Канал: Nelson Labs

Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

Biocompatibility Testing, What You Need to Know

Biocompatibility Testing, What You Need to Know

Advancing Microbial-Contamination Detection Through Rapid Sterility Testing

Advancing Microbial-Contamination Detection Through Rapid Sterility Testing

What’s New with Reprocessing Validations for Reusable Medical Devices

What’s New with Reprocessing Validations for Reusable Medical Devices

Disinfectant Efficacy Testing on Site Specific Surfaces

Disinfectant Efficacy Testing on Site Specific Surfaces

Biocompatibility as a Critical Design Input

Biocompatibility as a Critical Design Input

Biocompatibility as a Critical Design Input

Biocompatibility as a Critical Design Input

How to design an Instruction For Use and validations for EU and US

How to design an Instruction For Use and validations for EU and US

The Impact of Physico-chemical Properties of Extractable Compounds on Their Analytical Responses

The Impact of Physico-chemical Properties of Extractable Compounds on Their Analytical Responses

A risk based approach towards the assessment of process equipment related leachables - case study

A risk based approach towards the assessment of process equipment related leachables - case study

Single-Use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers

Single-Use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers

What Really Changed: A Look at the Updated FDA Guidance Document for ISO 10993-1

What Really Changed: A Look at the Updated FDA Guidance Document for ISO 10993-1

Package Validations – Meeting the Requirements of ISO 11607

Package Validations – Meeting the Requirements of ISO 11607

The Impacts of Updated Standards on IFU Validations for Reusable Medical Device

The Impacts of Updated Standards on IFU Validations for Reusable Medical Device

Meeting New Challenges in Toxicological Risk Assessment: Pending Updates to ISO 10993-17

Meeting New Challenges in Toxicological Risk Assessment: Pending Updates to ISO 10993-17

Medical Device Chemical Characterization

Medical Device Chemical Characterization

Using the Chemistry of Halogenated Rubber Oligomers in Identifying Unknowns in Extractables Studies

Using the Chemistry of Halogenated Rubber Oligomers in Identifying Unknowns in Extractables Studies

Perform cleaning validations of reusable medical devices after publication of ANSI_AAMI ST98:2022

Perform cleaning validations of reusable medical devices after publication of ANSI_AAMI ST98:2022

Packaging related nitrosamines in Drug Products

Packaging related nitrosamines in Drug Products

Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2

Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2

What Makes a Successful ISO 18562 Toxicological Risk Assessment?

What Makes a Successful ISO 18562 Toxicological Risk Assessment?

Biofilm in Health Care Products – Key Considerations in Biofilm Management

Biofilm in Health Care Products – Key Considerations in Biofilm Management

How Should Disinfection Validations be Performed for Reusable Medical Devices?

How Should Disinfection Validations be Performed for Reusable Medical Devices?

A Basic Overview of Sterilization Validations (Reusable Medical Devices)

A Basic Overview of Sterilization Validations (Reusable Medical Devices)

A Complete Guide to Cleaning Validations (Reusable Medical Devices)

A Complete Guide to Cleaning Validations (Reusable Medical Devices)

NVR Reconciliation – Expectations versus Reality

NVR Reconciliation – Expectations versus Reality

Designing a Biocompatibility and Chemical Characterization Strategy

Designing a Biocompatibility and Chemical Characterization Strategy

Looking into the Future of Extractable testing to support Chemical Characterization

Looking into the Future of Extractable testing to support Chemical Characterization

Approaches in the Quantitation Strategy for Results of a Non-Targeted Screening Analysis

Approaches in the Quantitation Strategy for Results of a Non-Targeted Screening Analysis

Container Closure Integrity Testing (CCIT) for Pharmaceutical Sterile Barrier Packaging

Container Closure Integrity Testing (CCIT) for Pharmaceutical Sterile Barrier Packaging

Good Identification Practices in Non-Targeted Screening Analyses

Good Identification Practices in Non-Targeted Screening Analyses

Antimicrobial Treatments, Finishes and Surfaces – Understanding Testing Options

Antimicrobial Treatments, Finishes and Surfaces – Understanding Testing Options

Viral Clearance: Removal of Viral Contamination in Biopharmaceutical Manufacturing

Viral Clearance: Removal of Viral Contamination in Biopharmaceutical Manufacturing

Developing Contamination Control Strategy

Developing Contamination Control Strategy

ISO 10993-18 - Introduction to Extractables and Leachables testing for medical devices

ISO 10993-18 - Introduction to Extractables and Leachables testing for medical devices

ISO 10993-1: a matchmaker guide

ISO 10993-1: a matchmaker guide

Big Changes to ISO 10993-1, What is Happening to the Main Biocompatibility Standard Now?

Big Changes to ISO 10993-1, What is Happening to the Main Biocompatibility Standard Now?

Introduction to Sotera Health and it’s businesses units

Introduction to Sotera Health and it’s businesses units

Impact of Device Changes on Biocompatibility

Impact of Device Changes on Biocompatibility

Bioburden testing & organism characterization: Enhanced guidance for low-sterilization dose products

Bioburden testing & organism characterization: Enhanced guidance for low-sterilization dose products

Preparing a Device Master Record (DMR)

Preparing a Device Master Record (DMR)

Controlling Endotoxins Contamination during Pharmaceutical Production

Controlling Endotoxins Contamination during Pharmaceutical Production

Frequently Asked Questions about Combination Products

Frequently Asked Questions about Combination Products

Switching Sterilization: What Should You Consider When Changing Processes

Switching Sterilization: What Should You Consider When Changing Processes

Removing rabbits from irritation testing: Regulatory acceptance of ISO 10993-23

Removing rabbits from irritation testing: Regulatory acceptance of ISO 10993-23

Sterilization and Sterility Verification of Single Use Systems

Sterilization and Sterility Verification of Single Use Systems

Skin-Care Products: Understanding Clinical Testing Options

Skin-Care Products: Understanding Clinical Testing Options

Is it time to re-evaluate your Design History File (DHF)?

Is it time to re-evaluate your Design History File (DHF)?

The Biocompatibility Trail: A challenging hike towards animal free testing

The Biocompatibility Trail: A challenging hike towards animal free testing

Biocompatibility/Biosafety: Evaluating the Impact of a Change

Biocompatibility/Biosafety: Evaluating the Impact of a Change

Appropriate uses for Product Sterility Testing – when is sterility testing appropriate

Appropriate uses for Product Sterility Testing – when is sterility testing appropriate

EPA Regulatory Guidelines and Testing for Residual Efficacy Products

EPA Regulatory Guidelines and Testing for Residual Efficacy Products

Cleaning Validation Roadmap for Reusable Medical Devices

Cleaning Validation Roadmap for Reusable Medical Devices

The Future of Biocompatibility Testing Might Just be Animal Free!

The Future of Biocompatibility Testing Might Just be Animal Free!

Release & Stability Testing Requirements for Parenteral Drug Products

Release & Stability Testing Requirements for Parenteral Drug Products

Intro to Evaluating Persistent or Residual Antimicrobial Efficacy of Topically Applied Products

Intro to Evaluating Persistent or Residual Antimicrobial Efficacy of Topically Applied Products

Guidance for Understanding Container Closure Integrity Test Failures

Guidance for Understanding Container Closure Integrity Test Failures

Medical Device Biofilms: Slimy, Sticky, Stubborn, and Serious

Medical Device Biofilms: Slimy, Sticky, Stubborn, and Serious

Packaging: Evaluating the Impact of a Change

Packaging: Evaluating the Impact of a Change

Packaging: Evaluating the Impact of a Change

Packaging: Evaluating the Impact of a Change

Ethylene Oxide & Radiation Sterilization: Evaluating the Impact of a Change

Ethylene Oxide & Radiation Sterilization: Evaluating the Impact of a Change

Slimy Biofilms: A Brief Overview

Slimy Biofilms: A Brief Overview

Contamination control for pharmaceutical products: real-world moist heat validation pitfalls

Contamination control for pharmaceutical products: real-world moist heat validation pitfalls

Essential Principles of Chemical Characterization Applied to Small Volume Parenterals (SVPs)

Essential Principles of Chemical Characterization Applied to Small Volume Parenterals (SVPs)

Analytical Approaches used in E&L studies

Analytical Approaches used in E&L studies

The Challenges in Tox Assessments for Small Volume ParenteralPackaging System Applications

The Challenges in Tox Assessments for Small Volume ParenteralPackaging System Applications

N-Nitrosamines in Primary Packaging for SVP’s

N-Nitrosamines in Primary Packaging for SVP’s

Primary Packaging Considerations from a Biologics ProductDevelopment Perspective

Primary Packaging Considerations from a Biologics ProductDevelopment Perspective

The Necessity of E&L Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.

The Necessity of E&L Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.

Setting up Extractables & Leachables Studies for Small VolumeParenteral Applications

Setting up Extractables & Leachables Studies for Small VolumeParenteral Applications

SVP Packaging - NB Persepective on CE-marked Medical Devices-Article 117 MDR Combination Products

SVP Packaging - NB Persepective on CE-marked Medical Devices-Article 117 MDR Combination Products

Rubber Oligomers

Rubber Oligomers

Reactive Leachables

Reactive Leachables

US Drug Delivery Combination Product Regulatory

US Drug Delivery Combination Product Regulatory

How to escape from a cytotoxicity failure? - Audrey P. Turley & Lise Vanderkelen

How to escape from a cytotoxicity failure? - Audrey P. Turley & Lise Vanderkelen

Reprocessing Validations: Flexible Endoscopes and AAMI ST91

Reprocessing Validations: Flexible Endoscopes and AAMI ST91

A Structured Approach to Selection of Container Closure Materials for Small Volume Parenterals

A Structured Approach to Selection of Container Closure Materials for Small Volume Parenterals

Radiation Sterilization of SVPP: RTU and fill/finished. Do not defaultto 25 kGy – 40 kGy

Radiation Sterilization of SVPP: RTU and fill/finished. Do not defaultto 25 kGy – 40 kGy

Extractables & Leachables Testing of Single-Use Systems for Production - Karen Pieters

Extractables & Leachables Testing of Single-Use Systems for Production - Karen Pieters

Virucidal Efficacy Testing for Submission to Regulatory Agencies

Virucidal Efficacy Testing for Submission to Regulatory Agencies

Big Changes to ISO 10993-1, what is happening to the main biocompatibility standard now?

Big Changes to ISO 10993-1, what is happening to the main biocompatibility standard now?

Polymer-based, Pre-filled Syringes designed to Minimize the Aggregation Risk of Sensitive Biodrugs

Polymer-based, Pre-filled Syringes designed to Minimize the Aggregation Risk of Sensitive Biodrugs

Nelson Labs Mark

Nelson Labs Mark

Rubber Manufacturing and Composition of Pharma Rubbers - Tine Hardeman PhD - Datwyler

Rubber Manufacturing and Composition of Pharma Rubbers - Tine Hardeman PhD - Datwyler

Shortages of critical raw materials and managing changes and substitutions - Dennis Jenke

Shortages of critical raw materials and managing changes and substitutions - Dennis Jenke

Manufacturing an SVP Drug Containment Solution: Quality by Design - Daniel Martinez, Stevanato Group

Manufacturing an SVP Drug Containment Solution: Quality by Design - Daniel Martinez, Stevanato Group

How mass spectrometry can give you very good ID’s- Ward d'Autry

How mass spectrometry can give you very good ID’s- Ward d'Autry

Shortages of critical raw materials and managing changes & substitutions Dennis Jenke, Nelson Labs

Shortages of critical raw materials and managing changes & substitutions Dennis Jenke, Nelson Labs

On the Origin of Extractable Species - Piet Christiaens, Scientific Director Nelson Labs

On the Origin of Extractable Species - Piet Christiaens, Scientific Director Nelson Labs

Chemical Characterization According to Iso10993 18 - Dries Cardoen

Chemical Characterization According to Iso10993 18 - Dries Cardoen

Failure Investigation - Routine BI Positive - Gregory Grams

Failure Investigation - Routine BI Positive - Gregory Grams

The Current Regulatory Acceptance of In Vitro Alternatives for Biocompatibility

The Current Regulatory Acceptance of In Vitro Alternatives for Biocompatibility

Overcoming a Cytotoxicity Failure-Lise Vanderkelen

Overcoming a Cytotoxicity Failure-Lise Vanderkelen

FDA Regulation of Hand Sanitizers; What Testing Should be Conducted to Market a New Hand Sanitizer?

FDA Regulation of Hand Sanitizers; What Testing Should be Conducted to Market a New Hand Sanitizer?

Thor Rollins interviewed at MDM West

Thor Rollins interviewed at MDM West

Biocompatibility Testing & Evaluations: Meeting Target Deadlines in a Highly Constrained Environment

Biocompatibility Testing & Evaluations: Meeting Target Deadlines in a Highly Constrained Environment

Disinfectant Efficacy Testing Study Design & Data Interpretation for the U.S. EPA

Disinfectant Efficacy Testing Study Design & Data Interpretation for the U.S. EPA

2022 State of the Medical Device Industry: Quality, Biocompatibility, and Changing Regulations

2022 State of the Medical Device Industry: Quality, Biocompatibility, and Changing Regulations

Calling Attention to Burkholderia spp., & Mitigating Risk Through a Robust Preservative System

Calling Attention to Burkholderia spp., & Mitigating Risk Through a Robust Preservative System

Nelson Labs On the Origin of Extractables Species - Piet Christiaens

Nelson Labs On the Origin of Extractables Species - Piet Christiaens

Risk Assessment for Single Use Systems: USP 665 vs. BPOG

Risk Assessment for Single Use Systems: USP 665 vs. BPOG

The Testing and Risk Management Impacts of Changing a Medical Device

The Testing and Risk Management Impacts of Changing a Medical Device

Disinfectant Efficacy Testing – Coupon/Carrier Method

Disinfectant Efficacy Testing – Coupon/Carrier Method

Symposium 2022-Small Volume Parenteral Packaging-March 30 & 31

Symposium 2022-Small Volume Parenteral Packaging-March 30 & 31

Cleaning Evaluations of Newly Manufactured Devices

Cleaning Evaluations of Newly Manufactured Devices

Strategies for Testing Hemocompatibility and Potential Upcoming Changes

Strategies for Testing Hemocompatibility and Potential Upcoming Changes

Current regulatory trends around extractable & leachable testing, what we are hearing from the FDA

Current regulatory trends around extractable & leachable testing, what we are hearing from the FDA

The Current State of Biocompatibility: How FDA & CE Are Looking at Biocompatibility

The Current State of Biocompatibility: How FDA & CE Are Looking at Biocompatibility

Nelson Lab Wiesbaden

Nelson Lab Wiesbaden

The Necessity of Extractables & Leachables Qualifications for Lyophilized Drug Products

The Necessity of Extractables & Leachables Qualifications for Lyophilized Drug Products

Sterility,Manufacturing & Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals

Sterility,Manufacturing & Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals

Upcoming Changes to Cleaning Validations for Reusable Medical Devices

Upcoming Changes to Cleaning Validations for Reusable Medical Devices

Drug device combination products Lise Vanderkelen

Drug device combination products Lise Vanderkelen

Assessing the Safety of Extractables and Leachables for Drug Products: When and How?

Assessing the Safety of Extractables and Leachables for Drug Products: When and How?

The challenges in tox assessments for large volume parenteral packaging system applications

The challenges in tox assessments for large volume parenteral packaging system applications

Who is Sotera Health?

Who is Sotera Health?

Nelson Labs Wiesbaden

Nelson Labs Wiesbaden

The need for a higher level of identifications in large volume parenteral packaging qualifications

The need for a higher level of identifications in large volume parenteral packaging qualifications

Testing of the drug product, stored in a LVP packaging system: Leachable study design and challenges

Testing of the drug product, stored in a LVP packaging system: Leachable study design and challenges

The value of simulation studies for LVP packaging systems

The value of simulation studies for LVP packaging systems

Testing of the packaging: Extractable study design and challenges

Testing of the packaging: Extractable study design and challenges

Filter Sterilization Validations

Filter Sterilization Validations

Biocompatibility Evaluation for Device Submission

Biocompatibility Evaluation for Device Submission

Use of auxiliary information to support the development and qualification of flexible LVP packaging

Use of auxiliary information to support the development and qualification of flexible LVP packaging

Challenges and considerations for complex LVP drug products

Challenges and considerations for complex LVP drug products

Notified body perspective on CE-marked medical devices versus article 117 MDR combination products

Notified body perspective on CE-marked medical devices versus article 117 MDR combination products

The design and qualification process for a LVP packaging system from a user perspective

The design and qualification process for a LVP packaging system from a user perspective

Bioburden Alert and Action Levels – Low hanging fruit for a FDA Citation

Bioburden Alert and Action Levels – Low hanging fruit for a FDA Citation

Blow-fill-seal technology in large volume parenteral packaging

Blow-fill-seal technology in large volume parenteral packaging

Design Change Impact on Biocompatibility and Documentation

Design Change Impact on Biocompatibility and Documentation

The production process and qualification of film: A film manufacturer perspective

The production process and qualification of film: A film manufacturer perspective

Cleaning, Disinfection & Sterilization of Medical Devices:Updates to Reprocessing Guidance Documents

Cleaning, Disinfection & Sterilization of Medical Devices:Updates to Reprocessing Guidance Documents

Cytotoxic Reactivity: Understanding the Cause and the Path Forward

Cytotoxic Reactivity: Understanding the Cause and the Path Forward

After E&L: Updates to the Standard for Toxicological Risk Assessment 10993-17

After E&L: Updates to the Standard for Toxicological Risk Assessment 10993-17

Nelson Labs 4 Anja Gottschalk Borealis 15 15

Nelson Labs 4 Anja Gottschalk Borealis 15 15

Intro to large volume parenterals (LVPs) as a pharmaceutical dosage form and an E&L challenge

Intro to large volume parenterals (LVPs) as a pharmaceutical dosage form and an E&L challenge

Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18

Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18

WISE Scientist Stories Maria Salazar

WISE Scientist Stories Maria Salazar

WISE Scientist Stories Megan Moffat

WISE Scientist Stories Megan Moffat

Nelson Labs 1 Eric Meyers Nelson Labs Presentation 13 40

Nelson Labs 1 Eric Meyers Nelson Labs Presentation 13 40

Primary and Secondary Packaging as potential source of Nitrosamines: impact on E&L Study design

Primary and Secondary Packaging as potential source of Nitrosamines: impact on E&L Study design

Risk Assessment for Potential Elemental Impurities on Drug Products/Medical Devices

Risk Assessment for Potential Elemental Impurities on Drug Products/Medical Devices

Whirlwind of Change: How New Standards, MDR, and Brexit are Impacting Biocompatibility

Whirlwind of Change: How New Standards, MDR, and Brexit are Impacting Biocompatibility

The Big Three: Cytotoxicity, Sensitization & Irritation Testing

The Big Three: Cytotoxicity, Sensitization & Irritation Testing

Packaging Validation 101, Part 2 Process Validation

Packaging Validation 101, Part 2 Process Validation

Packaging Validation 101

Packaging Validation 101

Hunt for N-nitrosamines in medicinal products

Hunt for N-nitrosamines in medicinal products

Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

Best Practices When Validating Reusable Devices

Best Practices When Validating Reusable Devices

Impact of MDR on Biocompatibility, a Shortage of Expertise

Impact of MDR on Biocompatibility, a Shortage of Expertise

Thermal Disinfection & Steam Sterilization Validation for Reusable Devices

Thermal Disinfection & Steam Sterilization Validation for Reusable Devices

Evaluating the biocompatibility of reusable medical devices during their whole life cycle

Evaluating the biocompatibility of reusable medical devices during their whole life cycle

Decontamination, Sterile Processing, and Performance Testing of Personal Protective Equipment (PPE)

Decontamination, Sterile Processing, and Performance Testing of Personal Protective Equipment (PPE)

MDR with Brexit, how the combination is impacting the European medical device industry.

MDR with Brexit, how the combination is impacting the European medical device industry.

Requirements and Impact of the New Guideline - ISO 10993-23: Tests for Irritation

Requirements and Impact of the New Guideline - ISO 10993-23: Tests for Irritation

Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial

Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial

Validating, Optimizing and Monitoring EO Sterilization Processes, Day 2

Validating, Optimizing and Monitoring EO Sterilization Processes, Day 2

Container Closure Integrity and Stability Testing for Rigid Containers

Container Closure Integrity and Stability Testing for Rigid Containers

Future Trends To Control Risks From Extractables and Leachables

Future Trends To Control Risks From Extractables and Leachables

Validating, Optimizing and Monitoring EO Sterilization Processes, Day 1

Validating, Optimizing and Monitoring EO Sterilization Processes, Day 1

2021 01 25 NEW Webinar Disinfection Validation - Lise Vanderkelen

2021 01 25 NEW Webinar Disinfection Validation - Lise Vanderkelen

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin

A delay in MDR? Where are we now?

A delay in MDR? Where are we now?

Cleaning validations for reusable devices

Cleaning validations for reusable devices

Testing requirements for medical face coverings

Testing requirements for medical face coverings

The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products

The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products

STEM Utah

STEM Utah

Extractables and leachables testing of a combination device

Extractables and leachables testing of a combination device

Recent FDA biocompatibility feedback from 510k submissions

Recent FDA biocompatibility feedback from 510k submissions

The Biological Evaluation Plan (BEP)

The Biological Evaluation Plan (BEP)

Why is the sterility of your drug product much more than just a test of sterility?

Why is the sterility of your drug product much more than just a test of sterility?

Necessity of Extractable & Leachable Qualification for Lyophilized Drug Products:Fallacies Addressed

Necessity of Extractable & Leachable Qualification for Lyophilized Drug Products:Fallacies Addressed

Unknowns, TICs, and Identified Compounds Below the TTC

Unknowns, TICs, and Identified Compounds Below the TTC

Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting

Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting

Bacterial Endotoxin Testing; History, Inhibition/Enhancement, and Process Control

Bacterial Endotoxin Testing; History, Inhibition/Enhancement, and Process Control

Changing Regulatory Requirements for E&L Testing on Pharmaceutical Packaging Systems

Changing Regulatory Requirements for E&L Testing on Pharmaceutical Packaging Systems

Key Elements of a Sterility Assurance Program

Key Elements of a Sterility Assurance Program

Meeting Requirement 10.4 of the MDR – How to Address CMRs?

Meeting Requirement 10.4 of the MDR – How to Address CMRs?

Discussion of Feedback Received Directly from FDA on ChemTox

Discussion of Feedback Received Directly from FDA on ChemTox

Shifting Requirements Within the FDA: Expectations in Chemistry Study Design

Shifting Requirements Within the FDA: Expectations in Chemistry Study Design

Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces

Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces

Chemical characterization on a combination device from Biological Evaluation Plan to practice

Chemical characterization on a combination device from Biological Evaluation Plan to practice

A Year of EU MDR Remediation: Biocompatibility Strategies and Lessons Learned

A Year of EU MDR Remediation: Biocompatibility Strategies and Lessons Learned

Medical Device Packaging Trends Leading to Increased 483’s

Medical Device Packaging Trends Leading to Increased 483’s

Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE)

Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE)

COVID 19, what we learned from the race to supply the market with respirators, masks, and other PPE.

COVID 19, what we learned from the race to supply the market with respirators, masks, and other PPE.

Recent FDA Feedback Regarding Extractable and Leachable Testing

Recent FDA Feedback Regarding Extractable and Leachable Testing

Identifying & Mitigating Errors in Organic Extractables & Leachables Screening

Identifying & Mitigating Errors in Organic Extractables & Leachables Screening

Reprocessing Validations of Reusable Medical Devices

Reprocessing Validations of Reusable Medical Devices

If something looks clean, is it really clean? Cleaning validations for reusable devices

If something looks clean, is it really clean? Cleaning validations for reusable devices

Sterilization of your Medical Device

Sterilization of your Medical Device

Addressing Common Observations in Regulatory Submissions of Chemical Characterization Results

Addressing Common Observations in Regulatory Submissions of Chemical Characterization Results

A Guide to Emergency Use Authorization of Gas Path Devices

A Guide to Emergency Use Authorization of Gas Path Devices

Pharma Packaging Considerations for Radiation Processing

Pharma Packaging Considerations for Radiation Processing

What Endpoints Can Be Assessed In A Toxicological Risk Assessment?

What Endpoints Can Be Assessed In A Toxicological Risk Assessment?

How to select a CRO for Chemical Characterization Testing

How to select a CRO for Chemical Characterization Testing

The need to Identify “Unknowns” from a Risk Management Perspective

The need to Identify “Unknowns” from a Risk Management Perspective

Approach to Assessing Change in Medical Devices from a Biocompatibility Perspective

Approach to Assessing Change in Medical Devices from a Biocompatibility Perspective

Biological Evaluation Plan: A crucial first step in the Biocompatibility evaluation of a Med Device

Biological Evaluation Plan: A crucial first step in the Biocompatibility evaluation of a Med Device

Sotera Health - Safeguarding Global Health During COVID-19

Sotera Health - Safeguarding Global Health During COVID-19