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Testing
- Accelerated & Real-Time Aging
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- Antibiotic Potency Test
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- Bacterial & Viral Filtration Efficiency (BFE/VFE)
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- Biological Indicator – Population Verification
- Biological Indicator – Sterility Testing
- Cleaning Validation – Reusable Devices
- Clinical Batch Release
- Compendial Testing
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- Container Closure Integrity – Dye Immersion & Bacterial Immersion
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- Cytotoxicity
- D-Value Determination Studies
- Disinfection Efficacy Studies
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- Dissolution Testing
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- Environmental Monitoring Supplies
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- EO Sterilant Residual Tests
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- Functionality Testing
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- Hemocompatibility
- Hydrostatic Pressure Test
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- Impurities Identification
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- Irritation
- ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathway Devices
- Label Migration Studies
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- Material Characterization Screens of Raw Materials
- Method Development
- Method Suitability (Bacteriostasis/Fungistasis)
- Microbial Aerosol Fallout Challenge Test
- Microbial Cleanliness for Face Masks
- Microbial Identifications
- Microbiological Examination of Nonsterile Products
- Mouse Lymphoma Testing
- Mycoplasma Testing – PCR & Traditional
- Ophthalmics
- Packaging Integrity & Strength Test
- Packaging Shelf Life Studies
- Particle Filtration Efficiency (PFE)
- Particulate Matter
- Physicochemical USP Plastics Tests
- Product Bioburden – Medical Device
- Product Inoculations
- Product Sterility – Cleanroom
- Product Sterility – Isolator
- Radiation Quarterly Dose Audits (QDAs)
- Residual Manufacturing Materials
- Respirator Pre-Submission Tests – NIOSH
- Risk Assessments
- Scope Processing Validations – Reuse Device
- Sensitization
- Spray Impact
- Stability Studies – Pharmaceutical
- Standard Plate Counts
- Sterilization Exposure Cycles
- Sterilization Relative Resistance
- Sterilization Supplies (BIs, PCDs, & TestPacks)
- Sterilization Validation – Ethylene Oxide (EO)
- Sterilization Validation – Radiation
- Sterilization Validation – Reuse Device
- Subacute & Subchronic Toxicity
- 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
- Systemic Toxicity Test
- Tensile and Tear Resistance Tests for Fabrics
- Tissue Testing Services
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- Zone of Inhibition
Expert Bio
- Alpa Patel
- Anja Cerstiaens
- Annick Gillet
- Audrey Turley
- Bryce Telford
- Dennis Jenke
- Dries Cardoen
- Elizabeth Tiseo
- Frank De Smedt
- Gregory Grams
- Griffin Cammack
- Helin Räägel
- Janelle ‘Jeni’ Lauer
- Jennifer Gygi
- Karen Pieters
- Lise Vanderkelen
- Martell Winters
- Nancy Vanderlinden
- Nicole Palluck
- Piet Christiaens
- Sarah Campbell
- Shiri Hechter
- Terri Eastman
- Thor Rollins
Events
- 2022 State of the Medical Device Industry: Quality, Biocompatibility, and Changing Regulations
- A delay in MDR? Where are we now?
- A Structured Approach to Selection of Container Closure Materials for Small Volume Parenterals – Pipe Dream or Necessity?
- A Year of MDR Remediation: Biocompatibility Strategies and Lessons Learned
- Addressing Common Observations in Regulatory Submissions of Chemical Characterization Results
- After E&L: Updates to the Standard for Toxicological Risk Assessment 10993-17
- An outline of current medical face mask performance requirements and testing
- Analytical Approaches used in E&L studies from Basic Instrumentation to High-End, State-of-the Art Equipment to Support Structural Elucidation
- Appropriate Uses for Product Sterility Testing: When Is Sterility Testing Appropriate?
- Assessing the Safety of Extractables & Leachables for Drug Products
- Bacterial Endotoxin Testing; History, Inhibition/Enhancement, & Process Control
- Becoming Compliant with the MDRs, A Real Life Case Study
- Best Practices When Validating Reusable Devices
- Big Changes to ISO 10993-1: What Is Happening to the Main Biocompatibility Standard Now?
- Bioburden Alert and Action Levels – Low hanging fruit for a FDA Citation
- Bioburden Testing and Microorganism Characterization: Enhanced Guidance for Low-Sterilization-Dose Products
- Biocompatibility and the New MDR
- Biocompatibility Evaluation for Device Submission
- Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial
- Biocompatibility of Raw Materials for Medical Devices
- Biocompatibility: Applying the New ISO 10993 Standards
- BIOMEDevice Boston 2023
- BIOMEDevice Silicon Valley 2023
- Calling Attention to Burkholderia spp. and Mitigating Risk Through a Robust Preservative System
- Categorizing Medical Devices Per ISO 10993-1
- Challenges and Best Practices for Extractables and Leachables in Ophthalmic Drug Products
- Changes to ISO10993-1 and relationship to Medical Device Regulation
- Changing a colorant in an approved medical device, what should I know?
- Changing Expectations with Endoscope Reprocessing
- Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
- Chemical Characterization and Toxicological Risk Assessment for Medical Device Biocompatibility
- Chemical characterization on a combination device form Biological Evaluation Plan to practice
- Cleaning Evaluations of Newly Manufactured Devices
- Cleaning Validations for Newly Manufactured Medical Devices and Single Use Implants
- Cleaning validations for reusable devices
- Cleaning, Disinfection and Sterilization of Medical Devices: Updates to Reprocessing Guidance Documents AAMI TIR 12 and TIR30 (ST98)
- Considerations for Third-Party Reprocessing of Single-Use Medical Devices
- Container Closure Integrity and Stability Testing for Rigid Containers
- Contamination Control For Pharmaceutical Products: Real-World Moist-Heat-Validation Pitfalls And Proper Verification of Sterility
- Controlling Endotoxin Contamination During Pharmaceutical Production
- COVID-19, what we learned from the race to supply the market with respirators, masks, and other PPE
- Cytotoxic Reactivity: Understanding the Cause and the Path Forward
- Day 1: Assessing Biocompatibility for Medical Devices: Updates, Trends, and Anticipated Changes
- Day 1: Develop a Biological Evaluation Plan (BEP)
- DAY 1: Validating, Optimizing and Monitoring EO Sterilization Processes
- Day 2: Understanding Test Options
- DAY 2: Validating, Optimizing and Monitoring EO Sterilization Processes
- Day 3: Summarize all your findings in a Biological Evaluation Report (BER): The ISO 10993-1
- Decontamination, Sterile Processing, and Performance Testing of Personal Protective Equipment (PPE)
- Design Change Impact on Biocompatibility and Documentation
- Designing an End-to-End Sterility Assurance Program
- Developing a Biological Safety Evaluation
- Developing a Test Strategy and Plan
- Developing your Packaging Validation Plan
- Discussion of Feedback Received Directly from FDA on ChemTox
- Disinfectant Efficacy Testing Study Design and Data Interpretation for the U.S. Environmental Protection Agency
- Disinfectant-Efficacy Testing – Coupon/Carrier Method
- Disinfection Validations for Reusable Devices
- EPA Regulatory and Testing Guidelines for Residual Efficacy: How to Make Antimicrobial Product Claims
- Essential Principles of Chemical Characterization (Extractables and Leachables) Applied to Small Volume Parenterals (SVPs)
- Ethylene Oxide – Navigating Recent Standards Changes and Industry Challenges
- Ethylene Oxide Sterilization Validation
- Ethylene Oxide Sterilization- Batch Release Method
- Ethylene Oxide Sterilization, Revision of Annex E, Single Batch Release
- EU MDR & IVDR True Quality Summit
- EVALUATING NEED FOR BIOCOMPATIBILITY TESTING & MITIGATING RISKS WHEN CHANGING YOUR MEDICAL DEVICE
- Evaluating Persistent or Residual Antimicrobial Efficacy of Topically Applied Products in a Clinical Trial
- Extractables & Leachables Testing of Single-Use Systems for Production
- Extractables and leachables testing of a combination device: testing in between regulations for pharmaceutical products and medical devices
- Face Masks and Respirators
- FDA Regulation of Hand Sanitizers: What Testing Should be Conducted to Market a New Hand Sanitizer?
- Filter Sterilization Validations
- Focus on Fundamentals: Biocompatibility/Biosafety
- Focus on Fundamentals: Ethylene Oxide and Radiation Sterilization
- Focus on Fundamentals: Packaging
- Guidance for cleaning, disinfection and sterilization of reusable medical devices
- Guidance for Understanding Container Closure Integrity Test Failures
- How mass spectrometry can give you very good ID’s
- How to Address Regulatory Change in Your Current Biocompatibility Program
- How to select a CRO for Chemical Characterization Testing
- How to win the game: Evaluating the biocompatibility of reusable medical devices during their whole life cycle
- Hunt for N-nitrosamines in medicinal products
- ICH Stability Testing and Method Development
- Identifying & Mitigating Errors in Organic Extractables & Leachables Screening
- If Something Looks Clean, Is It Really Clean? Cleaning Validations for Reusable Devices
- Impact of Device Changes on Biocompatibility
- Impact of MDR on Biocompatibility, a Shortage of Expertise
- Introduction to Sotera Health
- Irritation Testing is Becoming Less Irritating
- Is It Time to Re-Evaluate Your Design History File (DHF)?
- ISO 10993-18 in the MDR: understanding the restrictions and risk assessment for compounds which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties (section 10.4)
- Itasca Open House 2023
- Key Elements of a Sterility Assurance Program
- Learning From HAIs: Understanding Reprocessing Regulations, Validation & Human Factors
- LVP polyolefin solutions addressing different packaging and regulatory requirements
- Manufacturing an SVP Drug Containment Solution: Quality by Design
- Mass Extraction: Container Closure “CCIT” for Rigid Containers
- MD&M East
- MD&M Minneapolis 2023
- MDR Effects on Medical Device Processing
- MDR Effects on Processing Devices
- MDR/IVDR – so you think your plastics supply chain can help? How MedPharmPlast is helping to overcome the potential challenges
- Medical Device Biofilms: Slimy, Sticky, Stubborn, and Serious
- Medical Device Testing Regulatory Updates, Trends and Changes including: FDA, ISO and MDR
- Meeting Requirement 10.4 of the MDR – How to Address CMRs?
- Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE)
- Microbiological Control in a Pharmaceutical Manufacturing Environment
- MPO Packaging Validations – A Look at Current and Future State Testing
- N-Nitrosamines in Primary Packaging for SVP’s
- Navigating Packaging Changes in Light of New Regulatory Requirements
- Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18
- New Approaches to Assessing Biocompatibility for Medical Devices
- New FDA Expectations for Endotoxin Testing
- New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016
- On the Origin of Extractable Species
- Overcoming a Cytotoxicity Failure
- Packaging Design Validation Testing
- Packaging Trends Leading to Increased 483’s
- Packaging validation 101
- Packaging Validation 101, Part 2 (Process Validation)
- Packaging Validations: The Current and Future State of Testing
- Packaging: Design for Sterilization
- PDA SoCal Chapter: 12th Annual Industry Summit Showcase Vendor Night
- Pharma Packaging Considerations for Radiation Processing
- Polymer-based, Pre-filled Syringes designed to Minimize the Aggregation Risk of Sensitive Biodrugs
- Primary and Secondary Packaging Materials as potential source of Nitrosamines: impact on E&L Study design
- Primary Packaging Considerations from a Biologics Product Development Perspective
- Radiation Sterilization of SVPP: RTU and fill/finished. Do not default to 25 kGy – 40 kGy
- Reactive Leachables
- Reactive Leachables: Chemical Interaction between Leachables and Insulin / Therapeutic Proteins
- Recent FDA biocompatibility feedback from 510k submissions
- Recent FDA feedback regarding extractable and leachable testing and how to make sure FDA will accept your testing protocol
- Regulatory Requirements for Packaging Changes
- Release & Stability Testing Requirements for Parenteral Drug Products
- Removing Rabbits from Irritation Testing: Regulatory Acceptance of ISO 10993-23
- Reprocessing Validations of Reusable Medical Devices
- Reprocessing Validations: Cleaning Validation
- Reprocessing Validations: Flexible Endoscopes and AAMI ST91
- Requirements and Impact of the New Guideline – ISO 10993-23: Tests for Irritation
- Risk Assessment for Potential Elemental Impurities on Drug Products/Medical Devices
- Risk Assessment for Single-Use Systems: USP 665 vs. BPOG
- Rubber Manufacturing and Composition of Pharma Rubbers
- Rubber Oligomers
- Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Health Care Application
- Setting up Extractables & Leachables Studies for Small Volume Parenteral Applications
- Shifting Requirements Within the FDA: Expectations in Chemistry Study Design
- Shortages of critical raw materials and managing changes and substitutions
- Skin-Care Products: Understanding Clinical Testing Options
- Slimy Biofilms: A Brief Overview
- Sterility, Manufacturing, and Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals
- Sterilization and Sterility Verification of Single-Use Systems
- Sterilization of Your Medical Device
- SVP Packaging – NB Persepective on CE-marked Medical Devices versus Article 117 MDR Combination Products
- Switching Sterilization: What Should You Consider When Changing Processes?
- Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces
- The Big Three: Cytotoxicity, Sensitization & Irritation Testing
- The biocompatibility-trail: a challenging hike towards an animal-free biological safety evaluation of your medical device
- The Biological Evaluation Plan (BEP): A crucial first step in the Biocompatibility evaluation of a Medical Device
- The Biological Evaluation Plan (BEP): A crucial first step in the biocompatibility evaluation of a medical device
- The Challenges in Tox Assessments for Small Volume Parenteral Packaging System Applications
- The Current Regulatory Acceptance of In Vitro Alternatives for Biocompatibility
- The Essence Of The EU MDR
- The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
- The Necessity of Extractables & Leachables Qualifications for Lyophilized Drug Products
- The Necessity of Extractables and Leachables Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.
- The need to Identify “Unknowns” from a Risk Management Perspective
- The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice List
- The new ISO 10993 – 18 Standard and its Impact on Chemical Characterization of Medical Devices
- The Testing & Risk Management Impacts of Changing a Medical Device
- The Validation of Sterile Medical Devices 2023 Barcelona
- The Validation of Sterile Medical Devices Chicago
- The Validation of Sterile Medical Devices San Jose
- Thermal Disinfection & Steam Sterilization Validation for Reusable Devices
- Transportation and Distribution Testing for Medical Devices
- Understanding Ethylene Oxide Sterilization
- Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting
- Upcoming Changes to Cleaning Validations for Reusable Medical Devices
- Updates & Trends from FDA; Including Recent ISO 10993 News
- US Drug Delivery Combination Product Regulatory
- Video: An introduction to large volume parenterals (LVPs) as a pharmaceutical dosage form and an E&L challenge
- Video: Blow-fill-seal technology in large volume parenteral packaging
- Video: Challenges and considerations for complex LVP drug products
- Video: Notified body perspective on CE-marked medical devices versus article 117 MDR combination products
- Video: Testing of the drug product, stored in a large volume parenteral packaging system: Leachable study design and challenges
- Video: Testing of the packaging: Extractable study design and challenges
- Video: The challenges in tox assessments for large volume parenteral packaging system applications
- Video: The design and qualification process for a LVP packaging system from a user perspective; case study nitrosamines
- Video: The need for high-end analytical technology to support the need for a higher level of identifications in large volume parenteral packaging qualifications
- Video: The production process and qualification of film: A film manufacturer perspective
- Video: The value of simulation studies for LVP packaging systems
- Video: Use of auxiliary information to support the development and qualification of flexible LVP packaging
- Virucidal-Efficacy Testing for Submission to Regulatory Agencies
- What is Changing in the Global Regulatory Landscape
- What is Design Control and how does it apply to Nelson Labs?
- When Do I Really Need to Perform an Ethylene Oxide Requalification?
- When drug meets device: How to assess compatibility?
- When Playing with Drugs and Devices, How do you Win the “Combined Product” Game?
- Why is the sterility of your drug product much more than just a test of sterility?
Video Gallery
- A 2013 ISO 10993 Update on Biocompatibility
- Becoming Compliant with the MDR, A Real Life Case Study
- Biocompatibility Standard Changes: Is Your Testing Up to Date?
- Biocompatibility Testing and Evaluations: Meeting Target Deadlines in a Highly Constrained Environment
- Celebrating 30 Years Of Life-Saving Innovation
- Chemical Characterization According to ISO 10993-18
- Chemical Characterization for Medical Devices: The Basics
- Chemical Characterization: How to Prepare for the Future in This Time of Transition
- Cleaning Validation Roadmap for Reusable Medical Devices
- Cleaning Validations for Reusable Medical Devices
- Current Innovations with Radiation Sterilization
- D-value: Biological Indicator Resistance Testing
- Developing biocompatibility for medical devices: incorporating E&L, ISO, FDA, and MDR requirements
- Establish a Baseline ID to Save Time and Costs
- Ethylene Oxide Sterilization of Small or Infrequent Lots: Batch Release Method
- Ethylene Oxide Sterilization Validations
- Extractable and Leachable Chemistry Testing: How to Prepare for the Future
- FDA Trends Impacting Hemocompatibility & Genotoxicity Testing including an ISO 10993 Update
- FDA Trends with Reusable Medical Devices
- Gown and Drape Barrier Testing
- Health Care Reprocessing of Medical Devices and Human Factors Debrief
- How the new FDA guidance ‘Use of International Standard ISO 10993-1′ affects you and your medical device
- How To Address Device And Regulatory Change From A Biocompatibility Perspective
- How to Categorize a Medical Device per ISO 10993-1
- How to Use Biocompatibility to Evaluate Changes in a Medical Device
- Jeffery R. Nelson Explains: “Who is Nelson Labs?”
- Key Factors that Determine a Successful Reusable Medical Device Cleaning Validation
- MD&M East Tech Theater: The Future of Biocompatibility Industry Trends and Hurdles
- MDM West Tech Theater: New FDA Guidance on ISO 10993-1 and How it Affects You
- Medical Device Packaging Validations
- Modernizing the Aseptic Process
- Nelson Laboratories
- Nelson Labs Europe Video
- New Approaches to Assessing Biocompatibility for Medical Devices
- New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety
- New Trends in Cleaning and Disinfection Validations for Reusable Devices
- Overcoming a Cytotoxicity Failure
- Packaging Trends Leading to Increased 483’s
- Phil Triolo Testimonial of Nelson Laboratories
- Present and Future Changes to Packaging Industry Standards
- Process Validations for Newly Manufactured Devices – Is Your New Device Clean?
- Radiation Sterilization Validations
- Regulatory and Revalidation Considerations for Packaging Materials
- Regulatory Requirements for Packaging Changes
- Routine BI Positive Failure Investigations
- Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways
- Strategies for Testing Hemocompatibility and Potential Upcoming Changes
- The Big Three: Cytotoxicity, Sensitization & Irritation Testing
- The Current State of Biocompatibility: How FDA & CE Are Looking at Biocompatibility
- The Future of 10993 and the Proposed ISO 10993 Changes for Hemocompatibility and Genotoxicity
- The Future of Biocompatibility Testing Might Just be Animal Free!
- The Future of Biocompatibility: Industry Trends and Hurdles
- The Journey of Revealing Unknowns and Impurities by Material
- The New “Big Three” Biocompatibility In Vitro Alternatives Are at Our Door
- The Power of Chemical Characterization to Assess Changes in Your Medical Device
- Updates to ISO 10993-1 and ISO 21726
- Updates to the Bioburden Standard ISO 11737-1; Significant Additional Guidance.
- Video Testimonial from John Lincoln about Nelson Labs
- What is Material Characterization and How to Use it to Supplement Your Safety Evaluations
- Whirlwind of Change: How New Standards, MDR, and Brexit are Impacting Biocompatibility
Posts
- 10 Things to Do at MD&M West 2020
- 2013 MedTech retrospective
- 2013 to Be a Big Year for Biocompatibility; Nelson Labs Participates in Potential Updates
- 2016 Year in Review
- 2017 Fall AAMI Sterilization Standards Meetings Update
- 2017 Mid-year Thought Leadership Update
- 2017 Spring AAMI Sterilization Standards Meeting Update
- 2018 Educational Resources
- 26th of May 2021, A Day Many Medical Device Manufacturers Will Never Forget…
- 3-D Medical Device Validation
- 3D Printed Devices and Biocompatibility
- 3D Printed Devices and Biocompatibility: Details of the Material Curing Process
- 3D Printed Devices and Biocompatibility: Material Aeration
- 3D Printed Devices and Biocompatibility: Post-Printing and Finishing
- 3D Printed Medical Devices and Biocompatibility Whitepaper
- 7 Things to Consider When Using a Medical Device Contract Packager
- A Brief Introduction to Medical Device Biocompatibility
- A Discourse on Pharmaceutical cGMP FDA Form 483 Trends: Why are We Re-Living the Same Issues Over the Last 23 Years?
- A General Overview of Requirements for Marketing Topically Applied Skin Antiseptics in the United States
- A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?
- A Stepwise Approach to Deal with In Vitro Cytotoxicity Failures
- A Test of Character: Using Chemical Characterization to Assess Patient Risk
- AAMI Sterilization Standards Meeting Update on Processing of Reusable Medical Devices
- AAMI Survey on the Use of and Experiences with Method VDmax
- Accelerated Aging Package Testing
- Addressing Personal Protective Equipment (PPE) Decontamination: Methylene Blue and Light Inactivates SARS-CoV-2 on N95 Respirators and Masks with Maintenance of Integrity and Fit
- Addressing personal protective equipment (PPE) decontamination: Methylene blue and light inactivates severe acute respiratory coronavirus virus 2 (SARS-CoV-2) on N95 respirators and medical masks with maintenance of integrity and fit
- Addressing the Ongoing Risks of C. Diff in Healthcare Settings
- Advances in in-vitro testing from the Society of Toxicology Meeting
- Aerosol Challenge Exposure: A Retrospective Review
- Alpa Patel Celebrated for Contributions to New Test Soils Standard
- Alternatives To In Vivo Biocompatibility Testing
- An Ingredient List for Your Medical Device?
- An Interview with Dr. Piet Christians – American Pharmaceutical Review
- Another Reason to Update Your Biocompatibility Approach: EU MDRs
- ANSI/AAMI PB70 Sample Size Requirements: Understanding Sampling Plans
- ANSI/AAMI PB70: Closing the Gap
- Application note: Why extractables and leachables matter
- Are You Ready for the New ANSI/AAMI Standard, ST98, Regarding How to Perform Cleaning Validations for Health-Care Products?
- Are you required to perform reprocessing validations for all your devices?
- Are Your Tissue Banking Processes Validated?
- Assessing Hemocompatibility for Medical Devices in Contact with Circulating Blood
- Assessing Nanoparticles for Biocompatibility
- ASTM Committee Meeting Updates for F02 and D10
- Avoid These Headaches During Regulatory Submissions
- Become Compliant with MDR as Soon as Possible
- Benefits of Premarket and Postmarket Particulate Testing of Cardiovascular Devices
- Biocompatibility Advancements To Be Showcased At MD&M Minneapolis ǀ Nelson Laboratories
- Biocompatibility Fundamentals for Medical Devices eBook
- Biological Indicator Resistance Testing
- Biological safety in the context of backward planetary protection and Mars Sample Return: conclusions from the Sterilization Working Group
- BIOMEDevice San Jose Focus On Biocompatibility
- Building Distribution Test Plans In Accordance to ASTM D4169
- Burden of Proof: An Orthopedic Testing & Analysis Roundtable
- Can manual cleaning and disinfection be combined into a one-step process?
- Can you randomly choose analytes to use as end-points for the cleaning validation of a reusable device?
- Candida Auris Surge: Highlighting the Importance of Surface Disinfection
- Celebrating Audrey Turley: 20 Years at Nelson Laboratories
- Challenging the Status Quo of Sterile Environments
- Changes Related to Cleaning Validations
- Chemical Characterization Has Come a Long Way
- Chemical Passivation Test Ensures Passivated Medical Devices Don’t Corrode
- Chemistry for Toxicological Risk Assessment—Transitions in Expected Approach
- Choosing Colorants for Medical Devices
- Cleanroom Renovation Complete
- Comments on “Reprocessing Guidance for Industry and FDA Staff,” issued March 17, 2015
- Complete EN 13795 Suite of Tests Offered by Nelson Laboratories
- Comprehensive Chemical Characterization of Extractables and Leachables (E&L) in Medical Devices with Mass Spectrometry
- Conduct Container Closure Integrity Testing Before Validation and Annually Thereafter
- Consider the Most Probable Number Method for Bioburden Testing
- Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices
- Considerations for Third-Party Reprocessing of Single-Use Medical Devices
- Container Closure Integrity Testing Through Mass Extraction
- Coronavirus & Barrier Material Tests
- Coronavirus & Barrier Material Tests
- Creative Proof
- Custom Packaging Typically Required for Orthopedic Devices
- Cytotoxicity Failure – What Now?
- Decontamination and Sterile Processing of Personal Protective Equipment
- Determining a Valid Sample Size for Package Testing
- DISINFECTION VALIDATION: How to Classify and Validate Your Medical Device Disinfection Process
- Does Your Non-patient Contacting Device or Surface Require a Cleaning and Disinfection Validation?
- Dr. Victoria Hitchins Remembered at Nelson Laboratories
- DuPont’s Tyvek Transition: Are You Prepared?
- Efficacy of Face Masks, Respirators and Face Coverings
- Endoscope Sampling Kit Now Available
- Ensuring that Plastic Devices Can Withstand Rigorous Disinfection Procedures
- EO Optimization and Potential Effects on Sterile Barrier Packaging
- EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7
- EO Sterilization Validation: Overkill with Benefits
- Equipment Cleaning, Disinfection, and Sterilization Validations – The Tissue Industry’s Compliance Challenge!
- Establishing Bioburden Alert and Action Levels
- Establishing the Proper Alcohol/Water Proportion for Simulating Solvents Used in Controlled Extraction Studies
- Establishing the Proper PH Range for Aqueous Simulating Solvents Used in Extractables Profiling
- Estimated Economic Impacts of the Two Year Moratorium on the Medical Device Excise Tax
- Ethylene Oxide Batch Release—Use for Specialized Medical Devices or Those that Need to Go to Trials
- EU MDR Delay: What Does It Mean for Biocompatibility and Chemical Characterization?
- Europe Working to Update Facemask Standard to Align with United States
- Evaluating The Impact of Change with Chemical Characterization
- Expanded Particulates Testing and Water System Testing and Services in Itasca, IL
- Extractable Chemical Characterization and Risk Assessment: What is the Worst-Case?
- Extractable/Leachable Chemistry Testing Strategies for Medical Devices
- FDA Guidance for ISO 10993-1: What to Expect
- FDA Proposes Ban on Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Gloves
- FDA Reclassifies Surgical Staplers and Staples
- FDA Releases ISO 10993-1 Guidance Document
- FDA Safety Notice: Lubricious Coating Separation on Intravascular Devices
- FDA Withdrawal of Temporary COVID-19 Pandemic Hand Sanitizer Manufacturing Guidelines: Additional Testing May Be Required
- Five Aspects of the ISO 11737-1:2018 Updates You Need to Know
- Flexible Endoscope Surveillance Testing Webinar Now Available
- Four Important Things to Know About Particulate Testing and Medical Devices
- FTIR in Assessment of Medical Devices
- Gibraltar Laboratories Changes Name to Nelson Labs
- Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry
- Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry
- Gram Stain Test Recommended for Genetic Testing
- Guidance on Combining Biocompatibility and Cleaning Validation Testing
- HealthPack 2020 Conference Summary
- Healthpack Conference 2018 Wrap Up
- How Chemical Characterization Can Supplement and Support Biocompatibility Testing
- How Clean is Clean Enough?
- How Clean is Your Cardiovascular Device?
- How Do You Select a Correct Artificial Test Soil for Cleaning Validations?
- How Much Protection Does Your Face Mask Offer?
- How Ready Are You for the Next Crisis?
- How the New FDA Biocompatibility Testing Guidance Could Affect You
- How To Handle An Emerging And Unexpected Drug Impurity
- How to Perform Cleaning Validations for Non-Critical Devices According to the New ANSI/AAMI ST98 Standard
- How to Select Sterile Barrier Systems for Reusable Medical Devices
- Human Factor Considerations for Medical Device Manufacturers
- I Have an Automated Cleaning Program, Should Thermal Disinfection be a Part of my Reprocessing Validations?
- Importance of Cleaning and Sterilization Validations, Even When they may Not be Required
- Important Considerations for Reusable Medical Endoscope Processing and Reprocessing
- Improving Medical Device Approval Timelines
- IMRP Roundup
- In vitro Irritation
- In Vitro Skin Irritation Breakthrough To Revolutionize Medical Device Testing
- In Vitro Skin Irritation Testing of Medical Devices
- Increase Efficiency by Combining Bioburden and Tests of Sterility
- Initial Evaluation Roadmap for Modern Microbial Methods
- Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing
- Is it a 6.0-log or a 6-log reduction?
- Is there a difference between treatment at point of use and pre-cleaning instructions?
- Is Your Biocompatibility Program on the Edge?
- Is Your New Device Clean? Learn More at BIOMEDevice Boston
- ISO 16775: The Medical Device Packaging Professional’s Latest “Must Have”
- ISO Committee Member Announced
- ISO Meeting and Biocompatibility Standards Update, Mishima, Japan
- ISO Meeting in Australia Updates International Standards for Medical Device Testing and Validation
- It’s time for your Annual Radiation Sterilization Assessment
- Jeffery Nelson Contributes on Panel for Biomed Professionals
- Justifying Family Groupings to Maximize Value for Cleaning and Sterilization
- Learn about Nelson labs Medical Packaging Validation 101 Webinar (Podcast)
- Lessons from the Lab eBook
- Leuven Open House Event 2023 – Presentations
- Limitations and Advances in Dissolution Testing
- LIVE Webinar: How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance
- Making the Grade: A Testing and Analysis Roundtable
- Manufacturers Should Test Tissue and Tissue Based Products for the Presence of Bacterial Endotoxins
- Marketing Hospital Textiles in the EU Market
- Martell Winters is Convener for ISO WG16
- Martell Winters Recognized at AATB
- Martell Winters Shares Expertise with University Students
- Mass Extraction makes FDA Consensus List
- Material Characterization/Extractable Leachable Testing Services May Lower Cost and Time Commitment
- MD&M Texas
- Mechanically Induced Hemolysis (ISO 10993-4)
- Medical Device Extractable and Leachables Testing in 2020
- Medical Device Extractables and Leachables Testing in 2020
- Medical Device Industry Approaches for Addressing Sources of Failing Cytotoxicity Scores
- Nelson Laboratories Celebrates 28 Years of Growth and Success
- Nelson Laboratories discusses masks, testing and adjusting operations
- Nelson Laboratories Launches New Tests
- Nelson Laboratories Now Performs Wet Bacterial Penetration Testing for EU
- Nelson Laboratories President/CEO Jeffery Nelson Talks MedTech With MDTmag.com
- Nelson Laboratories Science Council
- Nelson Laboratories Scientist Provides Clarification on Tissue Bank Cleaning Validations
- Nelson Laboratories Stays On Top of FDA Reusable Device Sterilization Guidelines and Changes
- Nelson Laboratories to Launch New Website
- Nelson Laboratories to Offer Free Biocompatibility Consultations During BIOMEDevice San Jose
- Nelson Laboratories To Provide Materials Selection, ISO 10993 and Reprocessing of Reusable Devices-Validation Updates at 2014 MD&M West
- Nelson Laboratories Utilizes Stromboli Oven Sample Changer with Karl Fischer Moisture Analysis
- Nelson Laboratories, Inc. Featured On Zions Bank Speaking On Business Radio Program
- Nelson Laboratories, Inc. Women in STEM Education (WISE) Committee
- Nelson Laboratories’ Experts Receive SOT Award
- Nelson Labs Adds New Quantitative Hemoglobin Assay to Improve Cleaning Validations
- Nelson Labs at Utah STEM Fest
- Nelson Labs Automates Bacterial Endotoxin Test
- Nelson Labs Contributes to STEM Education
- Nelson Labs Experts Invited to Present at Joint Conference
- Nelson Labs is an ASCA Accredited Testing Laboratory!
- Nelson Labs launches verification mark for masks and respirators
- Nelson Labs’ Scientists Awarded Best Published Paper 2017
- New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants
- New FDA Guidance on Gowns Intended for Use in Health Care Settings
- New FDA OSEL Research Programs Webpages
- New Manufacturers Jump Into Mask Making as Coronavirus Spreads
- New Mark Aims to Ease Mask and Respirator Testing Verification
- New US FDA Guidance on the Use of International Standard ISO 10993-1: Top 10 Changes
- Non-critical devices: How to choose between LLD or ILD?
- Non-Porous Packaging Validation
- OFFICIAL AMES REPORT ON HALO-RUBBER OLIGOMERS (C13) NOW AVAILABLE AT NELSON LABS EUROPE
- Open House to Celebrate Expanded and Upgraded Lab Facility in Itasca, IL
- Overlooked Considerations from EN 17141:2020 Clause 5
- Part I: Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
- Part II: Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
- Part III: Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
- Part IV: Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
- Particulate Matter Testing Required for Injectable Solutions
- Passing the Test
- Passing the test: Why patient safety is paramount
- Peaks and troughs: COVID-19 having mixed impacts on Utah’s once-vibrant biotech sector
- Physicochemical Testing Checks on Safety of Extracts
- Possible Replacement of the Rabbit Irritation Test with an In Vitro Model
- Proceed with Caution: Medtech Seeks Safe Packaging and Sterilization Solutions
- Programs funded to help interest students in Science, Technology, Engineering, and Math (STEM) in Utah schools
- Protein Residuals on Reusable Medical Devices and Patient Safety Impact
- Purple and Red: Gram Stain Test Contributes Important Information to the Sterilization Process
- Quick Guide to FDA’s Draft Guidance on 3D Printed Devices
- Rapid Sterility Testing: A New Solution For Short Shelf Life Products
- Regulatory Considerations and Revalidation Tests for Managing Change in Packaging Materials or Critical Supplies
- Reprocessing Single-Use Devices
- Reprocessing Validations for Hemodialysis Machines
- Requirements and Impact of the New Guideline – ISO 10993-23
- Reusable Advices For Reusable Medical Devices eBook
- Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles
- Revised EN13795 for European Gowns and Drapes Simplifies Results Interpretation
- Rigid Container Integrity Testing – Mass Extraction Simplified
- Rocking the Cradle or Rattling the Cage?
- Role of Solvent Selection for the Mass Spectrometric Analysis of Medical Devices in Extractables and Leachables (E&L) Testing
- Selecting & Justifying Sample Sizes: Where to Begin?
- Should all Steam Sterilization Cycle Parameter Sets Indicated in your IFU be Validated?
- Should simulated use testing always be a part of your reprocessing validations?
- Should you consider the quality of the water used during all stages of the healthcare reprocessing of medical devices?
- Should you name a detergent brand in the instructions for use (IFU) document?
- Single Use & Newly Manufactured Device Cleaning Validations
- Sounding Board: Looking Back at 2019 and Gazing at 2020
- Squeaky Clean: Orthopedic Device Packaging & Sterilization
- Standard Specification for Barrier Face Coverings
- Standardization of Test Soils for Reusable Medical Devices to Soon Become a Reality
- Sterilization Risk
- Successful Medical Device Cleaning Validations: What You Need to Know
- Supplier Stories for the Week: December 8, 2019
- Symposium Small Volume Parenteral Packaging from an Extractable & Leachable perspective 2022 – Presentations
- Testing 3D printed medical devices for biocompatibility
- Testing in Flux: Changing Protocols for a Transformative Industry
- Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges
- Testing the Safety and Efficacy of Multifunctional Personal Care Products, A Primer
- The Bumpy Road to MDR
- The Case against “Lazy” E&L-Identifications in GC/MS
- The Cobalt-60 Pioneers
- The MDR Delay’s Impact on Regulatory and Testing
- The Monocyte Activation Assay: The benefits of an animal-free test to show pyrogen-free pharmaceutical products
- The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
- The New and Improved ISO 10993-12:2021—What Is Really Changing?
- The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list
- The New FDA Draft guidance for Biocompatibility: What You Need to Know
- The Risk-Based “Big Three”
- The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of In Vitro and In Vivo testing results
- The Use and Utility of General Chemistry Data in Extractables Assessment
- Thought Leadership in Extractables & Leachables Testing
- Three-Day Webinar Series: Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes
- Time to Reclassify Noncriticial, Non-Patient-Contacting, Reusable Medical Devices?
- Tissue Processing Equipment Validations: What You Need To Know
- TOC Testing Verifies Acceptable Levels of Organic Carbon
- Tolerable Contact Limits for Ethylene Oxide Residual Testing
- Top 3 Questions About Extractable/Leachable Testing
- Transformative Testing: Addressing Patient Safety and Cybersecurity
- Tribute to Dr. Scott Sutton; Review of Bioburden Contamination Control
- U.S. ISO Certified Experts Announced
- Under what quality system should your reprocessing validation be performed?
- Understanding ASTM’s New Specification for Barrier Face Coverings
- Understanding Biological Evaluation Plans
- Understanding the EU Medical Device Regulation for Device Companies
- Understanding the Importance of TIR17 for Medical Device Manufacturers
- Understanding Validation for Verification Dose Maximum Sterilization
- Understanding Worst-case Conditions in ISO 18562 Testing
- UPDATE: Medtech contract manufacturers make it work during a pandemic
- Updated Lab Testing Methods to Safeguard Global Health eBook
- Updated Pyrogenicity Considerations for New Medical Devices
- Updates from ISO 10993 Working Groups Italy Session
- Use of Accelerated Conditions in Extractables and/or Leachables Studies
- Use of Exaggerated Surface Area to Solution Volume Ratios in Extractables Studies; Equilibrium Case
- USP Bioburden Control of Nonsterile Drug Substances and Products
- Visit Nelson Laboratories at OMTEC 2014
- Vitek or Genetic ID Testing: What They Are and How to Decide
- Water Systems and Regulatory Compliance: Is Your Water System Audit Ready?
- What About the Chemicals Used in Reprocessing Reusable Medical Devices?
- What are the Differences Between Respirators and Surgical Masks?
- What Cleaning Procedure Should You Have in Place For Your Reusable Device?
- What kind of terminal processing step should be in place after cleaning?
- What Medical Device Manufacturers Need to Know about FDA’s Predictive Toxicology Roadmap
- What should you consider when choosing a chemical disinfectant for your reusable device?
- What should you consider when choosing a detergent for your reusable device?
- What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Materials Selection and ISO 10993 Biocompatibility Update
- What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Packaging Test Methods for Validation of Sterile Barrier Materials
- What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Process Validations for Newly Manufactured Devices- Is Your New Device Clean?
- What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Validation Considerations for Managing Human Factors in Reprocessing of Reusable Devices
- What You’ll Learn by Attending the MD&M West Nelson Laboratories Classroom on Ethylene Oxide Sterilization Validation Overview
- What You’ll Learn by Attending the MD&M West Nelson Laboratories Classroom on Radiation Sterilization Validation Overview
- When Do I Really Need to Perform an EO Requalification?
- When do you need a drying step?
- When Drug Meets Device
- Which of the following cleaning procedure rinses are important?
- Which parameters must be validated during a steam sterilization validation?
- Why Extractables and Leachables Matter
- Why Particulate Matter Testing Matters: Cardiovascular Medical Device Testing
- WISE Committee Showcases STEM Careers
- Your MDR Strategy: Start with a Gap Analysis
News
- Acquisition of Montana-Based BioScience Laboratories
- Biocompatibility Advancements At MD&M Minneapolis
- BioScience Laboratories Gains CDC Approval to Test All Known Strains of SARS-CoV-2
- Celebrate 30 Years Of Life-Saving Innovation With Nelson Laboratories At MD&M West!
- Changes to Gibraltar Laboratories
- COVID-19 Continuity Plan
- European Union Grants a Good Manufacturing Practice Certificate to Nelson Laboratories
- Gerresheimer AG and Nelson Labs NV announce strategic alliance regarding E&L lab testing for the Pharmaceutical and Biotech Industries
- Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster
- Interview with Jos Bollen (Nelson Labs Europe) on Digitization (Belgian Business TV channel Kanaal Z-ICT)
- January 3, 2020 – New Legal Name for Gibraltar Laboratories
- MD&M West 2015: Celebrating 30 Years at the Forefront of Medtech Innovation
- Medical Device Testing Thought Leader Encourages Exploration Of Careers In Science
- Nelson Laboratories and Healthmark have Joined Forces to Offer a Surveillance Tool for Testing of Duoendoscopes
- Nelson Laboratories Celebrates 30 Years Supporting Life-Saving Medical Device Innovation
- Nelson Laboratories Expands Service to Medical Device Manufacturers in Europe, Israel, and Turkey
- Nelson Laboratories Expands Testing Capabilities With Dedicated Analytical Chemistry Lab
- Nelson Laboratories Gains Certification from Australia’s Therapeutic Goods Administration (TGA)
- Nelson Laboratories Honored as a Leader in Science and Technology
- Nelson Laboratories Joins the Orthopedic Discussion By Way of Sterile Packaging Validation at OMTEC 2014
- Nelson Laboratories Launches Consulting Services for MedTech Companies
- Nelson Laboratories Launches Redesigned Website
- Nelson Laboratories To Provide Materials Selection, ISO 10993 and Reprocessing of Reusable Devices-Validation Updates at 2014 MD&M West
- Nelson Laboratories’ Scientist to Present Medical Device Sterilization Updates at MD&M East Conference
- Nelson Labs Announces Changes to Secure Customer Portal
- Nelson Labs Announces Upcoming Symposium on E&L Challenges for Large Volume Parenteral Container Closure Systems
- Nelson Labs Earthquake & COVID-19 Continuity Plan — Update
- Nelson Labs is Now an ISTA® Certified Testing Laboratory
- Nelson Labs Launches New Global Website to Improve Med Tech & Pharma Customer Experience
- Nelson Labs Launches Verification Program to Help Consumers Identify Properly Tested Masks and Respirators
- Nelson Labs Receives ASCA (Accreditation Scheme for Conformity Assessment) Accreditation from the U.S. FDA
- Nelson Labs significantly expands lab operations and testing capabilities in Itasca, Illinois, to better serve customer needs
- Nelson Labs To Host Three Summer Career Open Houses
- Nelson Labs to Present Process Validations for Newly Manufactured Devices at BIOMEDevice Boston
- Nelson Labs Will Present on Medical Device Sterilization at MD&M Texas
- Nelson Labs® and Sterigenics® Open State-of-the-Art Laboratory and Expand Sterilization Facilities to Meet Growing Customer Demand in Europe
- Nemera and Nelson Labs Europe strengthen partnership to offer integrated services to customer
- NRCM Certifies Five Nelson Laboratories’ Microbiologists
- NRCM Certifies Seven Nelson Laboratories’ Microbiologists
- Scientists at Nelson Laboratories Discover Extractable Positive Control for In Vitro Skin Irritation Testing of Medical Devices
- Sotera Health Announces Acquisition of Wisconsin-Based Regulatory Compliance Associates
- Sotera Health Launches Free Digital Educational Platform from Industry Thought Leaders
- Sotera Health’s Sterigenics announces acquisition of Iotron Industries
- Sotera Health’s Nelson Labs announces acquisition of New Jersey-based Gibraltar Laboratories
- Sterigenics International and Noxilizer Announce Partnership
- Sterigenics International has Acquired Nelson Laboratories
- Sterigenics International LLC Acquires Toxikon’s European Laboratory Business
- Sterigenics International LLC Changes Name to Sotera Health LLC
