1-763-639-7111 | info@microbioconsulting.com
PO BOX 123, Chisago City, MN 55013

Our Services
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:
Microbiology
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Bioburden Evaluation
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Endotoxin Evaluation
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Microbiological Investigations
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Cleanroom and Controlled Environments
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Lab Design
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Equipment IQ/OQ/PQ
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Test Method Validation
Sterilization
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Sterilization Validation
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Ethylene Oxide (EO)
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Gamma Irradiation
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E-Beam Irradiation
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Steam/Autoclave
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Vaporized Hydrogen Peroxide (VHP)
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Vaporized Peracetic Acid (VPA) & Peracetic Acid (PPA)
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Nitrogen Dioxide
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Reprocessing
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Cleaning
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Low-Level Disinfection
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High-Level Disinfection
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Reusable Device Sterilization Validation
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Test Method Validation
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Instructions for Use (IFU)
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Performance/Functionality Evaluations
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Material Compatibility
Biocompatibility
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Biological Safety Evaluations
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Biocompatibility Risk Assessments
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Biocompatibility Plans, Protocols, Reports
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Gap Assessments
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EU MDR Remediation
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Material Biocompatibility
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Rationale/Justification
Chemistry

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Chemical Characterization
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Extractables and Leachables
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Testing Strategies
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Targeted Compound Quantification
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Assessment of Identified/Quantified Chemical Compounds
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Drug Stability/Compatibility Assessments
Toxicology

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Toxicological Risk Assessments
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Hazard Characterization of Chemical Compounds
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Risk Characterization of Chemical Compounds
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Restricted Substances (REACH, RoHS, California Proposition 65, etc.)
Industries
Medical Device
Pharmaceuticals
In-Vitro Diagnostics
Biologics
Nanotechnology
Forensics
Lab Consumables
Sterilants
Nucleic Acids & Proteins
Sterilizers

Tattoo Ink
Food/Beverage
Packaging
Hemp/Cannabis
Personal Protective Equipment

