— Biocompatibility Strategy Navigator —

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Analytical Services

Consulting Services

Chemical / Physical Characterization – Information

Test/Series ID: BA002

developed to help you navigate & Simplify the maze of global biological testing requirements

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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 – Repetitive

Zone of Inhibition

Environmental Monitoring of Viable Organisms

Filter Effectiveness Study (HIMA)

AATCC Test Method 30, Part III

Bioburden Recovery Validation – Inoculative

AATCC Test Method 100

Identification of Fungi Using an Automated Biochemical System

Kirby-Bauer Susceptibility Test

Sterility Dose Set

Preservative Effectiveness Test USP

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

Sterilization – EO Conventional Chamber

Bacteriostasis / Fungistasis

Alkaline Phosphatase Activity

Sterility-Inoculated Product

AATCC Test Method 147

AATCC Test Method 174 Part I

AATCC Test Method 174, Part II

USP Growth Promotion

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

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

In Vivo Osteoinduction Assay

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

Sterility-in situ-Product

Sterility Positive Investigation Report

Sterility-Direct Transfer Method

AATCC Test Method 174, Part III

Antimicrobial Evaluation Pink Stain Test

USP <1227>

USP <55> Total Viable Spore Count

ASTM E2149 Test Method

DNA Microbial ID with MicroSEQ

Sterility – Membrane Filtration

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

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

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

USP <671>, Containers, Light Transmission

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