Header Artwork

Curated content from industry thought leaders. From Introductory sterilization and lab testing topics to advanced, in-depth learnings, our expert advisors have filled this academy with cutting-edge educational content and resources to help you mitigate risk, go to market faster, and achieve excellence in your field. As you learn through this site, please know that our experts stand ready to assist you along the way. Explore all we have to offer.

75+ experts in their fields of study

100+ hours of curated content

150+ Webinars, whitepapers, eBooks, and more

Register  or   Log In  to immerse yourself today.

If you are new to Sotera Health, you can learn more about our best-in-class businesses by visiting our Sotera Health, Sterigenics, Nelson Labs, and Nordion websites.

WATCH THE ACADEMY VIDEO

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

The Use and Utility of General Chemistry Data in Extractables Assessment

Use of Exaggerated Surface Area to Solution Volume Ratios in Extractables Studies; Equilibrium Case

Why Extractables and Leachables Matter

Cytotoxic Reactivity Understanding the Cause and the Path Forward

Face Masks and Respirators

ICH Stability Testing and Method Development

Mass Extraction Container Closure "CCIT" for Rigid Containers

MPO Packaging Validations – A Look at Current and Future State Testing

Packaging Validations - A look at Current and Future State Testing

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

Biocompatibility and the New MDR

An Introduction to large volume parenterals (LVPs) as a pharmaceutical dosage form

The Essence Of The EU MDR and its Key Consequences

The New ISO 10993 – 18 Standard and its Impact on Chemical Characterization of Medical Devices

MDR/IVDR – How MedPharmPlast is Helping Overcoming the Potential Challenges

Upcoming Changes to Cleaning Validations for Reusable Medical Devices

Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Health Care Application

Changes in the Packaging Environment Relating to Regulations and Test Methods

Selecting & Justifying Sample Sizes: Where to Begin?

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

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

Packaging Design Validation Testing

The Production Process and Qualification of a Pharmaceutical Film

Hunt for N-nitrosamines in Medicinal Products

Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993-1:2018

Becoming Compliant with the MDRs, A Real Life Case Study

Chemical Disinfection Validations for Reusable Device

Design Control for the Contract Research Organization

Transportation and Distribution Testing for Medical Devices

Reprocessing Validations of Reusable Medical Devices

The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

The Testing and Risk Management Impacts of Changing a Medical Device

Benefits of Premarket and Postmarket Particulate Testing of Cardiovascular Devices

Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial

Biocompatibility: Applying the New ISO 10993 Standards

Biocompatibility of Raw Materials for Medical Devices

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

Best Practices When Validating Reusable Devices

How to Address Regulatory Change in Your Current Biocompatibility Program

The Design and Qualification Process for a LVP Packaging System from a User Perspective

E&L Testing of Single-Use Systems for Production

Packaging Validation 101

A Stepwise Approach to Deal with In Vitro Cytotoxicity Failures

Single Use & Newly Manufactured Device Cleaning Validations

Successful Medical Device Cleaning Validations: What You Need to Know

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

Extractables and leachables testing of a combination device: testing in between regulations for pharmaceutical products and medical devices

Guidance for Cleaning, Disinfection and Sterilization of Reusable Medical Devices

Design Change Impact on Biocompatibility and Documentation

Ethylene Oxide Sterilization, Revision of Annex E, Single Batch Release

Reusable Advices For Reusable Medical Devices

Disinfectant Efficacy Testing for Submission to the US Environmental Protection Agency

Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

Understanding the EU Medical Device Regulation for Device Companies

Designing an End-to-End Sterility Assurance Program

Microbiological Control in a Pharmaceutical Manufacturing Environment

DISINFECTION VALIDATION: How to Classify and Validate Your Medical Device Disinfection Process

N-Nitrosamines in Primary Packaging for SVP’s

2022 Nelson Labs Virtual Symposium

EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7

Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016

Establishing the Proper Alcohol/Water Proportion for Simulating Solvents Used in Controlled Extraction Studies

Use of Accelerated Conditions in Extractables and/or Leachables Studies

Irritation Testing is Becoming Less Irritating

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)

Packaging Trends Leading to Increased 483’s

Recent FDA biocompatibility feedback from 510k submissions

The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed

Bioburden Alert and Action Levels – Low Hanging Fruit for a FDA Citation

The Big Three: Cytotoxicity, Sensitization & Irritation Testing

Changes to ISO10993-1 and relationship to Medical Device Regulation

Cleaning Validations for Reusable Devices A Road Trip to the EU and US Market

Container Closure Integrity and Stability Testing for Rigid Containers

Shifting Requirements Within the FDA: Expectations in Chemistry Study Design

LVP Polyolefin Solutions Addressing Different Packaging and Regulatory Requirements

An Outline of Current Medical Face Mask Performance Requirements and Testing

Packaging Design for Sterilization

Challenges and Considerations for Complex LVP Drug Products

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

Primary and Secondary Packaging Materials as Potential Source of Nitrosamines

Cytotoxicity Failure What Now

Cleaning Validations for Newly Manufactured Medical Devices

Preservative Effectiveness Testing - Calling Attention to Burkholderia SPP

What is Changing in the Realm of Validations Regarding Reusable Devices?

Coronavirus & Barrier Material Tests

Considerations for Third Party Reprocessing of Single-Use Medical Devices

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

FDA Feedback Reguarding Chemistry for Toxicological Risk Assessment - How to Make Sure FDA will Accept Your Protocol

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

Navigating Packaging Changes in Light of New Regulatory Requirements

Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces

Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry

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

Meeting the Requirements of 10.4 of MDR How to Address CMRs

Chemical Characterization on a Combination Device for Biological Evaluation Plan to Practice

Discussion of Feedback Received Directly from FDA on ChemTox

3D Printed Medical Devices and Biocompatibility Whitepaper

Get the Facts on Microbial Reduction in Food Ingredients

Key Elements of a Sterility Assurance Program

Future Trends To Control Risks From Extractables and Leachables

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

Material Consideration Radiation Processing

Regulatory Landscape for EO Residue Levels in Medical Devices

Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993-1:2018

Becoming Compliant with the MDRs, A Real Life Case Study

Chemical Disinfection Validations for Reusable Device

Design Control for the Contract Research Organization

Transportation and Distribution Testing for Medical Devices

How to Evaluate a New Product Against an Existing Product in a Validated EO Process

Reprocessing Validations of Reusable Medical Devices

The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list

The Testing and Risk Management Impacts of Changing a Medical Device

Benefits of Premarket and Postmarket Particulate Testing of Cardiovascular Devices

Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial

Biocompatibility: Applying the New ISO 10993 Standards

Biocompatibility of Raw Materials for Medical Devices

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

Best Practices When Validating Reusable Devices

Product Safety Future State of Sterility Assurance and the Role of Terminal Sterilization

Setting up Extractables & Leachables Studies for Small Volume Parenteral Applications

Packaging Validation 101

Get the Facts on Bioburden Control and Sterilization for Food & Beverage Packaging

Single Use & Newly Manufactured Device Cleaning Validations

Successful Medical Device Cleaning Validations: What You Need to Know

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

Extractables and leachables testing of a combination device: testing in between regulations for pharmaceutical products and medical devices

Guidance for Cleaning, Disinfection and Sterilization of Reusable Medical Devices

Cobalt-60: The Heart of Radiation Sterilization

Design Change Impact on Biocompatibility and Documentation

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

Combination Products and Parenteral Packaging a US Perspective

Primary Packaging Considerations from a Biologics Product Development Perspective

Disinfectant Efficacy Testing for Submission to the US Environmental Protection Agency

Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

Understanding the EU Medical Device Regulation for Device Companies

Microbiological Control in a Pharmaceutical Manufacturing Environment

DISINFECTION VALIDATION: How to Classify and Validate Your Medical Device Disinfection Process

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

Combination Products and Parenteral Packaging: A Notified Body (EU) Perspective

Sterilization Dose Audits – The “Why” and the “How”

N-Nitrosamines in Primary Packaging for SVP’s

2022 Nelson Labs Virtual Symposium

EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7

Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016

Disinfectant Efficacy Testing Coupon/Carrier Method

Testing and Risk Management Impacts Changing Medical Device

Why is the Sterility of your Drug Product much more than just a Test of Sterility?

FDA Regulation of Hand Sanitizers - What Testing Should be conducted to Markt a new Hand Sanitizer?

FAQs for Pet Treats Manufacturers: Get the Facts on Pathogen Reduction in Pet and Animal Nutrition

3D Printed Medical Devices and Biocompatibility Whitepaper

Choosing Colorants for Medical Devices

A Delay in MDR? Where are we now?

If Something Looks Clean, Is It Really Clean? Cleaning Validations for Reusable Devices

MDR Effects on Cleaning and Sterilization Validations

MDR with Brexit_ How the Combination is Impacting the European Medical Device Industry

The Biological Evaluation Plan (BEP): A crucial first step in the Biocompatibility evaluation of a Medical Device

Identifying and Mitigating Errors in Organic Extractables and Leachables Screening

Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems

Do's and Don't in setting up Extractables and Leachable Studies, taking into account Existing Standards Guidelines and Recommendations

On the Origin of Extractable Species

Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges

Considerations for Third-Party Reprocessing of Single-Use Medical Devices

When Drug Meets Device

Cleaning, Disinfection and Sterilization of Medical Devices: Updates to Reprocessing Guidance Documents AAMI TIR 12 and TIR30 (ST98)

When Drug meets Device: How to assess compatibility?

Thermal Disinfection & Steam Sterilization Validation for Reusable Devices

Medical Device Extractable and Leachables Testing in 2020

Chemical Interactions between Leachables and Biopharmaceuticals

Pharma Packaging Considerations for Radiation Processing using Gamma and Electron Beam and Discussion on the New Container Closure Integrity Testing

The Necessity of Extractables and Leachables Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.

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

Manufacturing an SVP Drug Containment Solution: Quality by Design

Rubber Manufacturing and Composition of Pharma Rubbers

The Road to Market Authorization for Sterile Medical Devices within the European Union

Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization

Three Methods to Establish the Sterilization Dose of a Medical Device

Impact of MDR on Biocompatibility, a Shortage of Expertise

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

Biocompatibility Fundamentals for Medical Devices

Critical First Steps of an Ethylene Oxide (EO) Validation - Process Definition The Critical First Steps in the Validation of an EO Sterilization Process

The Road to Parametric Release for EO Sterilization

Materials Qualification of Healthcare Products to Radiation Sterilization

Get the Facts on Microbial Reduction in Food Ingredients

Performance Qualification for Gamma Irradiators

What is a Sterilization Dose Audit and How are they Performed?

Tools of the Trade Ways to make EO Processing More Efficient

Material Consideration Radiation Processing

Regulatory Landscape for EO Residue Levels in Medical Devices

How to Evaluate a New Product Against an Existing Product in a Validated EO Process

The Design and Qualification Process for a LVP Packaging System from a User Perspective

Product Safety Future State of Sterility Assurance and the Role of Terminal Sterilization

Medical Packaging and the Impact of NO2 Sterilization

Radiation Sterilization Strategies for Improved Processing Options and Timing

Get the Facts on Bioburden Control and Sterilization for Food & Beverage Packaging

A Review of Ionizing Radiation Sterilization Modalities

Establishing Maximum Acceptable Dose in Radiation Sterilization

Cobalt-60: The Heart of Radiation Sterilization

Ethylene Oxide Sterilization, Revision of Annex E, Single Batch Release

EO Sterilization: Considerations for Neonate Products and Medical Devices and ISO 10993-7

Designing an End-to-End Sterility Assurance Program

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

Sterilization Dose Audits – The “Why” and the “How”

EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7

New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016

Best Practice Implementation of Parametric Release for EO Sterilization

Gamma: The Heart of Radiation Sterilization Past, Present and Future

PQ dose mapping and routine irradiation of products with non-uniform density distribution

Validating, Optimizing and Monitoring EO Sterilization Processes - Part 2

Product Adoption for Ethylene Oxide Sterilization

FAQs for Pet Treats Manufacturers: Get the Facts on Pathogen Reduction in Pet and Animal Nutrition

An Introduction to Radiation Dosimetry and the Mathmatical Model

Validating, Optimizing and Monitoring EO Sterilization Processes - Part 1

Pharma Packaging Considerations for Radiation Processing using Gamma and Electron Beam and Discussion on the New Container Closure Integrity Testing

Successfully Execute a Nitrogen Dioxide Sterilization Validation for a Drug in a Pre Filled Syringe

Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization

Three Methods to Establish the Sterilization Dose of a Medical Device

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

Footer Artwork