ALG is an industry leader in the specialty contract lab space and comprises FDA- and EPA-focused laboratories across the United States, with facilities in San Francisco, Minneapolis, and Boston. Our ALG team is focused on Helping Protect Life™ through infection prevention, with the most comprehensive testing solutions in the antimicrobial, pharmaceutical, medical device, biotech, and healthcare spaces.
ALG offers comprehensive microbiology testing for the Antimicrobial, Medical Device, and Pharmaceutical industries. Take a look at a partial listing of our test offerings. If you are unable to find the specific test you are looking for, please Contact Us. *Microbiology Testing* - EN 13624 Chemical Disinfectants and Antiseptics: Quantitative Suspension Test for Fungicidal Activity for Instruments Used in the Medical Area - EN 14347 Chemical Disinfectants and Antiseptics: Quantitative Test for Basic Sporicidal Activity - EN 14348 Chemical Disinfectants and Antiseptics: Quantitative Test for Basic Mycobactericidal Activity - Evaluation of Algicides and Algistats Intended for Use in Swimming Pools or Industrial Water Cooling Systems using Pure Culture Technique - Ex-Vivo Skin Model Testing of Antimicrobial Lotions or Sanitizers - Food Contact Sanitizer Testing for Towelettes (Modification of AOAC Method 960.09) - JIS Z 2801 / ISO 22196 Japanese Industrial Standard Test for Determining Antimicrobial Activity - Mildew Fungistatic Test for Fabrics or Hard Surfaces - Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC) Tests - OECD Quantitative Disk Carrier Test Method (Modification of ASTM Method E2197) - Re-Use Stress Testing and Evaluation of Disinfectants - Reusable Medical Device Disinfection Validations - Test Method for the Continuous Reduction of Organisms on Treated Surfaces - Test Method for Determining the Efficacy of Antimicrobial Surfaces as Sanitizers - Test Method for Determining the Residual Self-Sanitizing Activity of Treated Surfaces - USP 51 Preservative Effectiveness Testing Method (and CTFA Method M-3) - AATCC 147 Assessment of Antimicrobial Finishes on Textile Materials: Parallel Streak Method - AATCC 30 Test III Assessment of Mildew and Rot Resistance of Textile Materials - AOAC Method 955.16 Available Chlorine in Disinfectants - AOAC Method 955.17 Fungicidal Activity Method - AOAC Method 960.09 Germicidal and Detergent Sanitizing Action of Disinfectants - AOAC Method 961.02 Germicidal Spray Method - AOAC Method 965.12 Tuberculocidal Activity of Disinfectants - AOAC Method 965.13 Disinfectant (Water) for Swimming Pools - AOAC Method 966.04 (Modification) Sporicidal Method to Determine Efficacy of Products Used in Aseptic Filling Applications - AOAC Method 966.04 Sporicidal Activity of Disinfectants - ASTM E1153 Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces - ASTM E2149 Standard Test Method for Determining the Antimicrobial Activity of Immobilized Antimicrobial Agents - ASTM E2180 Standard Test Method for Determining Antimicrobial Activity in Polymeric or Hydrophobic Materials - ASTM E2197 Standard Quantitative Disk Carrier Test Method - ASTM E2274 and E2406 Standard Test Method for the Evaluation of Laundry Disinfectants - ASTM E2274 and E2406 Standard Test Method for the Evaluation of Laundry Sanitizers - ASTM E2315 Time Kill Assay for Antimicrobial Agents - ASTM E2362 / AOAC Method 961.02 (Modification) Pre-Saturated Towelettes for Hard Surface Disinfection Test Method - ASTM E2871 and E2562 Standard Test Method for Evaluating Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm - Disinfection Qualifications for Cleanroom Disinfectants - Efficacy of a Disinfectant or Sterilant Applied to a Room Via a Fogger or Misting Device - EPA Quantitative Tuberculocidal Suspension Method - EPA Residual Self-Sanitizing Activity of Dried Chemical Residues on Hard Nonporous Surfaces - EN 1040 Basic Bactericidal Activity of Chemical Disinfectants - EN 1275 Quantitative Suspension Test for the Evaluation of Basic Fungicidal or Basic Yeasticidal Activity of Chemical Disinfectants - EN 1276 Quantitative Suspension Test of Bactericidal Activity of Chemical Disinfectants - EN 13697 Quantitative Surface Test for the Evaluation of Bactericidal or Fungicidal Activity - EN 1650 Quantitative Suspension Test for the Evaluation of Fungicidal Activity of Chemical Disinfectants - AATCC 100 Assessment of Antibacterial Finishes on Textile Materials - AATCC 100 Residual Self-Sanitizing Activity of Laundry Additives *Liquid Anitmicrobial Efficacy Tests* - Re-Use Stress Testing and Evaluation of Disinfectants - EN 13727 Chemical Disinfectants and Antiseptics: Quantitative Suspension Test for Bactericidal Activity for Instruments Used in the Medical Area - AOAC Use Dilution Test for Liquid Disinfectants (Methods 964.02, 955.14 and 955.15)
ALG offers our clients full product chemistry analysis including chemical characterization of active ingredients, testing of product-specific impurities, physical chemistry analysis and storage stability testing. Our product chemistry testing capabilities include a broad range of antimicrobial active ingredients (AIs) or preservatives. Additionally, many customers find value in our seamless coordination of product chemistry testing and antimicrobial efficacy testing needs; both required to support regulatory registrations. Whether your antimicrobial product is based upon quaternary ammonium compounds, chlorine, hypochlorite, hydrogen peroxide, or peracid chemistries, Accuratus Lab Services can measure your AI. This allows us to correlate your AI concentrations to microbiological or viral efficacy results – which is especially important for reusable or unstable formulations. In compliance with GLP regulatory standards, Accuratus Labs offers development of custom enforcement methods for product submission, analytical method validation, and method transfer validations of previously validated enforcement methods from your site. *Product Chemistry Testing includes:* - Chemical Characterization - Accelerated Storage Stability - Long-term Storage Stability - Physical Chemistry - pH - Color - Odor - Density (Specific Gravity) - Viscosity - Physical State - Flash Point Accuratus Lab Services offers the product chemistry studies required by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) Assessment Guidelines 830 series to characterize your antimicrobial product and to define any potential hazards associated with its routine handling and use. Chemistry studies for supporting product registrations are performed under our rigorous GLP program. In addition to chemical characterization and physical chemistry tests, Accuratus Labs is positioned to detect chemical residuals to support your cleaning validation needs. Common chemical residuals that ATS Labs can detect include: - Residual Carbohydrate - Residual Protein - Residual Hemoglobin
The virology lab at Accuratus Labs offers clients comprehensive virology testing services and unparalleled expertise in the area of virucidal efficacy testing. Our lab capabilities, along with 25 years of method development and regulatory experience, make us the contract laboratory of choice for testing your antiviral products.
The dedicated group of virologists at Accuratus Labs have decades of pioneering experience in technical and regulatory aspects of virology. We provide the most comprehensive virucidal testing services to the developers, manufacturers, and users of antiviral products. The virology lab maintains numerous cell lines and an extensive collection of human, mammalian, and avian viruses. We are constantly expanding our viral library to provide clients with the most current and surrogate viruses to meet all testing needs and currently have the capability to test BSL-2 and BSL-3 organisms as specified by the Center for Disease Control and Prevention (CDC).
For the developers of disinfectant and sterilant products, Accuratus Labs has the virology expertise to guide you from developing an economical screening plan for determining your product’s range of virucidal activity through the completion of your GLP studies for EPA or FDA submission. For the developers of medical and clinical products, Accuratus Labs provides customized testing services designed for your specific applications. Our capabilities range from in-vitro virucidal assays to ex-vivo assays on a model skin surface, enabling us to support development of topical products, wound care treatments, and unique antiviral materials. We also have virucidal capabilities to expedite your preclinical evaluations of antiviral products.
A controlled manufacturing cleanroom environment requires a sound disinfectant qualification program. Disinfectants utilized within these environments must be validated to confirm their effectiveness for use. Proper rotation of the disinfectants can be determined based on the data collected in this study.
Why should I choose Accuratus to perform my disinfectant qualification study?
How do I know which method to follow for my disinfectant testing study?
Tube Dilution Method
Coupon Testing Using the Swab Recovery Method
Accuratus can create a proposal for your disinfectant qualification study with the following information:
Contact Us with any questions. We are happy to take you through the disinfectant testing process.
For more than 30 years, ALG has been a leader in medical device testing services. The company’s renowned problem-solving approach provides numerous advantages, including - Reduced cost - Low or no risk - Rapid regulatory approvals - Faster time to market - Greater customer control of testing - Minimal lab excursions, out-of-spec tests, and schedule disruptions Also, our expanding pharmaceutical division provides efficient synergies for clients with medical devices containing pharmaceuticals. For example, these combination products include drug-coated stents. Our medical device testing facilities are U.S. FDA-regulated to meet all GLP standards (21 CFR Part 58). Our medical device testing labs are staffed by highly educated, trained, experienced people. Result: an unmatched combination of knowledge and technology. Accuratus Labs helps medical device manufacturers provide safe, high-quality products. And we do it fast, with maximum cost-effectiveness.
Liquid Antimicrobial Efficacy
Antimicrobial liquid pesticide products take the form of liquid concentrates, ready-to-use liquids/sprays and pre-saturated towelettes. Concentrate and ready-to-use liquids can also be used in conjunction with custom application devices, such as fogging, misting or vaporization equipment.
Accuratus Lab Services offers standard and custom efficacy testing to support the claims for all types of antimicrobial liquid products.
What are Antimicrobial Liquids?
Antimicrobial sprays and liquids destroy or suppress the growth of bacteria, viruses, or fungi on objects and surfaces and include:
Antimicrobial liquids are registered with the U.S. Environmental Protection Agency (EPA) and include everything from medical-grade sterilants to carpet sanitizers.
Treated Article Efficacy
An antimicrobial treated article is an article treated with, or containing, an antimicrobial pesticide that is intended to protect or preserve the article itself. A paint containing an antimicrobial active to protect or preserve the paint coating or a fabric impregnated with silver to prevent deterioration of the material are examples of treated articles. The United States Environmental Protection Agency (EPA) does not require registration of treated articles if the active substance is registered for use in or on the article and the sole purpose is to protect the article, not the person using the product. The EPA requires certain labeling of these articles to ensure that they do not mislead the public with false claims and efficacy data must be generated to support these non-public health claims.
Materials treated with an antimicrobial must be registered as a pesticide if the article is intended to protect public health. For example, articles that claim to kill specific bacteria, viruses, or fungi are considered public health claims. Efficacy data must be generated and submitted to the EPA for registration.
Accuratus Lab Services has years of experience performing antimicrobial efficacy testing of treated articles to support both public health and non-public health claims. We can help determine the antimicrobial performance of a variety of materials such as hard surfaces (plastics and alloys), porous materials (textiles and fabric), and coatings. Learn more about the antimicrobial treated article tests Accuratus Lab Services offers to support public or non-public health claims.
Fogging and Misting Efficacy
Gas and vapor technologies are being used with fogging or misting devices to disinfect, sanitize or sterilize enclosed areas. Many of these systems are remarkably effective at decontaminating all the hard, non-porous surfaces within an enclosed room. The United States Environmental Protection Agency (EPA) sent a letter on April 1, 2013, notifying those antimicrobial product registrants with current registered antimicrobial pesticides that efficacy data must be provided to the EPA to support fogging or misting claims. Any new registrations must also submit efficacy data for claims using fogging or misting to disinfect, sanitize or sterilize rooms.
Accuratus Lab Services worked closely with EPA officials through a Pesticide Registration Improvement Act (PRIA) submission review in developing these protocols that have now been approved by the EPA. Having the protocols formally approved provides manufacturers with a faster and more economical solution to satisfying the new regulatory requirements. These EPA-approved protocols can be used to support the use of any type of fogging and misting device that registrants would like to include on their product label. Accuratus Lab Services has extensive experience working with antimicrobial pesticide fogging or misting products and has developed protocols for supporting efficacy label claims for bacterial disinfection, virucidal efficacy, efficacy against Clostridium difficile spores, tuberculocidal efficacy, non-food contact sanitization, and food contact sanitization.
Accuratus Lab Services has a dedicated fogging and misting testing room at Accuratus Lab Services is equipped with independent air handling and temperature control to perform this testing. Additional test rooms are available to meet manufacturers’ specific space requirements based on the device used in testing. This enclosed testing space can be configured to meet your product’s specific testing needs against a variety of bacteria, fungi, viruses or bacterial spores. We can help you develop a custom protocol, screen the product and complete the final GLP testing.
Pesticide Device Efficacy
Antimicrobial Pesticide Devices that work by physical means are regulated by the United States Environmental Protection Agency (EPA) but do not require registration. However, pesticide regulations do require that device producers generate efficacy data to support all claims. Ultraviolet lights are a good example of antimicrobial pesticide devices as the antimicrobial is generated and used on site.
Accuratus Lab Services has extensive experience performing efficacy testing of devices. We have a dedicated, customized room for testing the efficacy of devices used in rooms or other enclosed spaces. We can help you develop a custom testing protocol, complete efficacy screening tests and generate the necessary compliant efficacy data to support your claims.
Hand Sanitizer Efficacy
In-vitro testing is required by the U.S. Food and Drug Administration (FDA) to substantiate the effectiveness of all hand sanitizing products. The Agency’s extensive testing requirements, summarized in the Tentative Final Monograph, can present challenges to product producers and manufacturers. The Agency requires testing to be performed on over 20 organisms including Gram negative bacteria, Gram positive bacteria and yeast organisms. The FDA also states that “…there must be no claims, either direct or by implication, that a product has any activity against an organism which it has not been tested.” As such, it is recommended that clinically-relevant pathogens be included in your testing regimen.
Accuratus Lab Services can help navigate the testing requirements for hand sanitizers and develop a streamlined testing regimen to quickly move your product from the development to the final testing stage. We provide services for hand sanitizer formulations that follow the ASTM E2315 Time Kill Assay for Antimicrobial Agents method, viral suspension assay (ASTM E1052), AOAC 955.16 Available Chlorine assay and Minimum Inhibitory Concentration (MIC) Test and Minimum Bactericidal Concentration (MBC) Tests. Refer to our microbial library for an extensive list of organisms and antibiotic resistant pathogens available for testing.
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