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Maximal Usage Trial

BACKGROUND: Since the 1970s, FDA approval of a new drug requires an evaluation of the in vivo bioavailability of the drug, as part of the
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Cosmetic Product Testing Capabilities

The BioScience Laboratories Cosmetic Testing Laboratory offers clinical testing services for both personal and professional skin care products. Standard, validated protocols have been developed to
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ASTM - D2979

The ASTM D2979 test method provides a quantitative measure of the pressure-sensitive tack of the adhesive.  The method is designed to evaluate the adhesive
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Subjective Product Claim Support

50 Subject Panels for Subjective Product Claim Support BioScience Labs can help generate data to support product claims for in-home use over time. Consumer preference claims
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Viral Clearance

BioScience Laboratories' Virology lab performs Viral Clearance studies to provide safety data for biopharmaceutical products or medical devices that are derived from human or
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Disinfectant Validation

Disinfectant Validation Studies are an FDA requirement to demonstrate the broad-spectrum antimicrobial efficacy of one or more disinfectant products employed for pharmaceutical production area qualification
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ASTM E2946

Standard test method for: Determining the Bacteria-Reducing Effectiveness and Food-Handler Handwash Formulations Using Hands of Adults During testing, subjects will contaminate hands with E.
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Plaque Glycolysis and Regrowth Model (PGRM)

The Plaque Glycolysis and Regrowth Model (PGRM), a predictive ex vivo model, evaluates the clinical effectiveness of antimicrobial (anti-plaque and anti-gingivitis) agents on plaque biofilms
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ISO 22442-3

Medical devices utilizing animal tissues and their derivatives – Part 3:  Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE)
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Blood Glucose Monitoring Systems: Cleaning & Disinfection Procedure Validation

BioScience Laboratories Inc. conducts the FDA-required validation of cleaning and disinfection procedures.  Each evaluation will include the following FDA requirements: Selection of an EPA-approved
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EP 5.1.3

The European Pharmacopeia describes in General Text 5.1.3, the assay they recommend for testing preservative efficacy. The EP divides products into three tables: 5.1.3-1 - Parenteral
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OECD 492

Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage  This method
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OECD 435

In Vitro Membrane Barrier Test Method for Skin Corrosion This method describes an in vitro membrane barrier test method that is used to identify corrosive
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Biofilm Testing Laboratory

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ISO 11930

The International Organization for Harmonization is designed for cosmetic formulations. Unlike the USP 51 or EP 5.1.3, ISO does not divide products into different categories. Test products
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ASTM F2256

 Strength Properties of Tissue Adhesive by T-Peel Loading This test method provides a means for comparison of tissue adhesives strengths intended for use as
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ASTM F2258

Tensile Strength of Tissue Adhesives   This test method provides a means for comparison of tissue adhesives strengths intended for use as surgical adhesives and
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ASTM D6195

Adhesive Loop Tack Strength Test This standard test method is used to determine the tack strength of pressure sensitive adhesives.  This method can be
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ASTM D1876

 T-Peel Test This test method is designed to determine the relative peel resistance of your tape adhesive to flexible surfaces.  This method can
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ASTM D3330

Peel Adhesion of Pressure Sensitive Tape This test method is a tool for quality assurance to provide data regarding the requirements for a minimum and
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ASTM D903

Peel or Stripping Strength of Adhesive Bonds This standard test method is used to determine the comparative peel or stripping strength of adhesive bonds when
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JIS L1902

Determination of Antibacterial Activity of Antibacterial Materials This standard test method evaluates the antibacterial activity of antibacterial finished textile products including woven and non-woven material.
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ASTM D3574

Sections E & F Tensile Test & Tear Resistance Test These test methods are designed to test the strength of flexible cellular materials, specifically &ldquo
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ASTM D3330/D3330M

Adhesive Strength Testing These test methods are used on pressure-sensitive tapes to show the relative bond strength of a given tape to one or more
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ASTM D5035

Dry Strength Testing and Wet Strength Testing   This test determines the breaking force and elongation of textile fabrics used for dressing or bandage material.
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EN 13726-4

Conformability This test method provides measures of the resistance to stretching, and the dressing’s ability to return to its original shape.  The
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EN 13726-3

Waterproofness   This test method provides information on wound dressings that act as a barrier to moisture entering a wound.  This test method places
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EN 13726-2

MVTR Testing   Moisture Vapor Transmission Rate test is performed on primary wound dressings to help you determine the effects of moisture on the wound
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EN 13726-1

Absorbency Testing   Wound dressings are used to soak up or remove excess fluid.  This test determines the amount of fluid the dressing can
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Colony Biofilm Method

Biofilms in a Zero-Shear Environment BioScience Labs provides services for evaluation of product efficacy in the prevention and/or removal of biofilms using in-vitro techniques.
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ASTM E2647

Drip Flow Reactor Protocol BioScience Labs provides services for evaluating product efficacy in the prevention and/or removal of biofilms using in-vitro techniques. This
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ASTM E2799

MBEC Reactor Protocol BioScience Labs provides services for evaluating product efficacy in the prevention and/or removal of biofilms using in-vitro techniques.  This method
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ASTM E2871

Single Tube Method BioScience Labs provides services for evaluating product efficacy in the prevention and/or removal of biofilms using in-vitro techniques. This method
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ASTM E2562

CDC Biofilm Reactor Protocol BioScience Labs provides services for evaluation of product efficacy in the prevention and/or removal of biofilms using in-vitro techniques.  
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Bovine Corneal Opacity and Permeability (BCOP)

The Bovine Corneal Opacity and Permeability (BCOP) test is an in-vitro method to evaluate chemicals inducing serious eye damage or serious eye irritation.  This
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Sensitization Testing

BioScience Laboratories performs sensitization testing by the Modified Draize test in accordance with the FDA/CDER Guidance for Industry, Skin Irritation and Sensitization Testing, December 1999.
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Moisturization Testing

Assessing your product's ability to moisturize the skin is commonly performed at BioScience Laboratories. Using various specialized bioinstrumentation, including: TEWL, Corneometer, Mexameter, Visoscan &
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ISO 10993-5

Biological Evaluation of Medical Devices This test method describes methods to assess the in-vitro cytotoxicity of medical devices. These methods specify the incubation of cultured
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ASTM - E2870

Standard Test Method for Evaluating Relative Effectiveness of Antimicrobial handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling This test method covers and is
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OECD 437

Bovine Corneal Opacity and Permeability (BCOP) Test Method for Identifying Ocular Corrosives/Severe Irritants and Substances not Classified as Irritants The Bovine Corneal Opacity and
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AOAC 955.14, 955.15, and 964.02

Use Dilution Method These standard methods test the efficacy of disinfectants against three standard bacteria on hard surfaces.  These standard tests are used for
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ASTM - E2406

Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants for Use in High Efficiency Washing Operations This test method is designed to evaluate sanitizing
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ASTM - E2274

Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants This test method is designed to evaluate sanitizing/disinfectant laundry detergents/additives for use in
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ASTM - E2362

Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection This test method may be used to determine if a pre-saturated
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CLSI M07-A10

Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically Susceptibility testing is indicated for any organism that contributes to an infectious process warranting
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EN 14476

Quantitative Suspension Test for the Evaluation of Virucidal Activity in the Medical Area This European Standard specifies a test method and the minimum requirements for
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AATCC - 100

Antimicrobial Finishes on Textile Materials This test method provides a quantitative procedure for the evaluation of the degree of antibacterial activity. Assessment of antibacterial finishes
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ASTM - E2149

Standard Test Method for Determining the Antimicrobial Activity of Antimicrobial Agents Under Dynamic Contact Conditions This test method is designed to evaluate the antimicrobial activity
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EN 14348

Quantitative Suspension Test for the Evaluation of Mycobactericidal Activity of Chemical Disinfectants in the Medical Area Including Instrument Disinfectants  This document specifies a test
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EN 13624

Quantitative Suspension Test for the Evaluation of Fungicidal Activity of Chemical Disinfectants for Instruments used in the Medical Area This European Standard applies to products
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EN 13727

Quantitative Suspension Test for the Evaluation of Bactericidal Activity in the Medical Area This European Standard applies to products that are used in the medical
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ASTM - E2783

Standard Test Method for Assessment of Antimicrobial Activity for Water-Miscible Compounds Using a Time-Kill Procedure This test method measures the changes of a population of
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ASTM- E1054

Standard Test Method for Evaluation of Inactivators of Antimicrobial Agents The effectiveness of antimicrobial agents incorporated into disinfectants, sanitizers, and antiseptics is measured by their
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ASTM - E2752

Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products This guide is designed to demonstrate the effectiveness of an antibacterial personal cleansing
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ASTM - E2011

Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand This test method is designed to evaluate
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ASTM - E1838

Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults This test method is designed to
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EN 12791

 Surgical Hand Disinfection This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical hand disinfection reduces the
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EN 1499

Hygienic Handwash This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handwash (water-aided) reduces the release of
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EN 1500

Hygienic Handrub This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub (leave-ons) reduces the release of
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OECD 439

In-Vitro Skin Irritation: Reconstructed Human Epidermis Test Method This method is based on reconstructed human epidermis, which closely mimics the properties of the upper layers
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OECD 431

In-Vitro Skin Corrosion: Human Skin Model Test In this method, the test material (solid or liquid) is applied to a three-dimensional human skin model and
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Injection Site Protection

Injection sites are a common source of nosocomial infections. Proper pre-treatment and prophylaxis of these sites is important to reducing healthcare costs and improving 
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Dermal Irritation Testing

The EpiDerm™ Skin Model uses a culture of normal human-derived epidermal keratinocytes that forms a multi-layered model of the human epidermis. This model is
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Cumulative Irritation Evaluations

BioScience Laboratories Skin Technology Center performs clinical evaluations for cumulative skin irritation in accordance with the FDA/CDER Guidance for Industry,
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Hydration Property Testing for Wound Dressings

Studies using human subjects (intact skin) to determine the effectiveness of dressings in maintaining or augmenting skin hydration over time (e.g., alginates, foams, hydrocolloids,
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Bandage Material Physical Properties

The Materials Testing Lab features temperature and humidity control along with the ability to test for the following product characteristics: Tensile Strength Peel Adhesion Our
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Bandage and Wound Care Absorbency Testing

We possess the equipment and facilities to evaluate the absorbency and vapor permeability of bandage and wound care dressings. 
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Wound Healing Evaluations

Evaluations of rate of cell proliferation, measured as a function of cellular protein expression (e.g., growth factors) in a 3-D model of wound reepitheliazation.
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First Aid Wound Management

In-vitro evaluations as described under II-A, and as follows: Screening zone-of-inhibition studies. Studies per methodology prescribed by the FDA: 21 CFR Sections 333 and 369, “Tentative Final
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In-Vitro Wound Management Evaluations

In-vitro evaluations of antimicrobial properties versus ATCC or clinically isolated strains of bacteria relevant to surgical-, burn-, and catheter-related infections. Time-Kill Kinetic studies (planktonic and
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EN 13697

Quantitative Non-Porous Surface Test for the Evaluation of Bactericidal and/or Fungicidal Activity of Chemical Disinfectants Used in Food, Industrial, Domestic and Institutional Areas This
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EN1276

Quantitative Suspension Test for the Evaluation of Bactericidal Activity of Chemical Disinfectants and Antiseptics used in Food, Industrial, Domestic and Institutional Areas This European Standard
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EN 1275

Quantitative suspension Test for the Evaluation of Basic Fungicidal or Basic Yeasticidal Activity of Chemical Disinfectants and Antiseptics This European Standard applies to active substances
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EN 1040

Chemical Disinfectants and Antiseptics- Quantitative Suspension Test for the Evaluation of Basic Bactericidal Activity of Chemical Disinfectants and Antiseptics This European Standard applies to active
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AOAC 965.13

Disinfectants (Water) for Swimming Pools This standard test method recommended by the EPA provides efficacy data for Test Products designed to disinfect spa and pool
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Virucidal Disinfectant Testing

These tests are designed to provide virucidal efficacy data for disinfectant products challenged with various viruses.  Testing is performed based on a
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EN1650

Quantitative Suspension Test for the Evaluation of Fungicidal activity of Chemical Disinfectants and Antiseptics Used in Food, Industrial, Domestic and Institutional Areas This method describes
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ASTM- E1153

Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces This test method is used to evaluate the antimicrobial efficacy of sanitizers
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ASTM - E2197

Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals This test method is designed to evaluate the
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AOAC Germicidal Towelette Test

This standard method evaluates the efficacy of towelette disinfectants according to ASTM E2362-09 based on EPA SOP’s.  BioScience Labs offers this
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AOAC 966.04

Sporicidal Activity of Disinfectants This standard method tests the efficacy of disinfectants against spore-forming bacteria on hard surface carriers.  This standard test is suitable
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AOAC 960.09

Germicidal and Detergent Sanitizing Action of Disinfectants Test This standard test method tests the efficacy of food contact sanitizers against S. aureus and E. coli.
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AOAC 955.16

Chlorine (available) in Disinfectants; Germicidal Equivalent Concentration  This standard test method provides efficacy data that demonstrates equivalent performance of Test Product equivalent concentrations to
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AOAC 965.12

Tuberculocidal Activity of Disinfectants This standard test method recommended by the EPA demonstrates efficacy on hard non-porous surfaces against M. bovis.  BioScience Labs offers
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AOAC 961.02

Germicidal Spray Products as Disinfectants This standard test method recommended by the EPA provides efficacy data for Test Products designed as germicidal spray products.
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AOAC 955.17

Fungicidal activity of Disinfectants' Using Trichophyton Mentagrophytes This standard test method recommended by the EPA provides efficacy data for Test Products designed as disinfectants with
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Disinfectant and Sanitizer Testing Services

BioScience Laboratories has streamlined our processes, as well as our pricing structure to better meet the expectations of our customers. We now have an accelerated
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MIC/MBC Testing

Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC) testing define a test material's potency in terms of the concentration at which it will
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Cup Scrub for Persistence

This antimicrobial effectiveness testing may be used to evaluate if a test product has persistent log10 reductions post application. This post-application evaluation may be
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ASTM - E1882

Standard Test Method for Evaluation of Antimicrobial Formulations by the Agar patch Technique This procedure can be used to evaluate formulations containing ingredients intended to
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Surgical Scrub

Surgical scrub formulations are designed to remove both the transient microorganism population as well as a large proportion of the normal endogenous microorganism population residing
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Time-Kill Kinetics - Antimicrobial Efficacy Test

Time-Kill In Vitro assay tests are referred to as “suspension tests” because a measured volume of the suspension of challenge bacteria
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Zone of Inhibition

This diffusion test is used to evaluate the static/cidal activity of water-soluble, leachable antimicrobial formulations that will diffuse into an nutrient agar
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Personal Care Products Council (PCPC)

Preservation Testing of Water-Miscible Products Challenge testing a formula with known microorganisms to verify that if the products become contaminated, the preservative system is
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ASTM - E640

Standard Test Method for Preservatives in Water-Containing Cosmetics This test method covers the determination of the suitability of preservatives for use in cosmetic formulations. It
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USP 51

ANTIMICROBIAL PRESERVATIVE EFFECTIVENESS TEST (PET) The U.S. Pharmacopeia describes in General Chapter 51, the assay they recommend for testing preservative efficacy. The USP divides products
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Antimicrobial Preservative Efficacy Testing

Antimicrobial Effectiveness Tests, or Preservative Effectiveness Tests, are performed to determine the efficacy of the antimicrobial preservatives added to many pharmaceutical and cosmetic products to
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Pre-Operative Skin Preparation

The FDA has a process in place for formal evaluation of the results of these studies. Also of note is that ASTM's Standard Method
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ASTM E1173

Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations These procedures should be used to test topical antimicrobial-containing preparations that are intended
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Food Handlers Handwash

BioScience Laboratories uses the approved ASTM E2946-13 method as well as other methods to conduct these studies. Subjects contaminate hands with E.
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