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Medical Devices (11)
Biocompatibility & Toxicology (11)
Cytotoxicity
Genotoxicity
Hemocompatibility
Implantation with Histopathology Tests
Irritation
ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathway Devices
Physicochemical USP Plastics Tests
Risk Assessments
Sensitization
Subacute & Subchronic Toxicity
Systemic Toxicity Test
Extractables & Leachables for Medical Devices (Chemical Characterization) (2)
Material Characterization Screens of Raw Materials
Physicochemical USP Plastics Tests
Facility & Process Validation (8)
Disinfection Efficacy Studies
Environmental Monitoring Supplies – Air & Water
Environmental Monitoring Tests – Air & Water
Filter Sterilization Validations
Forced Degradation
Material Characterization Screens of Raw Materials
Residual Manufacturing Materials
Water System Validations & Monitoring
General Considerations
Method Development
Packaging Solutions (7)
Accelerated & Real-Time Aging
Container Closure Integrity – Dye Immersion & Bacterial Immersion
Container Closure Integrity – Mass Extraction
Microbial Aerosol Fallout Challenge Test
Packaging Integrity & Strength Test
Packaging Shelf Life Studies
Transportation and Distribution Performance
Personal Protective Equipment (PPE) Reprocessing
Protective Barriers & Material Performance (15)
Antimicrobial Efficacy Studies
Bacterial & Viral Filtration Efficiency (BFE/VFE)
Barrier Face Coverings Test
Flammability Test
Glove Testing
Hydrostatic Pressure Test
Microbial Cleanliness for Face Masks
Particle Filtration Efficiency (PFE)
Respirator Pre-Submission Tests – NIOSH
Spray Impact
Surgical Face Masks and General-Use Masks – ASTM F2100 & EN 14683
Surgical Gowns and Drapes – AAMI PB70 & EN 13795
Synthetic Blood Penetration for Liquid Barriers
Tensile and Tear Resistance Tests for Fabrics
Viral Penetration Test
Reuse Medical Device Processing (6)
Cleaning Validation – Reusable Devices
Disinfection Validation for Reusable Devices
Flexible Endoscope Sampling Kit
Functionality Testing
Scope Processing Validations – Reuse Device
Sterilization Validation – Reuse Device
Sterility Assurance (16)
Antibiotic Potency Test
Antimicrobial Preservative Effectiveness
Bacterial Endotoxins Test
Biological Indicator – Population Verification
Biological Indicator – Sterility Testing
EO Sterilant Residual Tests
Impurities Identification
Method Suitability (Bacteriostasis/Fungistasis)
Microbial Identifications
Particulate Matter
Product Bioburden – Medical Device
Product Sterility – Cleanroom
Product Sterility – Isolator
Radiation Quarterly Dose Audits (QDAs)
Standard Plate Counts
Tissue Testing Services
Sterilization Validations (11)
Clinical Batch Release
Contract Sterilization – Sterigenics
D-Value Determination Studies
Filter Sterilization Validations
Product Inoculations
Sterilization Exposure Cycles
Sterilization Relative Resistance
Sterilization Supplies (BIs, PCDs, & TestPacks)
Sterilization Validation – Ethylene Oxide (EO)
Sterilization Validation – Radiation
Sterilization Validation – Reuse Device
Pharmaceutical (10)
Biocompatibility & Toxicology (5)
Cytotoxicity
Genotoxicity
Physicochemical USP Plastics Tests
Risk Assessments
Systemic Toxicity Test
Chemistry Testing (5)
Compendial Testing
Dissolution Testing
Drug Assay (Active Ingredients and Dosage Forms)
Excipient Testing
Wet Chemistry Capabilities
Extractables & Leachables for Pharmaceuticals (10)
Compounds Screener Database
Inhalables OINDP
Injectables & Parenterals
Label Migration Studies
Liquid Oral Dosage Forms
Manufacturing Systems
Material Characterization Screens of Raw Materials
Ophthalmics
Physicochemical USP Plastics Tests
Topical Dosage Forms
Facility & Process Validation (8)
Disinfection Efficacy Studies
Environmental Monitoring Supplies – Air & Water
Environmental Monitoring Tests – Air & Water
Filter Sterilization Validations
Forced Degradation
Water System Validations & Monitoring
Water Testing
Wet Chemistry Capabilities
General Considerations
Impurities in Drug Components & API
Method Development
Packaging Solutions (9)
Accelerated & Real-Time Aging
Container Closure Integrity – Dye Immersion & Bacterial Immersion
Container Closure Integrity – Mass Extraction
Microbial Aerosol Fallout Challenge Test
Packaging Integrity & Strength Test
Packaging Shelf Life Studies
Stability Studies – Pharmaceutical
Transportation and Distribution Performance
Wet Chemistry Capabilities
Sterility Assurance (14)
Antibiotic Potency Test
Antimicrobial Preservative Effectiveness
Bacterial Endotoxins Test
Impurities Identification
Method Suitability (Bacteriostasis/Fungistasis)
Microbial Identifications
Microbiological Examination of Nonsterile Products
Mycoplasma Testing – PCR & Traditional
Particulate Matter
Product Sterility – Cleanroom
Product Sterility – Isolator
Radiation Quarterly Dose Audits (QDAs)
Virus and Virucidal Testing
Zone of Inhibition
Sterilization Validations (2)
Contract Sterilization – Sterigenics
Filter Sterilization Validations
Tissue Testing (4)
Facility & Process Validation (4)
Disinfection Efficacy Studies
Environmental Monitoring Supplies – Air & Water
Environmental Monitoring Tests – Air & Water
Water System Validations & Monitoring
Packaging Solutions (3)
Accelerated & Real-Time Aging
Packaging Integrity & Strength Test
Packaging Shelf Life Studies
Sterility Assurance (5)
Microbial Identifications
Product Sterility – Cleanroom
Radiation Quarterly Dose Audits (QDAs)
Standard Plate Counts
Tissue Testing Services
Sterilization Validations (4)
Contract Sterilization – Sterigenics
D-Value Determination Studies
Product Inoculations
Sterilization Validation – Radiation
Medical Devices (11)
Biocompatibility & Toxicology (11)
Cytotoxicity
Genotoxicity
Hemocompatibility
Implantation with Histopathology Tests
Irritation
ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathway Devices
Physicochemical USP Plastics Tests
Risk Assessments
Sensitization
Subacute & Subchronic Toxicity
Systemic Toxicity Test
Extractables & Leachables for Medical Devices (Chemical Characterization) (2)
Material Characterization Screens of Raw Materials
Physicochemical USP Plastics Tests
Facility & Process Validation (8)
Disinfection Efficacy Studies
Environmental Monitoring Supplies – Air & Water
Environmental Monitoring Tests – Air & Water
Filter Sterilization Validations
Forced Degradation
Material Characterization Screens of Raw Materials
Residual Manufacturing Materials
Water System Validations & Monitoring
General Considerations
Method Development
Packaging Solutions (7)
Accelerated & Real-Time Aging
Container Closure Integrity – Dye Immersion & Bacterial Immersion
Container Closure Integrity – Mass Extraction
Microbial Aerosol Fallout Challenge Test
Packaging Integrity & Strength Test
Packaging Shelf Life Studies
Transportation and Distribution Performance
Personal Protective Equipment (PPE) Reprocessing
Protective Barriers & Material Performance (15)
Antimicrobial Efficacy Studies
Bacterial & Viral Filtration Efficiency (BFE/VFE)
Barrier Face Coverings Test
Flammability Test
Glove Testing
Hydrostatic Pressure Test
Microbial Cleanliness for Face Masks
Particle Filtration Efficiency (PFE)
Respirator Pre-Submission Tests – NIOSH
Spray Impact
Surgical Face Masks and General-Use Masks – ASTM F2100 & EN 14683
Surgical Gowns and Drapes – AAMI PB70 & EN 13795
Synthetic Blood Penetration for Liquid Barriers
Tensile and Tear Resistance Tests for Fabrics
Viral Penetration Test
Reuse Medical Device Processing (6)
Cleaning Validation – Reusable Devices
Disinfection Validation for Reusable Devices
Flexible Endoscope Sampling Kit
Functionality Testing
Scope Processing Validations – Reuse Device
Sterilization Validation – Reuse Device
Sterility Assurance (16)
Antibiotic Potency Test
Antimicrobial Preservative Effectiveness
Bacterial Endotoxins Test
Biological Indicator – Population Verification
Biological Indicator – Sterility Testing
EO Sterilant Residual Tests
Impurities Identification
Method Suitability (Bacteriostasis/Fungistasis)
Microbial Identifications
Particulate Matter
Product Bioburden – Medical Device
Product Sterility – Cleanroom
Product Sterility – Isolator
Radiation Quarterly Dose Audits (QDAs)
Standard Plate Counts
Tissue Testing Services
Sterilization Validations (11)
Clinical Batch Release
Contract Sterilization – Sterigenics
D-Value Determination Studies
Filter Sterilization Validations
Product Inoculations
Sterilization Exposure Cycles
Sterilization Relative Resistance
Sterilization Supplies (BIs, PCDs, & TestPacks)
Sterilization Validation – Ethylene Oxide (EO)
Sterilization Validation – Radiation
Sterilization Validation – Reuse Device
Pharmaceutical (10)
Biocompatibility & Toxicology (5)
Cytotoxicity
Genotoxicity
Physicochemical USP Plastics Tests
Risk Assessments
Systemic Toxicity Test
Chemistry Testing (5)
Compendial Testing
Dissolution Testing
Drug Assay (Active Ingredients and Dosage Forms)
Excipient Testing
Wet Chemistry Capabilities
Extractables & Leachables for Pharmaceuticals (10)
Compounds Screener Database
Inhalables OINDP
Injectables & Parenterals
Label Migration Studies
Liquid Oral Dosage Forms
Manufacturing Systems
Material Characterization Screens of Raw Materials
Ophthalmics
Physicochemical USP Plastics Tests
Topical Dosage Forms
Facility & Process Validation (8)
Disinfection Efficacy Studies
Environmental Monitoring Supplies – Air & Water
Environmental Monitoring Tests – Air & Water
Filter Sterilization Validations
Forced Degradation
Water System Validations & Monitoring
Water Testing
Wet Chemistry Capabilities
General Considerations
Impurities in Drug Components & API
Method Development
Packaging Solutions (9)
Accelerated & Real-Time Aging
Container Closure Integrity – Dye Immersion & Bacterial Immersion
Container Closure Integrity – Mass Extraction
Microbial Aerosol Fallout Challenge Test
Packaging Integrity & Strength Test
Packaging Shelf Life Studies
Stability Studies – Pharmaceutical
Transportation and Distribution Performance
Wet Chemistry Capabilities
Sterility Assurance (14)
Antibiotic Potency Test
Antimicrobial Preservative Effectiveness
Bacterial Endotoxins Test
Impurities Identification
Method Suitability (Bacteriostasis/Fungistasis)
Microbial Identifications
Microbiological Examination of Nonsterile Products
Mycoplasma Testing – PCR & Traditional
Particulate Matter
Product Sterility – Cleanroom
Product Sterility – Isolator
Radiation Quarterly Dose Audits (QDAs)
Virus and Virucidal Testing
Zone of Inhibition
Sterilization Validations (2)
Contract Sterilization – Sterigenics
Filter Sterilization Validations
Tissue Testing (4)
Facility & Process Validation (4)
Disinfection Efficacy Studies
Environmental Monitoring Supplies – Air & Water
Environmental Monitoring Tests – Air & Water
Water System Validations & Monitoring
Packaging Solutions (3)
Accelerated & Real-Time Aging
Packaging Integrity & Strength Test
Packaging Shelf Life Studies
Sterility Assurance (5)
Microbial Identifications
Product Sterility – Cleanroom
Radiation Quarterly Dose Audits (QDAs)
Standard Plate Counts
Tissue Testing Services
Sterilization Validations (4)
Contract Sterilization – Sterigenics
D-Value Determination Studies
Product Inoculations
Sterilization Validation – Radiation
Radiation Quarterly Dose Audits (QDAs)
Information about radiation QDAs is included in the
Sterilization Validations – Radiation
section.
Testing Locations
Salt Lake City, UT, USA
Itasca, IL, USA
Fairfield, NJ, USA
Ontario, CA, USA
Mexico City, Mexico
Petit-Rechain, Belgium
Somercotes, England
Rantigny, France
Testing
Find a Test
Get a Quote
Submit a Sample
MDR
Advisory Services
Ask Our Experts
Testing Advisory
Regulatory & Quality Advisory
Meet Our Experts
Request a Quote
Request a Quote
Re-Order Quotes
Education
Education Overview
Blog
Brochures
On-Demand Webinars
Published Articles
Video Gallery
Whitepapers
Sotera Health Academy
News & Events
News
Seminars
Trade Shows
Upcoming Live Webinars
Coronavirus Updates
About Us
Our Company
Coronavirus Updates
Careers USA
Careers Europe
Codes of Conduct
Contact Us
Partners
Quality
Regulatory Resources
Service Terms
Global Locations
Lab Testing
Regulatory Compliance & Quality Control
Sotera Health Academy
Pay Bill
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