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Expanded Biofilm Services

BioScience Laboratories Helps Identify the Next Generation of Anti-Bacterial Solutions Through Expanded Biofilm Testing
Companies developing anti-biofilm products should consider upcoming EPA guidance for substantiating claims
BOZEMAN, MT – JUNE 14, 2017 – BioScience Laboratories (BSLI) is helping antimicrobial product development companies better illustrate their product efficacy by expanding its…
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What Equivalence Means

Traditional statistics are used in trying to find differences between two products. In the medical field, equivalence has become a goal. For example, a test product is very expensive and another product is inexpensive. The goal is to discover if they are equivalent so the cheaper one can be sold.…

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Statistics, or How to Meet FDA Requirements


In 1994, the Food and Drug Administration (FDA) released the Tentative Final Monograph (TFM) requiring the product’s average reductions to meet the log10reduction requirements.  Later, they changed this to the lower bounds of the 95% confidence intervals.  Then they added the 70% responder rates. Both test and control…

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BioScience Laboratories, Inc. Biofilm Testing Capabilities

Biofilms are present in a broad range of industrial, environmental, human health, energy production, and agricultural systems. A biofilm is a group of microorganisms that adhere to a surface and generate an extracellular matrix, which can contain extracellular DNA, proteins, and polysaccharides. These cells embedded in biofilms are often physiologically…

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ISO 17025 ACCREDITATION

On May 31, 2016, BioScience Laboratories, Inc (BSLI), was granted accreditation to ISO/IEC 17025 (2005) by American Association of Laboratory Accreditation (A2LA), an internationally recognized accrediting body.

Today’s increasing globalization of markets is resulting in both more competition, and new opportunities for testing facilities such as BSLI.  The World Trade…

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Determining the Sample Size Necessary to Pass the TFM Pre-Operative Skin Preparation

How can one predict the sample size of subjects needed to pass the current FDA’s requirements for the preoperative skin preparation with the two recent additions (95% confidence intervals and 70% responder rates)?  The purpose of the sample size formula presented by the Food and Drug Administration (FDA) is to…

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Why Do Companies Use the Health Care Personnel Handwash Study to Evaluate their Products?

Written by Dr. Daryl Paulson, MBA, President & CEO
experts@biosciencelabs.com

The Food and Drug Administration (FDA) regulates the healthcare industry, and one of the requirements for a healthcare personnel handwash requires manufacturers to prove their products are effective in the reduction of bacteria.  That reduction needs to be a…

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Anti-Biofilm Technologies: Pathways to Product Development

This conference served as an excellent opportunity to address difficulties in the antimicrobial and infection prevention industries. Most notably, product development and testing required by the regulatory agencies were discussed, along with the lack of direction for marketing claims and FDA/EPA acceptance of anti-biofilm products. Additionally, the process of Pre-Submission…

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Russell Griggs, M.S., Presents Poster at AORN 2016

BioScience Laboratories, Inc. is very pleased to announce that one of our Principal Investigators, Russell Griggs, M.S., will be presenting a poster at this year’s AORN Conference in Anaheim, CA, April 2nd – 6th 2016. The poster session will be April 4th from 12pm – 1pm. We hope you can…

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Neutralizing Your Product(s)

BioScience Laboratories, Inc. works in the customer service environment dealing with  in-vitro and in-vivo (clinical efficacy) evaluations of many simple and complex  antimicrobial products.  One of the most critical aspects of a study’s performance is providing useful and sufficient neutralization/inactivation of the products being tested.  In brief, proof of neutralization…

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Materials Testing: Are You Stressed Out?

Materials testing is defined as the measurement of the characteristics and behavior of substances under various stressful and non-stressful conditions. The data obtained is often used in specifying the suitability of materials for various applications.  Most materials are at some point tested for their ability to perform their intended task. From…

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New Dedicated Materials Testing Lab

BioScience Laboratories, Inc. was built upon the backbone of antimicrobial testing services.Over the past 24 years BioScience has developed an ever-expanding list of available testing services including, but not limited to disinfectant studies, wound care testing, safety and efficacy testing, medical device testing and testing a wide array of personal…

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How Industry leaders are approaching new Healthcare Antiseptic Standard

On May 1st, the Food and Drug Administration (FDA) published an amendment to the Tentative Final Monograph (TFM) for Healthcare Antiseptics which will have widespread ramifications for members of the topical antimicrobial industry.  The FDA specified new efficacy criteria that are more stringent than the 1994 TFM.  A discussion of…

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Regulatory Acceptance of Three-Dimensional Tissue Constructs for Testing of Eye Irritation

An In-Vitro method for assessment of Ocular Irritation potential of chemicals has been recently accepted by the regulatory authorities as an alternative to in vivo Draize rabbit eye irritation test.  This alternative method utilizes reconstructed human cornea-like epithelium which closely mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium.…

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What People are Saying...

John (Dyba), seldom in recent memory have I experienced the level of integrity and commitment we have experienced working with you and your team.  Please pass our gratitude on to your team and tell them how much we enjoy working with such a professional organization.”

Russell Altman, Owner, Beneficial Solutions, LLC

There was absolutely no comparison between the kind of service and expertise I obtained from BioScience compared to the competition. It was obvious I had to place studies with BioScience Laboratories." 

Joel Ivers, Union Springs Pharmaceuticals.