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
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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The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list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
Best Practice Implementation of Parametric Release for EO Sterilization
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”
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
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
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
