Information

EPA Lower Certified Limit Testing Requirement

The United States Environmental Protection Agency (EPA) recently updated guidelines for antimicrobial efficacy testing. Formerly, EPA required the main tests for disinfection to be performed on several batches of product, with at least one batch aged for a minimum of 60 days.  The new guidelines do not change the...

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3 Pitfalls to Avoid as a New Cosmetic Company

Starting a cosmetic company can be very exciting. Whether it's starting from a home kitchen, working with a private label manufacturer, or even starting a brand-name manufacturing company, there's the thrill of something new and daring. However, there is always risk involved. Much of the risk lies in the...

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Frequently Asked Genetic Sequencing Questions

What is microbial DNA Sequencing? Microbial DNA sequencing is the process of naming a species by identifying its genetic makeup down to the nucleotides. By knowing a fungal or bacterial sample's gene sequence, our lab can compare that DNA to a database of over 20,000 validated species called MicroSEQ ID. This allows us to...

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Traditional Microbial Identification Methods vs. Genetic Sequencing

Environmental sampling and microbial surveillance are key factors in maintaining clean environments and ensuring product sterility. Escaping microbes is nearly impossible, but knowing the identity of an organism helps recognize when and how to take the proper preventative measures. Whether you are interested in product manufacturing, research & development, or knowing points of...

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Phylogeny’s Role in Microbial ID

The Science Behind Phylogeny: Phylogeny is the method of understanding evolutionary relationships by comparing genetic information of organisms. Often, a phylogenetic tree is used to help pinpoint species of similar descent, where each branch resembles a change in physical or genetic variance. By comparing a multitude of known genetic species, our lab identifies organisms with MicroSEQ ID:...

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Ways Microbial Identification Benefits Your Company

The Growing Concern: The widespread necessity for genetic sequencing is growing exponentially as microbial concerns rise among consumers and manufacturing companies. Not only does the presence of unwanted organisms prevent product development, but it can also lead to harmful illness and infection. With microbes being a large and valid concern for...

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The Science of Microbial Identification

In the world of microbial identification, the gold standard method is comparative gene sequence analysis of ribosomal DNA (rDNA) – specifically, the 16S ribosomal RNA gene for bacteria or the LSU D2 region for fungi. The comparative gene sequence analysis of ribosomal DNA (rDNA) has been shown to have...

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Spring Regulatory Sciences

  Spring Regulatory Sciences uses decades of experience to provide clients with efficient, practical, and cost-effective regulatory support for antimicrobial products. It provides complete company representation before the United States Environmental Protection Agency and all state governments. The company is located in Spring, TX a northern suburb of Houston. Spring Regulatory Sciences offers...

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FDA Requirements for Cleaning and Disinfection Validation Studies for Medical Devices

On March 17, 2015, FDA published new guidance describing testing and labeling requirements for reusable medical devices.  The updated guidance is timely, since recent outbreaks of CRE from endoscopes exposed several missing validation studies from implicated manufacturers. FDA's historical guidance pertaining to cleaning and disinfection of reusable medical devices was contained in...

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Variability in Antimicrobial Testing

Introduction Scientific fields such as physics and math are considered to be exact sciences. Biology, including microbiology, is different. Microbiological systems possess a greater number of uncontrollable variables which results in increased experimental complexity and decreased experimental accuracy.  The great number of variables at play in a given microbiological study...

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CTFA M-6 Method Summary

Standard preservative challenge test methods used for determining the preservative effectiveness of water-based products are not suitable for certain product formulations such as wax or oil based products, powders, lip balms, etc. For these types of products it is important to use methods that do not change the physical...

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CTFA M-5 Method Summary

It is important in preservative challenge testing to consider the typical use of the finished product and to test them in their finished state. For example, nonwoven substrates such as presaturated wipes or towelettes, should be tested in the wipe form and not on just the add-on solution. The...

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CTFA M-4 Method Summary

Preservative challenge testing for eye area cosmetics is extremely important to ensure the safety of your consumers. The eyes are a common area for infection by microorganisms such as Pseudomonas species that can be found in cosmetics that are not properly preserved. CTFA M-4 is a guideline for preservative...

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CTFA M-3 Method Summary

Once it has been determined that products are free from harmful microorganisms, it is important to ensure that they remain free from contamination during manufacturing consumer use. That is accomplished through challenge testing the formula with known microorganisms to verify that if the products become contaminated, the preservative system...

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CTFA M-2 Method Summary

The next step in determining the safety of cosmetic and personal care products is to determine if any microorganisms that may be present are "objectionable" microorganisms that may be harmful to the consumer. If any microorganisms are found to be present in the product after testing using the CTFA M-1 method...

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PCPC M-1 Method Summary

It is every cosmetic manufacturers' responsibility to ensure the microbiological safety of their products. The first step in microbiological safety testing is to verify that each cosmetic product is free from contamination that could affect the quality of the product or consumer health. The CTFA M-1 method (much like the USP...

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Lupine Medical

  Offering more than 12 years of medical device experience, Lupine Medical knows all the ins and outs of testing medical devices and the path to getting them on the market. Lupine can assist with every step of the way, starting with medical device design and ending with FDA approval....

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Scientific & Regulatory Consultants, Inc

Scientific & Regulatory Consultants, Inc. (SRC) was started in 1996 by Sally Hayes and Rhonda Jones. SRC offers over 90 years of combined service to the pesticide and antimicrobial industry. Their staff draws from a broad range of expertise including research, development, manufacturing, quality, and registration experience in the antimicrobial...

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Keller and Heckman, LLP

Keller and Heckman, founded in 1962, has a broad practice in the areas of regulatory law, litigation, and business transactions, serving both domestic and international clients from offices in Washington, DC, Brussels, San Francisco, and Shanghai. The firm is a pioneer in the use of interdisciplinary approaches to problem-solving. It...

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Toxcel

toXcel is a medium-sized consulting firm with offices in Gainesville, Virginia and affiliate locations in the United Kingdom and Canada. It provides a wide range of scientific, technical, and regulatory consulting services including federal, state, and regional registrations in North America, Europe, and other international markets. One of toXcel's...

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Delta Analytical Corporation

Delta Analytical Corporation is an antimicrobial and pesticide regulatory consulting firm located near EPA headquarters in the Washington, D.C. Metro area. The firm is most experienced with regard to federal and state registration of antimicrobial agents and pesticides, but well equipped to assist clients with other regulatory questions and...

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Technology Sciences Group, Inc (TSG)

Technology Sciences Group Inc. (TSG) provides state, federal and international expertise on a wide range of scientific and regulatory issues. With offices throughout North America and Europe, TSG assists companies in over 30 countries worldwide, including China, Japan and Australia. TSG works with chemical, pesticide, consumer product, food, personal care...

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MS2 Bacteriophage – A Viral Screening Tool

Introduction to MS2 Bacteriophage Many people are familiar with viruses that infect mammalian cells (e.g. Influenza, Poliovirus, or Rhinovirus), but there are also viruses capable of infecting bacterial cells. These viruses are called bacteriophages. Bacteriophages are easy to work with in the context of disinfectant testing and can provide valuable...

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Biological Aerosol Testing

Introduction Microchem Laboratory is one of just a few labs in the US to provide custom aerobiological testing services for antimicrobial devices and chemicals. Our laboratory has the capacity to perform testing with UV devices designed to decontaminate an entire room or with devices as small as a tabletop microbial sampler. We...

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Floor and Carpet Cleaners

Introduction Home floor care started way back in the early 19th century. With the advent of lavish home furnishings and the beginnings of carpeted and tiled floor, the need for cleaning devices grew rapidly. The Industrial Revolution sparked a great increase in technology and new machinery. As expected, the first...

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Whole Room Disinfection Devices

Introduction Disinfection of whole rooms is becoming increasingly vital in a multitude of industries. Customers and regulatory agencies are vigilantly tracking the habits of food production, livestock care, and healthcare facilities ability to limit hospital acquired infections. Whether the application is used to limit the spread of infection in a...

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Apply for a Job with Microchem Laboratory

To apply for a position, please email Contact*@*Microchemlab.com (remove the asterisks).  State the title of the position for which you are applying, describe your strongest professional attribute in one word, and attach your resume.  If interested, a representative from the lab will contact you.  Please do not call or...

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Toxicity/Safety Definitions

Dermal Irritation - reversible skin damage that occurs as a result of applying a particular substance to the skin and appears shortly after application of the substance. Ocular Irritation - reversible changes to the anterior surface of the eye following the application of a product or ingredient and appears shortly after application. Dermal...

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USP <51> Product Categories

Note: Most cosmetics and personal care products are considered to be category 2 products. Category 1 Injections, other parenterals including emulsions, otic products, sterile nasal products, and ophthalmic products made with aqueous bases or vehicles. Category 2 Topically used products made with aqueous bases or vehicles, nonsterile nasal products, and emulsions, including those...

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Natural and Synthetic Preservatives Used in Personal Care Products

Preservation of cosmetic products is important to ensuring their safety and shelf stability. Luckily, formulators of cosmetics have a number of time-tested preservatives to choose from. The list of preservatives below are commonly used in cosmetic products. In addition to natural and chemical preservatives, pH adjustment can be used to keep...

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Natural vs. Synthetic Preservatives

Customers often ask Cosmetic Test Labs questions about the choice between natural and synthetic preservatives. Choosing whether to use natural or synthetic preservatives for cosmetics is an important decision that has many implications. It will affect product stability, odor , appearance, texture and most importantly, safety. To help customers choose...

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USP <51> Passing Criteria

For Category 1 Products Bacteria: No less than 1.0 log reduction for the initial calculated count at 7 days, not less than 3.0 log reduction at 14 days, and no increase from the 14 days' count at 28 days. Yeast and Molds: No increase from the initial calculated count at 7,...

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ISO 11930 Acceptance Criteria

For each micro-organism, the log reduction is compared to criteria A or B (see below). a) If all the reduction values comply with criteria A below, the formulation satisfies requirement of the preservation efficacy test and, in accordance meets the requirements of this International Standard. b) If all the reduction values...

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Five Elements of a Good Cosmetic Company Website

Cosmetic Test Labs regularly uses the web to identify cosmetic companies that could benefit from the services we provide, such as preservative challenge testing, micro testing, and stability testing. We have navigated through numerous websites and noted a few key distinctions between the well-constructed cosmetic websites and the ones that may benefit...

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Cosmetic Contamination Cases

Why You Should Always Test Your Products Before Marketing When considering cosmetic safety testing, such as routine bacteria and fungal counts and preservative challenge testing, many cosmetic manufacturers and formulators wonder why it is necessary to test their products if they are putting well known preservatives in them and testing...

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Frequently Asked Questions and Helpful Links

1. Are cosmetics currently regulated in the US?  The Food and Drug Administration (FDA) is a government agency put in place to enforce the laws regarding cosmetics, such as the Federal Food Drug and Cosmetics Act (FFDCA). Under the FFDCA, cosmetics manufacturers are responsible for verifying the safety of their...

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10 Qualities to Look for in a Cosmetic Testing Lab

We, at Cosmetic Test Labs, encourage our clients to question every part of the testing process and to shop through other labs to find the one most suitable to their company's individual needs. Many cosmetic companies have no knowledge of the testing process or the role of a testing...

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Five Most Common Types of Preservatives Used in Cosmetics

Cosmetic and beauty products are made up of ingredients that are biodegradable, and this means that microbes can easily break them down. This causes a product to become unpleasant and unsafe for consumers with an added antimicrobial. Preservatives are antimicrobial ingredients added to product formulations to maintain the microbiological safety of...

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New EU Cosmetic Regulation Requirements

As of July 11, 2013, the previous Cosmetics Directive has been replaced with the new European Union (EU) Cosmetic Regulation 1223/2009. The new regulation's intent is to ensure that the health of consumers' is protected and that EU agencies are well informed of the composition, labeling, and safety of...

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Antimicrobial Fabrics and Textiles

For more information, please read the article below, written by Dr. Tanner and originally published in AATCC Review, covering antimicrobial textiles as well as some implications. It is posted here with written permission from the publisher. Click the preview below to read the antimicrobial fabrics article (.pdf) Thanks for exploring Antimicrobial...

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Introduction to Preservatives and “Challenge Testing”

Preservatives are antimicrobial agents that can be found in nearly all consumer products, including foods. Since Microchem Laboratory specializes in the testing of consumer and medical antimicrobials, food preservatives will not be discussed at length (though fundamentally, they serve a similar purpose). Without preservatives, many of the consumer products we...

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Incorporated Antimicrobials or “Treated Articles”

A "Treated article" is industry-speak for a solid or semi-solid object or product rendered antimicrobial by incorporation of an active ingredient into or onto the object itself. For the purposes of this article, "treated articles" do not include medical devices or surfaces with claims to control microorganisms of public health...

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Introduction to Hand Sanitizers

Introduction Liquid hand sanitizers - mostly alcohol-based gels - have enjoyed an explosion in popularity in the last 10 years. If you have traveled by airplane or set foot in a classroom in the US lately, chances are you have seen hand sanitizers in use. Hand sanitizers do not serve as...

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EPA Treated Article Exemption

If Microchem Laboratory had a bacterial colony for each time one of our scientists explained the EPA treated article exemption to a customer, we'd have a loaded petri dish! Microbiology humor aside, our customers know we are glad to help them navigate the complicated world of antimicrobial regulations. If you...

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What is the Difference between GLP and GMP Laboratory Testing Regulations?

People are often confused by differences between Good Laboratory Practice (GLP) regulations and Good Manufacturing Practice (GMP) regulations as they relate to laboratory testing. This is understandable, since both GLPs and GMPs cover lab testing but are very different. In addition, scientists and quality control/quality assurance personnel participating in GLP and...

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How Lab-Tested Materials Keep Buildings Safe from Mold

Mold can form when tiny free-floating reproductive particles, called spores, come in contact with water and virtually any organic material. Spores that dwell for 24-48 hours under these simple conditions can become entrenched, then grow quickly into macrostructures that are visible to the naked eye. Visible mold is often...

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Disinfectant and Sanitizer Testing Requirements

The summary information below was assembled by Antimicrobial Test Laboratories in early 2014. It is believed to be more current (as of publication) than EPA's own 810 series of guidance documents. Product testing requirements change over time, so please check with EPA or a good consultant to verify the accuracy of these...

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Introduction to Antimicrobial Devices

Got microbes? If you want to inactivate them and they reside on an environmental surface, here are the three main options: Disinfectants and sanitizers - most commonly used to destroy microorganisms on environmental surfaces, but some may suffer from various drawbacks. More information about disinfectants and sanitizers here. Antimicrobial surfaces or...

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What is the Difference Between Gram Positive and Gram Negative Bacteria?

The two illustrations that follow represent cross-sections of the cell wall and cell membrane of gram positive bacteria and gram negative bacteria, respectively. Gram Positive Bacterium Gram Negative Bacterium These diagrams are for educational purposes only, and may not be used elsewhere without written permission from Microchem Laboratory. Viewers of this page may...

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What are Bacterial Endospores?

Bacteria propagate when times are good. When times are bad, certain bacteria have the capability to shrink down and encrust critical cellular elements in a tough casing. This is called an endospore.***The process works like this: The, bacterium senses environmental stress, which triggers activation of genes which create a...

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Learn the Basics of Microbiology!

Gaining a basic understanding of microorganisms is the first step to understanding the purpose and function of antimicrobial agents, including disinfectants, sanitizers, and antimicrobial devices. To that end, Microchem Laboratory has assembled some free, educational materials anybody can read and learn from. In other words, here's some science love. This material...

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List of Antimicrobial Regulatory Consultants

Microchem Laboratory is knowledgeable with regard to United States antimicrobial regulations and registration requirements. Company microbiologists gladly share information with customers about EPA and FDA regulations, helping them to select the right test methods and guide their projects to successful completion. Sometimes, however, companies that make antimicrobial devices and chemicals...

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Introduction to GLP Regulations

GLP regulations are frequently misunderstood. The goal of this page is to provide a framework for understanding the "basics" of GLP regulations. Appropriate Facility Separation between work areas, test systems, and other such things are stipulated by the GLPs. The purpose of the facility rules is to ensure that interference between...

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Scientific Notation and Significant Digits in Microbiology

The following is the formula for scientific notation: A x 10B Where A is any number reduced to its significant digits, and B is any integer. Note: This notation is also sometimes expressed as AE(±)B, as often is the case with calculators (e.g., 1E+9). To exemplify the use of scientific notation, take the...

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Mathematical Modeling of Antimicrobial Efficacy

Simple mathematical models are easy to create. Under certain circumstances they are very accurate. For example, let us consider the well known model people use to predict the velocity of an object as it falls to earth at sea level in a vacuum: velocity = 9.8 meters per second, per...

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Introduction to Bacteria, Viruses, Fungi, and Parasites

Viruses With the exception of newly discovered prions, viruses are the smallest agents of infectious disease. Most viruses are exceedingly small (about 20 - 200 nanometers in diameter) and essentially round in shape. They consist of little more than a small piece of genetic material surrounded by a thin protein...

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Log and Percent Reductions in Microbiology and Antimicrobial Testing

To keep the individual numbers manageable, microbiologists usually express them using scientific notation. Similarly, when calculating the magnitute of the change in cell number, microbiologists often use a logarithmic scale (log scale). Simply speaking, taking the log value of a large number, such as the number of cells killed in a...

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R-Water Success Story

R-Water's popular disinfectant, TK60, and powerful cleaner, FC+, have a unique chemistry that is produced on site and ready to use in minutes. Both their disinfectant and cleaner are conveniently made in one of their ready-to-use machines, the TC-RU and the TC-230, and utilizes the chemistry of electrolyzed water....

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Trends In High-Level Disinfectants

Where Can the Historical and New Data Sets be Found? FDA has two posted data sets, 2009 and 2015. The 2009 data set is found here and the 2015 data set is found here.   What Changed Between 2009 and 2015? Between 2009 and 2015, six new high-level disinfectants were added to FDA's...

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Regulation of Hard Surface Disinfectants by EPA

In the United States, disinfectants and sanitizers intended for use on environmental surfaces must be registered with the Environmental Protection Agency (EPA). EPA regulates disinfectants as "antimicrobial pesticides," via the Antimicrobial Division, within the Office of Pesticide Programs. Jennifer McLain currently serves as director. EPA's Antimicrobial Division maintains a...

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Explanation of the FDA Re-Use Test for High-Level Disinfectants

Many High Level Disinfectants (HLDs) are intended to be re-used, meaning that the same fluid disinfects several critical or semi-critical medical instruments each day for weeks.  Accordingly, FDA requires re-usable products to be “stressed” to worst-case conditions prior to efficacy testing. The re-use test is a critical part of any...

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Introduction to EPA Antimicrobial Device Regulation

The EPA rules that apply to antimicrobial products vary by type.  Antimicrobial product types include bacteristats, fungistats, disinfectants, virucides, fungicides, antimicrobial devices, and treated articles.  Of those groups, one of the most broad, innovative, and commercially active is antimicrobial devices, which are also known as antimicrobial pesticidal devices. The antimicrobial...

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Understanding the Clinical In-Use Test

If your company's high-level disinfectant research and development phase is complete and you have finished all of the GLP in vitro efficacy tests required by FDA, then you are ready to conduct the final test, the clinical "in-use" test. Passing this test proves that your product will perform under...

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Introduction to Materials Compatibility Testing

Active ingredients, surfactants and solvents present in household and medical disinfectants can damage surfaces and textiles over the course of time. For example, bleach destroys pigments present in certain textiles and acidic household disinfectants can corrode metals or dissolve unsealed granite. When a disinfectant is incompatible with the substrate to...

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EPA Lower Certified Limit Testing Requirement

The United States Environmental Protection Agency (EPA) recently updated guidelines for antimicrobial efficacy testing. Formerly, EPA required the main tests for disinfection to be performed on several batches of product, with at least one batch aged for a minimum of 60 days.  The new guidelines do not change the...

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Introduction to High Level Disinfectant Testing

High-Level Disinfectants (HLDs) are used in healthcare to kill microorganisms on medical devices such as endoscopes, ultrasonic probes, and cardiac catheters, in order to prevent the transmission of infectious diseases.  HLDs are often formulated with aldehydes, peroxides, and peracetic acid.  All HLDs are heavily regulated by FDA. The photo below...

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