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Chemical / Physical Characterization – Information

Genotoxicity – Mouse Lymphoma Assay.

Carcinogenicity Study

Genotoxicity – Bacterial Reverse Mutation Study.

Subacute – Subchronic Systemic Toxicity Study Following Implant

Subacute – Subchronic Systemic Toxicity Study Following Implant.

ISO Muscle Implantation Study.

ISO Pyrogen Study – Material Mediated

Genotoxicity – Chromosomal Aberation / Mammalian Cells – Japanese MHLW

Genotoxicity – Bacterial Reverse Mutation Study – Japanese MHLW

Cytotoxicity Study – Colony Assay – Japanese MHLW

ISO-10993-18 Chemical Characterization

Biological Risk Assessment / Safety Evaluation Plan

ISO Pyrogen Study – Material Mediated.

Gram Stain and Colony Morphology

USP/NF Monograph Testing – Potentiometric Titration

ADA Oral Toxicity Study

CFR General Safety Study

Oral Mucosal Irritation Study – Surgical Method

Intravitreal Injection Study

JP Systemic Toxicity Study

USP Muscle Implantation Study

Bioburden Recovery Validation – Inoculative

Sterility-Inoculated Product

Alkaline Phosphatase Activity

Bacteriostasis / Fungistasis

Sterilization – EO Conventional Chamber

Microbiological Examination of Nonsterile Products; USP 61 Microbial Enumeration Test, and USP 62 Test For Specified Microorganisms

Preservative Effectiveness Test USP

Sterility Dose Set

USP Growth Promotion

Identification of Fungi Using an Automated Biochemical System

Bioburden Recovery Validation – Repetitive

Zone of Inhibition

Environmental Monitoring of Viable Organisms

Filter Effectiveness Study (HIMA)

AATCC Test Method 30, Part III

AATCC Test Method 100

AATCC Test Method 147

AATCC Test Method 174 Part I

AATCC Test Method 174, Part II

AATCC Test Method 174, Part III

Kirby-Bauer Susceptibility Test

Antimicrobial Evaluation Pink Stain Test

USP <1227>

USP <55> Total Viable Spore Count

ASTM E2149

DNA Microbial ID with MicroSEQ

Sterility – Membrane Filtration

Sterility-Direct Transfer Method

Sterility Positive Investigation Report

Sterility-in situ-Product

Bone Morphogenic Protein 2 (BMP-2) – In Vitro Osteoinduction Test

In Vivo Osteoinduction Assay

USP (LAL) Limulus Amebocyte Lysate Testing, Kinetic-Chromogenic

USP (LAL) Testing – Gel – Clot Method

USP (LAL) Test – Kinetic Turbidimetric Method (Pos, Neg, Inhib)

EP 3.2.9 and USP Monograph Testing

USP Glass Container Testing, Complete

USP Polyethylene Container Testing, Complete

USP Polyethylene Terephthalate Bottle Testing

JP Test for Rubber Closure for Aqueous Infusions

Gurley Method Air Permeance Determination

Visual Inspection of Medical Packaging to Determine Integrity

External Standards Testing

Preliminary Extraction Test – Japanese MHLW

Exaggerated Extraction Procedure – Japanese MHLW

Determination of Extractable Semi – Volatile Organic Compounds by GC/MS

Exhaustive Extraction

ISO Ophthalmic Implants – Intraocular Lenses: Test for Hydrolytic Stability

Chemical Residue by Gravimetric Analysis

USP <671>, Containers, Light Transmission

USP <661>, Containers – Plastics, Polypropylene Container, Complete

Blank Glassware Analysis – Analysis of Semi-Volatile Organic Residuals Gas Chromatography

ICH Stability Aging Chambers

Ultra Performance Liquid Chromatography/Mass Spectrometry (UPLC/MS)

Determination of Extractable Volatile Organic Compounds by Headspace GC/MS

Residual Acetate Determination by Ion Chromatography

Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan

Rotational Viscosity Determination

USP Cysteine Hydrochloride – Assay and Loss on Drying

Specific Gravity of Liquids

Package Seal Dye Penetration for Glass Vials

Determination of Extractable Elements by Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES) Full Scan

Protein Analysis, in Support of Cleaning Studies

Hemoglobin Analysis, in support of cleaning studies

Carbohydrate Analysis, in support of cleaning studies

Automated Washer/ Disinfector Cycle for validation of processing/ reprocess of medical devices

21CFR177.1520 polypropylene or polymethylpentene

21CFR177.1520 polyethylene

Transportation Simulation Testing

Soiling and Manual Cleaning of Medical Devices

Soiling and Automated Cleaning of Medical Devices

Extraction of Medical Devices for Cleaning Studies

Cycles performed in the automated washer/disinfector

USP/NF Monograph Testing – Potentiometric Titration


Total Viable Spore Count

Anion and Cation analysis by Ion Chromatography

EO Survival/Kill Time Verification

Dry Heat Survival/Kill Time Verification

Steam Sterilization

Digestion of Samples for ICP

Spore Stain


Identification of Microorganisms – Aerobic Bacteria/Yeast

USP Safety Study

Maximization Sensitization Study – Japanese MHLW

ISO Closed Patch Sensitization Study

ISO Maximization Sensitization Study

USP Acute Toxicity Study

Systemic Toxicity Study – Japanese MHLW

ISO Acute Systemic Toxicity Study – Extract

Systemic Toxicity Study – Solution

FHSA Dermal Toxicity Study

FHSA Oral Toxicity Study

Oral Toxicity Study

USP Systemic Toxicity Study – Extract

ISO Vaginal Irritation Study

Demineralized Bone PrepaSubjection

Osteoinduction Activity – C2C12 Cell Culturing

Protein Concentration Determ. – Bicinchoninic Acid (BCA) Kit

Alkaline Phosphatase Activity Determ. – ALP Assay Kit

Chronic Systemic Toxicity Study in Subjects Following Implant

Systemic Toxicity Study – Repeated Parenteral Subjection

Absorption Capacity Testing for Chemistry

pH Determination

USP Physicochemical Tests for Plastics (Aqueous), Complete

Physicochemical Tests for Elastomeric Closures, Complete

Ethylene Glycol Analysis

Infrared Analysis

Particulate Analysis

Gas Chromatography

High Performance Liquid Chromatography (HPLC)

ASTM D2240 Durometer Hardness

Ultraviolet/Visible Scan

Ethylene Oxide Analysis

Melting Point Determination

Refractive Index Determination

Specific Gravity

Karl Fischer Method for Determination of Water Content

Aging/Thermal Conditioning – Program Schedule

USP Sterile Purified Water – Chemical Analysis

Vacuum Leak Test

JP Monograph Testing

Osmolarity/Osmolality Determination

Burst and Creep Package Evaluation Tests

Instron Testing of Materials

EP Monograph Testing

ASTM Condom Testing

Total Extractables in Repeated Use Rubber Articles

USP/NF Monograph Testing

USP Purified Water Testing – Total Organic Carbon

Package Seal Dye Penetration

JP Test Methods for Plastic Containers

Cytotoxicity Study Using the MEM Elution Method

Cytotoxicity Study Using the End-Point Method

Cytotoxicity Study Using the Agarose Overlay Method

Cytotoxicity Study Using the USP Agar Diffusion Method

Cytotoxicity Study Using the USP Elution Method

Cytotoxicity Study Using the ISO Elution Method

Cytotoxicity Study Using the ISO Agarose Overlay Method

Cytotoxicity Study – ISO Direct Contact Method

Genotoxicity, Mouse Peripheral Blood Micronucleus Study

Genotoxicity – Chromosomal Aberation / Mammalian Cells

Genotoxicity – Bacterial Reverse Mutation Study

Genotoxicity – Mouse Lymphoma Assay

Thrombo-resistance Study

C3a Complement Activation Assay

ASTM Hemolysis

ASTM Partial Thromboplastin Time

SC5b-9 Complement Activation Assay

Histopathology – Multiple Services Offered

USP Iron Dextran Absorption Study

Muscle Implantation Study, Japanese MHLW

ISO Subcutaneous Implantation Study

ISO Muscle Implantation Study

EP Pyrogen Study

JP Pyrogen Study

Intracutaneous Study – Japanese MHLW

FHSA Skin Irritation Study

MTT Cytotoxicity Study

FHSA Ocular Irritation Study

Urinary Bladder Irritation Study

Oral Mucosal Irritation Study – Collar Method

ISO Intracutaneous Study

ISO Ocular Irritation Study

ISO Contact Lens/Solution Ocular Irritation Study

ISO Penile Irritation Study

ISO Skin Irritation Study

USP Intracutaneous Study

In Vitro Irritation Assay

MHLW Pyrogen Study, Material Mediated

USP Pyrogen Study

Intraocular Irritation Study