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Whether it's reviewing existing data, performing a gap assessment, supporting an audit or CAPA, ensuring compliance to EU MDR or developing new testing strategies, we will provide the support your project needs.

MicroBio Consulting's technical expertise includes the following subject areas:

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Microbiology

  • Bioburden Evaluation

  • Endotoxin Evaluation

  • Microbiological Investigations

  • Cleanroom and Controlled Environments

  • Lab Design

  • Equipment IQ/OQ/PQ

  • Test Method Validation

Sterilization

  • Sterilization Validation

    • Ethylene Oxide (EO)​

    • Gamma Irradiation

    • E-Beam Irradiation

    • Steam/Autoclave

    • Vaporized Hydrogen Peroxide (VHP)

    • Vaporized Peracetic Acid (VPA) & Peracetic Acid (PPA)

    • Nitrogen Dioxide

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Reprocessing

  • Cleaning

  • Low-Level Disinfection

  • High-Level Disinfection

  • Reusable Device Sterilization Validation

  • Test Method Validation

  • Instructions for Use (IFU)

  • Performance/Functionality Evaluations

  • Material Compatibility

Biocompatibility

  • Biological Safety Evaluations

  • Biocompatibility Risk Assessments

  • Biocompatibility Plans, Protocols, Reports

  • Gap Assessments

  • EU MDR Remediation

  • Material Biocompatibility

  • Rationale/Justification

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Chemistry

  • Chemical Characterization

  • Extractables and Leachables

  • Testing Strategies

  • Targeted Compound  Quantification

  • Assessment of Identified/Quantified Chemical Compounds

  • Drug Stability/Compatibility Assessments

Toxicology

  • Toxicological Risk Assessments

  • Hazard Characterization of Chemical Compounds

  • Risk Characterization of Chemical Compounds

  • Restricted Substances (REACH, RoHS, California Proposition 65, etc.)

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Industries

Medical Device
Pharmaceuticals
In-Vitro Diagnostics
Biologics
Nanotechnology 
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Lab Consumables
Forensics
Nucleic Acids & Proteins
Sterilizers
Sterilants
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Tattoo Ink
Food/Beverage
Packaging
Hemp/Cannabis
Personal Protective Equipment
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Cleanrooms/ Controlled Environments
Veterinary Products
Lab Equipment
Lab Design
Cosmetics
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Vegan Products
Microbiome Products
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