CREM Co Labs offers full-service hand sanitizer efficacy testing for manufacturers, covering all required studies to register hand hygiene products in the United States and Canada. We ensure your hand sanitizers – whether leave-on handrubs or rinse-off handwashes – meet the rigorous efficacy requirements set by the U.S. FDA and Health Canada. All testing is performed under strict Good Laboratory Practice (GLP) conditions, and any studies involving human volunteers follow Good Clinical Practice (GCP) guidelines for ethical and reliable results. Our comprehensive antimicrobial effectiveness testing provides you with the data and documentation needed for successful regulatory submissions.
Types of Products Covered
We test all types of hand antiseptic products (also known as human-use antiseptic drugs) used in healthcare or consumer settings. This includes:
- Handrubs (Leave-On Sanitizers): Alcohol-based hand sanitizers, gels, sprays, or foams that are applied and left on the hands without rinsing. These leave-on products are often used by consumers on-the-go and by healthcare personnel between patients. We verify their fast-acting broad-spectrum kill on skin, as required for OTC antiseptic rubs.
- Handwashes (Rinse-Off Antiseptic Soaps): Antibacterial hand soaps, surgical scrubs, and other handwash products that are applied with water and rinsed off. These include antiseptic washes for healthcare personnel and pre-surgical hand scrubs. We assess their ability to reduce bacteria on the skin during washing, ensuring they meet healthcare handwash standards.
- Human-Use Antiseptic Drugs (Professional & Consumer Use): This umbrella category includes both the consumer and professional-use products above. In regulatory terms, hand sanitizers and antimicrobial soaps are considered antiseptic drug products for human use, whether sold to the public or used in hospitals. CREM Co Labs tests personal use hand sanitizers (e.g. consumer hand gels) as well as professional use antiseptics (e.g. hospital hand rubs and surgical hand antiseptics) to support their specific claims and uses.
By covering leave-on and rinse-off formulations alike, we provide complete handrub testing and handwash testing services. Whether your product is an everyday consumer sanitizer or a clinical antiseptic scrub, we have the protocols to evaluate its performance.
Regulatory Guidance and Efficacy Requirements (FDA & Health Canada)
Hand sanitizer manufacturers must demonstrate that their products are safe and effective according to the guidelines of the U.S. Food and Drug Administration (FDA) and Health Canada. CREM Co Labs stays up-to-date with these regulations to ensure our testing meets all current requirements:
- FDA – Healthcare & Consumer Antiseptic Guidelines: The FDA has issued rules for both healthcare antiseptics and consumer antiseptic rubs. In the United States, antiseptic hand rubs and washes are regulated as OTC (over-the-counter) drug products. Recent FDA rulings – such as the 2017 final rule for Health Care Antiseptic Productsand the 2019 final rule for Consumer Antiseptic Rubs – outline the need for robust efficacy data. Manufacturers must provide data from in vitro laboratory studies and in vivo clinical simulation studies to prove that a hand sanitizer rapidly and significantly reduces microorganisms on skin. For example, FDA guidance historically recommended testing hand sanitizers against a broad panel of microbes (23 bacterial strains and 1 fungal species) to demonstrate broad-spectrum antimicrobial effectiveness. Products are expected to achieve specific log reductions of bacteria on hands in controlled studies (such as clinical simulation trials) to be considered effective. We ensure that all FDA-required efficacy endpoints – from immediate germ reduction to, in the case of professional products, persistent activity – are thoroughly evaluated. (For detailed reference, see FDA’s final rules on Healthcare Antiseptics (2017) and Consumer Antiseptic Rubs (2019).
- Health Canada – Human-Use Antiseptic Drug Guidance: In Canada, hand sanitizers and antimicrobial hand cleansers are regulated as drug products requiring a Drug Identification Number (DIN). Health Canada’s guidance document on Human-Use Antiseptic Drugs provides the efficacy testing criteria for both personal (domestic) use and professional (hospital/commercial) use antiseptics. This guidance (July 2019) specifies that any product making claims of killing specific organisms, having a persistent effect, providing a certain log reduction, and/or antiviral action must be supported by appropriate data. In practice, Health Canada expects in vitro tests (to screen antimicrobial activity) and in vivo tests on human skin to demonstrate product performance. For instance, a professional healthcare hand rub in Canada might need to pass a standardized hand rub efficacy test (such as ASTM or EN methods) to be authorized. If a product is not effective against a certain category of microbes (e.g. fungi), the product’s labeling must disclose that limitation. We design our test programs to align with Health Canada’s requirements, ensuring you have the evidence needed for DIN applications under this guidance. (See Health Canada’s official guidance on Human-Use Antiseptic Drugs for more details.)
By adhering to these regulatory frameworks, CREM Co Labs helps you navigate the complex rules. Our experts will summarize FDA and Health Canada efficacy requirements in plain language and ensure that your product’s testing plan ticks all the boxes for compliance. We keep detailed records and follow GLP standards so that our data is accepted by regulatory agencies in support of your product registration.
Comprehensive Test Methods (In Vitro and In Vivo)
To fully establish the antimicrobial effectiveness of hand sanitizers, we employ a battery of both laboratory (in vitro) and human in vivo test methods. This two-pronged approach provides thorough evidence of efficacy:
- In Vitro Test Methods: These are controlled laboratory tests performed in test tubes, petri dishes, or suspension assays to measure how well the product kills microbes in a controlled environment. Key in vitro methods we conduct include:
- Time-Kill Assays: Suspension tests that mix the hand sanitizer with microbes for specified contact times (e.g. 15, 30, 60 seconds) to determine the logarithmic reduction in viable organisms. For example, ASTM E2315 is a standard quantitative time-kill procedure that we use to evaluate how quickly and completely a formulation kills bacteria in vitro. We also utilize appropriate ASTM and EN suspension standards (such as EN 13727 for bacteria, EN 1362 for fungi, EN 14348 for mycobacteria, EN 14476 for viruses) to measure virucidal and bactericidal activity in solution.
- Minimum Inhibitory Concentration (MIC): A classic microbiological assay to find the lowest concentration of your product (or active ingredient) that inhibits visible growth of a microorganism. This helps characterize the potency of the hand sanitizer’s active ingredients against various bacteria and fungi. MIC testing is useful for comparing effectiveness across strains and ensuring the formula meets any pharmacopoeial criteria for antimicrobial activity.
- USP <51> Antimicrobial Effectiveness Test: If your hand sanitizer formulation contains preservatives or is a multi-use product, we can perform the USP <51> test (also known as the Preservative Efficacy Test). In this assay, the product is intentionally inoculated with a panel of standard organisms (including bacteria, yeast Candida albicans, and mold Aspergillus brasiliensis) and the microbial counts are measured over 28 days. This verifies that the product itself resists microbial contamination over its shelf-life. USP <51> is often required for topical drug products to ensure they remain safe during use.
- ASTM and EN Standard Suspension Tests: Depending on regulatory needs, we also run standards like ASTM E1052/E1053 (for virucidal activity in vitro) or EN 13727 (bactericidal suspension test) and others to support specific claims. These in vitro protocols allow us to screen efficacy against a broad range of pathogens under precise conditions before moving to live-subject trials.
- In Vivo Test Methods (Clinical Simulations): These tests involve human volunteers and are designed to simulate real-world use of hand sanitizers, measuring actual reduction of microbes on skin. Our lab conducts in vivo studies under GCP conditions with appropriate ethical approvals. Key in vivo methods include:
- ASTM E2276 (Hygienic Handwash/Handrub – Fingerpad Method): In this test, a group of adult volunteers’ fingertips are contaminated with a standard bacterial suspension (such as Serratia marcescens or E. coli). A specified volume of the test product is applied to the finger pads for a short contact time (usually 10–30 seconds), then the surviving bacteria are recovered and counted. The ASTM E2276 method measures the immediate reduction of transient bacteria on skin from a handrub or handwash product, simulating a single-use scenario. It is a stringent test that ensures the product can achieve a significant log reduction in microbes in a very short time, as is expected in practice. Similar tests are performed on fungi and viruses using ASTM E 2613 and ASTM E1838
- ASTM E2755 (Bacteria-Eliminating Handrub Method): This is a newer in vivo method specifically developed for alcohol-based hand rubs (leave-on sanitizers). It evaluates the bacteria-eliminating effectiveness on the entire hands of adult volunteers. Volunteers contaminate their hands with a test bacteria (often Serratia marcescens, a standard marker organism) and then apply the hand sanitizer as directed (e.g. rub hands together for 30 seconds until dry). Instead of rinsing, neutralizing solutions are used to recover bacteria from the hands post-treatment. We then count the bacteria to determine the log reduction achieved by the handrub. ASTM E2755 is designed to mimic real usage of hand sanitizers in healthcare settings and is aligned with FDA’s efficacy expectations for healthcare personnel hand rubs.
- EN 1500 (European Hygienic Handrub Test): For products destined for international markets or to meet Health Canada’s recognition of international standards, we perform EN 1500. This is a European standard Phase 2/Step 2 test where volunteers’ hands are contaminated with a reference bacteria (E. coli), and the test handrub must reduce the bacteria on hands at least as effectively as a reference 60% propanol solution. EN 1500 is a rigorous comparison against a proven benchmark, ensuring the hand sanitizer’s efficacy is on par with hospital-grade alcohol rubs.
- EN 12791 (Surgical Hand Antisepsis Test): If you are making a surgical scrub or handrub claim (products used by surgeons prior to surgery), we can conduct EN 12791. In this in vivo test, volunteers perform a surgical hand scrub or rub with the product, and microbial counts are taken immediately after use and again 3 hours later. The product must produce a high log reduction of resident skin bacteria and maintain a significant reduction for 3 hours under gloves. This demonstrates both immediate and persistent antimicrobial activity required for surgical hand antiseptics. EN 12791 is often needed to support claims of prolonged or persistent effect in a healthcare setting.
- ASTM E1174 (Health Care Personnel Handwash) and Other In Vivo Protocols: For antimicrobial handwash soaps, we employ methods like ASTM E1174, which simulate healthcare personnel washing their hands multiple times and measure the cumulative reduction in bacteria after repeated uses. Similarly, we can adapt to other standardized protocols (ASTM or FDA Tentative Final Monograph methods) that involve multiple sequential hand contaminations and washes to evaluate both immediate and residual effects. Our experts will choose the appropriate in vivo method based on your product type and claim (for example, a persistent effect claim might require a specific test design to demonstrate continued activity over time).
All test methods are performed with validated neutralization techniques and controls to ensure accurate results. We include appropriate positive controls (using known effective reference antiseptics) and negative controls (such as plain soap or water) to benchmark performance. By using these internationally recognized test methods, CREM Co Labs generates reliable data that regulators accept as evidence of antimicrobial efficacy.
Broad Pathogen Coverage in Testing
Hand sanitizers are expected to work against a wide spectrum of germs. Our efficacy testing covers all major classes of pathogens, so you can support broad-spectrum claims and specific kill claims as needed. We maintain a large library of microbial strains and can test against organisms from each category:
- Bacteria: We test against both Gram-positive and Gram-negative bacterial species that are common hand contaminants or infection culprits. For example, Staphylococcus aureus (Gram-positive) and Escherichia coli (Gram-negative) are routinely used as representative test organisms. We also challenge products with harder-to-kill bacteria like Pseudomonas aeruginosa or Klebsiella pneumoniae when broad-spectrum or hospital efficacy is needed. Our panel can include up to dozens of bacterial strains (the FDA monograph recommends 23 strains) to ensure robust evidence that your sanitizer kills a broad range of bacteria.
- Mycobacteria: To support tuberculocidal claims or to show efficacy against tougher cell types, we test against nontuberculous mycobacteria such as Mycobacterium terrae. Mycobacteria have waxy cell walls and are more resistant to disinfectants, so demonstrating kill of M. terrae proves the product’s strength. Mycobacterium terrae (ATCC 15755) is the standard surrogate for the tuberculosis bacterium in efficacy tests. If your product is intended for healthcare settings or high-level disinfection, including this organism in testing can be important.
- Fungi (Yeasts & Molds): We evaluate fungicidal activity by testing against common fungal pathogens. Candida albicans (a yeast that can cause skin and healthcare-associated infections) is a typical test organism, and Aspergillus brasiliensis (formerly A. niger, a black mold) is used to represent filamentous fungi. These fungi are used in standards like USP <51> and others to ensure a product can control yeast and mold. If you want to claim your hand sanitizer is effective against fungi (for example, for use in environments where yeast infections are a concern), we will include appropriate fungal assays in the test plan.
- Viruses: CREM Co Labs has the capability to test hand sanitizers against viruses – including both enveloped viruses (which are generally easier to kill) and non-enveloped viruses (which are more resistant). We use safe surrogate viruses where applicable to represent pathogens of interest. For example, we can test against Influenza A virus or Coronavirus (such as SARS-CoV-2) to demonstrate efficacy against enveloped viruses. For non-enveloped viruses like norovirus, which cannot be easily grown in lab conditions, we use accepted surrogates such as murine norovirus or feline calicivirus to validate antiviral performance. We also test against tough non-enveloped viruses like Adenovirus and Poliovirus according to standards (e.g., EN 14476 requires testing against Adenovirus and Poliovirus for a full “virucidal” claim). If your product claims to kill specific viruses (e.g. “kills 99.9% of cold & flu viruses”), we will include those viruses or appropriate surrogates in the efficacy testing to substantiate the claim.
In addition to the above, we can accommodate testing for other relevant microbes on request – for instance, bacterial spores (like Clostridioides difficile spores) or emerging pathogens – if needed for specialized claims. Our pathogen coverage is comprehensive, giving you confidence that your hand sanitizer has been challenged against the microbes of greatest concern. The result is data that supports broad-spectrum labeling such as “kills 99.99% of germs” as well as data for specific organism kill claims.
Types of Claims We Support
With our wide range of tests, CREM Co Labs can generate evidence for virtually any antimicrobial claim you want to make on your hand sanitizer’s label. Common claims we support include:
- Broad-Spectrum Antimicrobial Claims: Demonstrations that the product is effective against a broad range of bacteria (and other microbes). For example, claims like “kills 99.9% of germs” or “broad-spectrum antibacterial action” require testing against multiple organism types. We design a test program covering Gram-positives, Gram-negatives, and more to justify these claims. By testing against the standard panel of organisms (per FDA/Health Canada guidance), we ensure you have data to back a broad-spectrum statement.
- Fast-Acting / Instant Kill Claims: If you wish to claim that your sanitizer works within a short time (such as “Kills germs in 15 seconds”), we perform time-kill studies at that contact time and in vivo hand rub tests to confirm rapid efficacy. Our methods can demonstrate significant log reductions even with brief exposure, supporting claims of a fast-acting product.
- Persistent Effect Claims (Residual Activity): For products marketed to healthcare or for long-lasting protection, we can evaluate persistence, meaning the product continues to reduce bacteria on the skin for an extended period after application. Tests like surgical hand antisepsis (EN 12791) or sequential wash tests can show a residual effect over 3-6 hours or after multiple uses. This data supports claims such as “provides up to 6 hours of protection” or “persistent antimicrobial activity.” Health Canada and FDA require specific in vivo study designs to validate persistence claims, and we have the expertise to conduct those studies correctly.
- Surgical Scrub Claims (Healthcare Personnel Use): If your product is intended as a surgical hand scrub or a healthcare personnel handwash/rub, it must meet higher efficacy thresholds. We conduct the required tests (e.g., ASTM E1115 or EN 12791 for surgical, ASTM E1174 for healthcare personnel handwash) to show that the product achieves the necessary log reductions immediately and, if applicable, after multiple applications. This supports claims like “meets FDA surgical scrub requirements” or “effective for surgical hand antisepsis.” Our data will demonstrate compliance with the stringent criteria for hospital-use products.
- Virus-Specific Claims: Many hand sanitizer brands want to highlight effectiveness against particular viruses (especially in light of recent pandemics). We can provide data to claim “kills coronavirus (SARS-CoV-2)”, “effective against influenza and cold viruses,” or “kills norovirus*” (*with appropriate surrogate testing). By including viral efficacy tests (EN 14476 or ASTM methods) in your project, we generate the log reduction values needed to make virus kill claims.
- Fungus-Specific Claims: For products aimed at markets concerned with fungal infections (for instance, in clinical or athletic settings), we test and support claims like “kills yeast and mold.” If your sanitizer is proven to kill Candida albicans or other relevant fungi, you can confidently make antifungal claims. We ensure that any such claim is backed by solid in vitro data (e.g., a >99.9% kill in a suspension test) and/or in vivo evidence as required.
All claims are tied to scientifically valid data from our laboratory. We will advise you on the test requirements for each type of claim so you choose appropriate wording that regulators will accept. Whether it’s a general antimicrobial claim or a specific pathogen claim, CREM Co Labs has you covered with the necessary testing.
Regulatory Support and Submission-Ready Reports
Beyond just testing, CREM Co Labs supports you through the regulatory submission process. We provide complete, well-documented reports suitable for inclusion in your product registration dossiers:
- FDA Submissions (NDA/ANDA or OTC Monograph): For the U.S. market, we ensure all studies are conducted under FDA’s GLP regulations (21 CFR Part 58). Our final reports include all the data, methods, and quality control information needed for a New Drug Application (NDA) or Abbreviated NDA, if required. If your product still falls under an OTC monograph pathway, our data will be formatted to address the relevant monograph standards or FDA guidance. We can also provide summary reports highlighting how your product meets FDA efficacy criteria. This scientific evidence is critical for convincing FDA reviewers of your hand sanitizer’s effectiveness.
- Health Canada DIN Applications: We prepare study reports to satisfy Health Canada’s requirements for a DIN application for antiseptic products. Our team is familiar with the Common Technical Document (CTD) format and can populate the efficacy sections with our study results. We make sure to clearly tie each test to the claims and use-pattern of your product, as expected by Health Canada’s evaluators. The data we generate will demonstrate conformity to Health Canada’s guidance (e.g. showing both in vitro and in vivo efficacy, with any necessary organism-specific results). This facilitates a smoother review process for your product license.
- GLP and GCP Compliance: All our efficacy studies come with a GLP compliance statement and raw data appendices, giving regulators confidence in the integrity of the data. For any in vivo studies with human subjects (such as hand rub tests), we follow GCP and obtain ethics approvals, and we include copies of Institutional Review Board (IRB) approvals and informed consent forms in the report. We take care of volunteer recruitment and ensure the study is conducted safely and according to protocol. This level of compliance and documentation means your submission will meet the expectations of regulatory agencies on both sides of the border.
- Expert Consultation and Customized Protocols: Our regulatory support team can help interpret any agency feedback or requirements. If FDA or Health Canada requests additional data or a novel test, we can develop custom protocols leveraging our expertise in disinfectant and antiseptic testing. In fact, CREM Co Labs has been a leader in developing novel antimicrobial test methods and has contributed to standards organizations. We use this expertise to your advantage, ensuring you get the best possible claims for your product while satisfying regulatory standards. Before we initiate any full GLP study, we often conduct a pre-assessment screening (non-GLP) to gauge your product’s performance; this helps save time and money by identifying any issues early. We then proceed to formal testing with confidence in meeting label claim requirements.
All data and reports we produce are ready for submission – you won’t need to spend time reformatting or justifying methods. Our reports clearly reference the standard test protocols used (ASTM, EN, USP, etc.) and include all necessary controls and statistical analysis of results. This makes it straightforward for regulators to review and accept your data. CREM Co Labs effectively becomes your partner in the regulatory approval process, from planning the right tests to delivering a strong scientific package that supports your product claims.
Contact Us – Partner with CREM Co Labs for Efficacy Testing
Getting your hand sanitizer’s efficacy validated is a crucial step to enter the market and earn consumer trust. Partner with CREM Co Labs to leverage our scientific expertise and regulatory experience. We are committed to helping hand sanitizer manufacturers succeed by providing end-to-end regulatory hand sanitizer testing services.
Ready to ensure your hand sanitizer meets FDA and Health Canada requirements? Contact CREM Co Labs today to discuss your testing needs or to get a quote for our services. Our team will guide you through the process, tailor a test program for your specific product, and deliver reliable, GLP-compliant data to support your claims. With CREM Co Labs as your efficacy testing partner, you can confidently move forward in registering and marketing your hand sanitizer – backed by solid science and in full compliance with North American regulations.