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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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:...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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....

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...