Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization
Medical device manufacturers using ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the...
Archives: Courses
Thermal Disinfection & Steam Sterilization Validation for Reusable Devices
Join hosts Jason Pope and Lise Vanderkelen in this informative webinar that will delve into the essential...
Evaluating the biocompatibility of reusable medical devices during their whole life cycle
In the past, the primary focus for reusable medical devices was on validating reprocessing efficacy with regard...
An introduction to large volume parenterals (LVPs) as a pharmaceutical dosage form
Pharmaceutical dosage forms are primarily distinguished by their route of administration, with secondary differentiation based on other...
Challenges and Considerations for Complex LVP Drug Products
Addressing the toxicological risks associated with patient exposure to leachables requires a strategy tailored to the unique...
The Production Process and Qualification of a Pharmaceutical Film
What is required to qualify primary packaging materials for Large Volume Parenterals (LVPs)? What factors should be...
Decontamination, Sterile Processing, and Performance Testing of Personal Protective Equipment (PPE)
During the COVID-19 pandemic, the demand for personal protective equipment (PPE), especially medical face masks and respirators,...
MDR with Brexit_ How the Combination is Impacting the European Medical Device Industry
With the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) was delayed by one year....
Requirements and Impact of the New Guideline – ISO 10993-23: Tests for Irritation
The landscape of biocompatibility testing for medical devices is evolving with the recent shift of irritation assessment...
Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial
This is a crash course overview of medical device biocompatibility, designed to provide a comprehensive understanding of...
Validating, Optimizing and Monitoring EO Sterilization Processes – Part 2
Establishing an Ethylene Oxide (EO) sterilization process involves navigating a complex path, as multiple factors influence the...
Container Closure Integrity and Stability Testing for Rigid Containers
Setting up a stability test plan for vial products can be a daunting task with many variables...
Validating, Optimizing and Monitoring EO Sterilization Processes – Part 1
Establishing an EO (ethylene oxide) sterilization process can be a complicated path as multiple factors play a...
Effective Auditing for Manufacturing Quality
Gain confidence that your product meets the necessary quality standards and ensure compliance with the guidance of...
Future Trends To Control Risks From Extractables and Leachables
Prior to 2018, ophthalmic drug products (ODPs) and parenteral drug products (PDPs) underwent similar processes for Extractables...
The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
A Delay in MDR? Where are we now?
With the onset of the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) has been...
Data Integrity and Quality Culture During the Pandemic
In this episode, host Brandon Miller is joined by Steven Lynn, Executive Vice President of Pharmaceuticals at...
Cleaning Validations for Reusable Devices A Road Trip to the EU and US Market
Reprocessing validations for reusable medical devices have often been neglected, but recent regulatory developments have brought their...
An Outline of Current Medical Face Mask Performance Requirements and Testing
The current pandemic has brought medical face masks and respirators into the spotlight, highlighting the critical need...