A Closer Look at Product Quality and the Role of Preservation and Preservative Testing

Pharmaceutical and cosmetic manufacturers are required to do extensive testing to ensure their products are safe for consumers. One such test is the Preservative Effectiveness Test (also known as the Antimicrobial Effectiveness Test) which is used to demonstrate the capability of preservatives that are incorporated into drugs, cosmetics and various household products to ascertain product quality for the life of the product. Microbiologics asked Dr. Phil Geis, a 30-year veteran of the pharmaceutical microbiology industry and founder of Geis Microbiological Services, to share his knowledge on the important topic of preservation and preservative testing and the role they play in product quality.

Dr. Geis earned a PhD in microbiology and mycology from the University of Texas. His career in microbiology began at a clinical lab in the US Army, moving to commercial media production, and in 1981 to The Proctor & Gamble Company (P&G).  Through almost three decades with P&G microbiology, Phil managed preservative and disinfectant development and studies of household and skin microbial ecologies and hygienic manufacturing. He was the first recipient of P&G’s namesake award – Dr. Philip Geis Microbiology Quality Award. Dr. Geis brings unique global expertise and experience in diverse regulatory, manufacturing, product quality and consumer realities for a broad range of products from OTC drugs to fabric softeners to dog food.

In this article, Dr. Geis discusses the importance of preservatives for maintaining product quality, the different types of preservatives used in the pharmaceutical and cosmetic industry, and the preservative effectiveness test. 

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 It's Turkey Time

Roasting a turkey this holiday season? Don't fowl it up! The responsibility of preparing a delicious and SAFE holiday meal for your family and friends can be overwhelming, whether you're a seasoned veteran or a first-timer. Roasting a turkey can be especially intimidating; maybe you've heard a few horror stories of turkey feasts gone wrong. Certainly foodborne pathogens are at the top of everyone's 'Most Unwanted' list of guests for any holiday celebration. Before fear and panic set in, we have a few general tips that will help you plan and prepare a safe and special holiday meal to be thankful for! 

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Microorganisms Spreading the Holiday Cheer

This holiday season, as you open a bottle of your favorite wine to share with family and friends, consider making a toast to Saccharomyces cerevisiae (also known as "brewer’s yeast") which is a species of yeast that is commonly used for making wine and beer. Yeast is absolutely essential to winemaking. The Latin meaning of Saccharomyces is "sugar fungus". Through the process of fermentation, S. cerevisiae converts the natural sugars present in grape juice to carbon dioxide and ethanol (alcohol), and thus wine is produced. Read the full article to learn more about the process of fermentation and winemaking.

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 Microbiologics is Expanding

Microbiologics broke ground on a 19,200 square foot expansion this September, nearly doubling the size of the existing building, at our corporate headquarters in Saint Cloud, Minnesota. Since then, our days have been anything but quiet! Crews have been on site each day, hard at work on our new addition. The new two-story building will include a reception area, many offices and work spaces, several conference rooms, a large shipping and warehouse area, as well as an area for employee functions. Renovations will also be completed to improve production and packaging areas in our existing building.

Microbiologics Chief Executive Officer, Brad Goskowicz, commented, “With this new building expansion, and the improvements to our existing building, Microbiologics is going to be even more efficient than we are today. We are redesigning our production, packaging, and shipping areas to streamline the manufacturing process and get orders out the door faster, and all of our administrative departments will be located in one central area to create a more organized work environment.”

The new addition is scheduled for completion in April 2012. We’ll keep you posted on the progress!

 Meet Our Team

From left to right: Amanda Wood, Amanda Kuperus, Jennie Holub and Beth Zenzen

The Microbiologics Industrial Quality Control team is built of trained microbiologists. They are responsible for testing and identifying all enumerated products manufactured at Microbiologics. The laboratory operates under a number of accreditation standards in order to provide the best quality products to our customers.

 LAB-ELITE™ CRM Update

To provide our customers with greater value, we have eliminated the additional "Sample Analysis" and "PFGE Sub-Typing" reports that were originally included with Lab-Elite CRM. Market feedback indicated that there is limited demand for the information provided on the reports, so we decided to make it more affordable for you to use Certified Reference Material.

Lab-Elite™ is still Certified Reference Material because of the homogeneity testing we perform and because the Certificate of Analysis is included in the canister with the product as required by ISO Guide 34 per our A2LA accreditation. As an ISO Guide 34 accredited manufacturer, Microbiologics offers Lab-Elite™ Certified Reference Materials to help ISO 17025 accredited laboratories meet the requirements of this standard. ISO 17025 Section 5.6.3.2 states, “Reference materials shall, where possible, be traceable to SI units of measurement, or to certified reference materials”.

Click here to download a new Lab-Elite™ CRM flyer. For more information, feel free to contact us by calling 320.253.1640 (U.S. Toll Free 800.599.2847), or send an email to info@microbiologics.com. Or contact an authorized Microbiologics distributor in your area!

Word on the Streak!

Here are a few interesting facts about some microorganism strains from our catalog.

1. Looking for a NAP1 positive strain of C. difficile? Microbiologics catalog # 01048, Clostridium difficile ATCC® BAA-1870™*, is PFGE Type NAP1, Toxinotype III, and Binary Toxin positive.
2. A test microorganism for commonly used culture media listed in ISO 11133:2009 is Microbiologics #01075, Pediococcus pentosaceus ATCC® 33316™*. It should be grown in MRS broth or on MRS agar.
3. Microbiologics catalog # 01064, Escherichia coli ATCC® 33849™*,  is a plasmid host strain with a high transformation frequency.  For more information on this microorganism see  "Hanahan D. Studies on transformation of Escherichia coli with plasmids." J. Mol. Biol. 166: 577-580 1983. PubMed.

FREE Microbiologics T-Shirt!

Receive a free Microbiologics T-Shirt when you order $500 or more of Microbiologics® products! Just mention this ad when placing your order and we'll include a T-Shirt with your shipment – FREE!

Click here to download a brand new version of the Microbiologics Quality Control Microorganism Products Catalog! (PDF/19 MB)

Dear Laurie is an advice column written by Microbiologics Technical Support Specialist, Laurie Kundrat. Laurie received a Biology degree from Case Western Reserve University and earned a Medical Technology degree from Fairview General Hospital. With over 25 years of experience as a microbiologist, Laurie has grown to love all types of bacteria and she also loves talking to customers and helping them use Microbiologics® products successfully.

If you would like Laurie's advice on a microbiology related problem you're experiencing, click here to submit your question to her.

Dear Laurie,

I need to determine the suitability of my counting method for the microbial enumeration test. I am using the membrane filtration method. Which product should I use?

~ Counting on you in Phoenix, Arizona

Dear Counting,

I recommend using EZ-CFU™, EZ-CFU™ One Step or EZ-Accu Shot™ for determining if your counting method is acceptable.  All three products deliver <100 CFU per 0.1 ml when hydrated according to directions.  To perform the test, inoculate two samples in parallel with 0.1 ml from the same suspension of microorganisms.   One sample should contain the diluted product. The other sample should contain diluent without the product.  Filter each sample at least in duplicate and incubate the filters on agar.

In order for the counting method to be deemed acceptable, the number of colonies recovered in the presence of the product should be within a factor of two of the number of colonies without the product.  If the number of colonies is not within a factor of two, the antimicrobial properties of the product will need to be neutralized.  Consult your pharmacopeia for more detailed instructions.

~ Laurie Kundrat

Microorganism Name Change Letters Did you know Microbiologics offers letters of explanation for many microorganisms that have changed names? Customers use the letter(s) as documentation for auditing purposes. Click here for a list of microorganism name change letters from Microbiologics.

Microbiologics QC microorganism products are utilized in microbiology laboratories worldwide; over 130 countries! How well do you know the great landmarks of the world? Find out by playing the Microbiologics World Landmarks Matching Challenge!

Arab Health 2012
January 23 - 26, 2012
Dubai International Convention & Exhibition Centre
Dubai, United Arab Emirates

It is important to use the microorganism controls recommended by the manufacturer when using the Cepheid® GeneXpert or SmartCycler, the Roche LightCycler®, or the BD GeneOhm™ because some tests require specific concentrations of organisms.  For example, when testing Staphylococcus epidermidis on the GeneXpert, it is important to use S. epidermidis, 0371 MSSE (the negative control for MRSA testing) rather than the qualitative product, 0371P.  Using 0371P may lead to aberrant results because it contains about 4,000 times the number of colony forming units as 0371 MSSE. 

In response to customer requests, we have made some exciting improvements to our EZ-Accu Shot™ and EZ-Accu Shot™ Select product kits. Microbiologics now includes a new set of hydrating fluid labels with EZ-Accu Shot™ and EZ-Accu Shot™ Select kits. Now you will be able to place the extra label on the hydrating fluid vial after the lyophilized microorganism pellet has been added, for quick and easy identification. Each kit will include a strip of 5 of the new hydrating fluid labels which are pale green and feature a space for you to write in the microorganism name and the time that the pellet was hydrated. This allows you to keep track of the remaining time to perform Growth Promotion Tests (EZ-Accu Shot™ and EZ-Accu Shot™ Select can be used for up to 8 hours after hydration, when refrigerated between uses).

EZ-Accu Shot™ and EZ-Accu Shot™ Select are not intended for clinical use.

Check out our new Catalog Supplement, listing all of the new microorganism strains we have added to our product lines!

Click here for an easy to follow recipe for this delicious Pumpkin Cake Roll with Cream Cheese Filling. It's a great holiday treat - and also makes a tasty gift!