DEDICATED LABS

Aerobiology

In 2004 MICROBIOTEST doubled the size of its original facility with the addition of the most technologically advanced Aerobiology laboratory in the private sector. MICROBIOTEST is now one of the leading airborne microorganism research facilities in the world.

The new Aerobiology Division underscores the elite distinction that MICROBIOTEST is a comprehensive resource for a broad array of investigative studies of microorganisms that represent potential or known risks of airborne transmission. Potential pathogens are subject to thorough customized analysis to determine the efficacy of client-developed agents or methodologies designed to detect, trace route of transmission or inactivate aerosolized pathogens.

This technology is anticipated to transform current methodologies utilized by universal public health, agricultural, and livestock specialists to develop inactivation or inhibitory protocols for microbial pathogens. MICROBIOTEST is uniquely positioned to support the scientific community in insuring a safer environment protected from naturally-occurring or deliberately-introduced microbial threats.

Bacteriology

Bacteria are ubiquitous, and life as we know it could not exist without these microorganisms. Yet many types of bacteria produce illness and disease, which sometimes result in death. The desire to control bacterial growth and eliminate harmful organisms has prompted and guided the development of sterilants, disinfectants and sanitizers within the Industry.

Be it an antiseptic, a disinfectant or a preservative, the effective inactivation of microorganisms through the use of these vehicles comprises the basis of the investigative testing performed by MICROBIOTEST. The methods used in our laboratories for evaluating antibacterial activity are critically assessed not only by our staff but also by our colleagues in academia and in the regulatory agencies as well.

Many types of antimicrobial agents exist and, depending on their intended uses, may be controlled or managed differently by separate regulatory agencies - federal, state, and foreign authorities. MICROBIOTEST has extensive experience with the varied regulations and the formats of our protocols and final reports are consistent with the particular requirements of the regulating agency.

EPA
FDA

Biofilms

Bacterial biofilms are micro colonies encased in slime (extracellular polysaccharide material), resulting from the adherence of bacteria to a surface both in vitro and in vivo. Before the 1980s, biofilms were simply viewed as slime accumulating on surfaces of natural water sources. As the science of biofilms began to evolve, it became very apparent that these bacterial matrices are not limited to finite habitats; they are appearing in areas that were not previously considered to be sustaining environments. In addition, biofilm colonies are configured in such a way as to make many forms impervious to eradication via standard antibacterial disinfection methods.

As such, the control of biofilms is increasingly becoming recognized as a paramount concern for all types of industry around the world.

• Dentistry -- contaminated dental unit waterlines
• Medical field -- contaminated reusable and colonized indwelling medical devices
• Contact lens manufacturers -- biofilms causing bacterial infections of the eye (Please see Contact Lens Regimen under Testing Services)
• Disinfection industry – development of products to inactivate or eradicate biofilms
• Industry and municipal authorities -- oil, sewage and water pipe fouling
• Veterinary microbiological programs -- colonized indwelling veterinary devices, contaminated milking machines, etc.

At MICROBIOTEST we actively sponsor research and development to refine methods for testing antimicrobial products for their potential to prevent biofilm development or to eradicate biofilm communities after formation. Depending upon the intended application and use pattern, customized biofilm generation methods will be tailored to evaluate the anti-biofilm efficacy of chemical formulations and test products; and testing is conducted using our state-of-the-art bioreactor to generate thorough, accurate test data.

Clinical Microbiology

In the development of antiseptic skin products, in vivo studies play a critical part in gaining FDA approval. The selection of a testing laboratory to conduct these crucial tests must take into account the experience, performance and credibility of the contract laboratory. MICROBIOTEST is the ideal choice because performance, data integrity and quality assurance are the foundation of all tests performed at our laboratories.

Clinical clients benefit from quality service because MICROBIOTEST's staff is highly trained in the FDA's Tentative Final Monograph (TFM) as well as all accepted American Society of Testing and Materials (ASTM) clinical trial methods. The knowledge of the staff combined with the extensive clinical experience MICROBIOTEST has acquired over the years will offer optimum results.

Since all clinical testing protocols must first be approved by an Institutional Review Board (IRB), MICROBIOTEST maintains its own IRB to offer its clients quick accurate protocol approval while also protecting the confidentiality and safety of its volunteers. Our highly-qualified panel reviews the protocols and testing methods for each study; in addition they ensure informed consent through the evaluation and approval of the informed-consent document. The commitment of the IRB guarantees the protection of all participants of the clinical studies. By maintaining its own IRB and quality assurance unit, MICROBIOTEST strives to avoid costly delays by offering its clients quick and accurate protocol approval.

Below is a list of the methods that MICROBIOTEST performs for testing topical antimicrobials:

Evaluation of Healthcare Personnel Handwash Formulation	TFM	ASTM
Evaluation of a Pre-Operative Skin Preparation (surgical soap, body washes/lotion)TFMASTM	TFM	ASTM
Evaluation of Surgical Hand Scrub Formulation	TFM	ASTM
Evaluation of Alcohol-Based Hand Scrub Formulation	TFM	ASTM
Evaluation of Antibacterial Washes by Agar Patch Test		ASTM
Evaluation of antiseptic virucides on fingerpads
Modified Cade Test
Rotter (Vienna Model) [European Union - EU]
Minimum Inhibitory Concentration Determinations (MIC)* Minimum Bactericidal Concentration (MBC)* Time-Kill tests* * In vitro tests performed against the entire array of microorganisms and clinical isolates as listed in the FDA’s Tentative Final Monograph.	NCCLS

Mycology

Over the past decade and a half fungi have steadily developed into a serious public health hazard, and the science of mycology has emerged as a significant facet in the microbiological mainstream. This escalating fungal menace is keeping pace with the expanding size of the immuno-compromised patient population affected by these microorganisms. Fungi that were once thought to be non-pathogenic have evolved into an opportunist disease-causing entity capable of triggering devastating health-related reactions in many people.

In addition to the impact on health, the fungal influence has an even greater financial corollary on industry. Fungi contribute to the failure of wood preservatives and aqueous-based products used in the paper industry and can destroy adhesives, unseasoned lumber, leather, water-containing cosmetics and various synthetic polymeric materials. The overall impact on the public is profound.

The Mycology staff at MICROBIOTEST expertly performs efficacy testing against anti- fungicidal, mildewcidal and sporicidal products whether they are meant for preserving public health or for other industrial uses. Dependant upon the desired label claim, tests will be conducted using yeasts or filamentous forms of fungi as required for adherence to the EPA regulations. For non- health related products, our expert staff has broad experience conforming protocols to utilize wood (pressure-treated and untreated), adhesive tile, and various synthetic polymeric materials as carriers for specialized industry-related efficacy testing as well.

Protozoology

At MICROBIOTEST, we focus on three genera of protozoa in our testing schema. We test water purification systems for efficacy using Cryptosporidium parvum and Giardia muris (the EPA accepts G. muris as a surrogate for G. lamblia). We challenge soft contact lens solutions with Acanthamoeba ssp., oocysts and trophozoites to ascertain effectiveness against these protozoa.

The oocysts of C. parvum are commonly ingested through water contaminated by herd animals. Most infections result in symptomatic illness and commonly occur in neonates, the elderly and immunocompromised persons.

G. lamblia is the most common human intestinal protozoan pathogen in the US and is a significant cause of diarrhea in children and adults. In addition to contaminated water, outbreaks of disease are common within day-care centers as a result of person-to-person contact of the cysts.

A number of species of Acanthamoeba cause a painful vision-threatening disease of the human cornea: Acanthamoeba keratitis. If the infection is not treated promptly, it may lead to ulceration of the cornea, loss of visual acuity, and eventually blindness and enucleation. More than 500 cases of Acanthamoeba keratitis have been reported in the US. The numbers of cases per year is increasing due to increased use of daily wear and extended wear soft contact lenses and is a significant concern to health care providers.

Substantial Equivalence Testing

According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form, however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution.”

The process is lengthy and the requirements are very specific. Once a manufacturer begins the 510(k) application, testing data from an Agency-recognized laboratory will be required to substantiate the device claims. Being an FDA-recognized facility, MICROBIOTEST is the premier laboratory for testing the following products to meet the FDA requirements:

• Liquid high-level disinfectants and sterilants and the endoscopes they are meant to disinfect – including simulated use and stressing according to FDA Guidelines
• Automatic endoscope reprocessors
• Indicator strips for determining the level of active ingredient in those liquids
• Wound dressings containing antimicrobials
• Soft contact lenses and their associated disinfecting solutions

For information on the procedure, please visit www.fda.gov/cdrh/510k.html.

Viral Clearance

MICROBIOTEST has broad experience in viral clearance study design and execution. With a team of highly experienced staff members, a large virus library, an internal database of viral clearance studies and our established track record of exceptional client services, we can help you design and execute an efficient viral clearance study to meet your needs as well as regulatory requirements.

The following Viral Clearance services are offered:

• Customized Viral clearance evaluation for biopharmaceutical purification processes
• Column re-use and sanitization studies
• Validation of biopharmaceutical cleaning procedure for virus elimination
• Biomedical material cleaning/disinfection studies
• Viral storage stability studies

Our clients can rely on our commitment to deliver high-quality viral clearance services within a prompt time frame and at very competitive pricing.

Virology

MICROBIOTEST is the leader in the development and application of GLP assays for antiviral testing against a variety of human and veterinary viruses. Our virology staff has broad experience with antivirucidal efficacy testing using a variety of organisms: Avian influenza, Hantavirus, Poliovirus, Canine parvovirus and Feline panleukopenia, to name a few. Moreover, the addition of an enhanced Biosafety Level 3 (BSL-3) laboratory (October 2004) further increased our testing capabilities to include selected BSL-3 agents such as SARS-associated Human Coronavirus and Chlamydia psittaci.

Our services for Virology include:

• Evaluation of virucidal agents and systems for their effectiveness.
• Evaluation of handwash products for anti-viral activity in both institutional and industrial settings.
• Surgical face mask, water purifier and contact lens testing for virucidal efficacy
• Adventitious virus testing for biologics.
• Evaluation of pathogen inactivation systems against cell associated blood-borne viruses (as required by international regulatory guidelines)

Several of the methods developed at MICROBIOTEST are now industry standards. Of particular note is our development of novel assays for testing virucidal efficacy against:

• Hepatitis B Virus (HBV) – using duck hepatitis B virus (DHBV) as a surrogate
• Hepatitis C Virus (HCV) – using bovine viral diarrhea virus (BVDV) as a surrogate
• Human Norwalk Virus – using Feline calicivirus (FCV) as a surrogate
• Rabies
• Hantavirus

Testing Services