and rinse-off hand washes (such as surgical scrubs). We use a combination of rigorous in vitro laboratory assays and in vivo clinical simulation studies to evaluate how effectively your product kills germs and meets industry standards. Our expert team ensures that your formulation’s label claims are backed by solid, scientifically valid data – giving you confidence in your product’s performance and compliance with regulatory requirements.

Key Test Methods: We employ a range of standardized test protocols to thoroughly assess hand sanitizer effectiveness:

• In Vitro Assays: ASTM E2315 (quantitative time-kill assay), EN 13727 (European suspension test for bactericidal activity), USP <51> (antimicrobial effectiveness test), and more. These GLP-compliant lab tests measure the product’s broad-spectrum killing power in controlled conditions.
• In Vivo Studies: ASTM E2755 (healthcare personnel hand rub efficacy using adult volunteers)​, ASTM E1174 (healthcare hand wash method), EN 1500 (European hygienic hand rub standard), and EN 12791 (European surgical hand disinfectant standard). These GCP-compliant clinical tests simulate real-world use on human skin, demonstrating how well the sanitizer reduces transient and resident microbes on hands.

Microorganisms Tested: Our efficacy evaluations challenge products against a broad spectrum of microorganisms to ensure broad‐spectrum claims. Test organisms include common Gram-positive and Gram-negative bacteria (e.g. Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa), fungi (e.g. Candida albicans, Aspergillus brasiliensis), and viral pathogens or surrogates (such as Influenza A virus and norovirus surrogates). This comprehensive panel covers the key pathogens of concern in healthcare and consumer settings, confirming that your hand sanitizer is effective against germs that matter.

Regulatory Compliance Support: All testing at CREM Co Labs is conducted under strict Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) standards, ensuring high-quality data and integrity​. Our detailed reports provide the necessary evidence to support your product’s regulatory submissions – including compliance with the U.S. FDA’s OTC Hand Sanitizer monograph requirements and Health Canada’s requirements for issuing a Drug Identification Number (DIN). By partnering with CREM Co Labs, hand sanitizer manufacturers can confidently advance their products to market with proven efficacy, trusted data for regulators, and credible claims for consumers.

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Antiseptic Skin Preparation Testing

Overview: CREM Co Labs offers specialized testing for preoperative, pre-injection, and pre-catheterization antiseptic skin preparation products. These are the critical antiseptics applied on patients’ skin before surgeries or procedures to prevent infection. We evaluate how rapidly and persistently your product reduces skin bacteria at the application site, ensuring it meets the stringent standards needed to protect patient safety. Our team’s expertise in both GLP-compliant lab studies and GCP-compliant clinical trials means we can thoroughly assess your skin prep’s performance under realistic conditions.

Standardized Test Methods: We utilize recognized efficacy protocols such as ASTM E1173 (Standard Test Method for Evaluation of Preoperative/Preinjection Skin Preparations) to measure reductions in skin flora on human subjects​. In these studies, volunteers’ skin (typically on areas like the forearm, abdomen, or groin) is treated with the antiseptic, and microbial counts are taken before and after application. This allows us to determine how significantly the product decreases the natural resident skin bacteria (including Staphylococcus aureus and other common flora) and how it performs against any specific pathogens of interest (with fungal tests included if applicable for your claims).

Efficacy at Critical Time Points: Our testing examines antiseptic performance at multiple time intervals to ensure both immediate and long-lasting action. Key observation points include 30 seconds (immediate kill), 10 minutes (short-term effect), and 6 hours post-application (residual activity)​. We verify that your product achieves the required log reductions in bacterial count – for example, at least a 3 log₁₀ reduction on high-bacteria, moist skin sites and ≥2 log₁₀ on drier skin sites​– in line with FDA guidelines for healthcare antiseptics. Demonstrating a ≥99.9% kill (3 log) on moist areas and ≥99% kill (2 log) on dry areas is crucial for regulatory acceptance and clinical efficacy, and our studies ensure your product meets or exceeds these benchmarks.

Regulatory Alignment: All antiseptic skin prep testing at CREM Co Labs is designed to support regulatory compliance. We adhere to both FDA and Health Canada requirements – including the FDA’s Final Rule on Health Care Antiseptic Products and Health Canada’s Guidance Document: Human-Use Antiseptic Drugs. Our GLP/GCP compliant studies yield trustworthy data that can be directly used in submissions to regulators. By leveraging our rigorous testing services, manufacturers can confidently demonstrate that their preoperative skin prep products fulfill the latest efficacy standards, helping to secure approvals and instill confidence in end-users through proven, science-backed performance.

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Price List

To order any test or combination of tests, please download the order Test Request Form and Shipping Form below, complete them, and submit them to us. We will then contact you promptly to finalize the necessary  arrangements.