Optimizing Ethylene Oxide Sterilization: Sustainable Solutions for Pharmaceutical Packaging and Drug Delivery Devices
Ethylene oxide (EO) remains the sterilization method of choice for approximately 50% of all single-use medical devices...
Archives: Courses
Calculation of the Duration of Exposure and Associated Biological Effects for Biocompatibility Evaluation
In the biocompatibility assessment of medical devices, two of the primary points of consideration are how long...
End-to-End Human Factors for Medical Devices and Reprocessing Usability Testing
Human factors engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and...
Fundamentals of Disinfectant Efficacy
Disinfectants must be qualified on the surfaces present within a pharmaceutical manufacturing environment before they are approved...
Accelerating Product Release Through Patent-Pending RapidCert™ Biological Indicator (BI) Sterility Testing
RapidCert™ BI testing offers a transformative approach to biological indicator testing, delivering faster results than traditional compendial methods—incubation...
Reprocessing Considerations during Design Development for Reusable Medical Devices
Reusable medical devices are medical devices intended for repeated use on patients. These devices range from simple,...
Sterilization by Filtration: Validating Filtration for an Aseptic Process
This presentation explores the validation of sterilization by filtration as a critical step in aseptic pharmaceutical processing....
Applications Of Mathematical Modelling at Gamma Irradiator Sites
This will present two case studies of applications at customer sites to help the sites improve efficiency...
Growing Cobalt-60 Supply for a Sustainable Future
This review of the global Cobalt-60 supply chain is critical in understanding the current state and future...
A Dive into Disinfection Validations of Non-critical Devices
This discussion swims through topics related to disinfection validations of non-critical devices. Including selecting the appropriate level...
DAY 1 – Big Changes in Medical Device Biocompatibility: Updates Coming to ISO 10993-1
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
DAY 2 – Big Changes in Medical Device Biocompatibility: Updates to USP Class VI Impacting Medical Device Materials
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
DAY 3 – Big Changes in Medical Device Biocompatibility: How to Address These Updates for Existing Products and In-Process Submissions
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
Navigating the Decision Flow: Changing Sterilization Modalities for Medical Devices
As global regulatory pressures tighten and supply chain challenges increase, medical device manufacturers are increasingly considering changes...
Integrated Approach for Bulk Pharmaceutical Sterilization
Our popular Capsule Learning Webinars are back! All of the expertise of a webinar in 30 minutes...
Radiation Sterilization: What do product characteristics tell you about the type and source of radiation to use?
Since the installation of the first irradiators for the sterilization of single-use healthcare products in the 1960’s,...
Qualification of Primary Container/Closures for Parenteral and Ophthalmic Drug Products
This webinar provides a high-level introduction to Primary Packaging Qualification in the pharmaceutical industry. We take a...
Reprocessing Rethought: Effective cleaning and sterilization of robotic devices
One of the many advancements in the medical device industry has been the advent of reusable robotic...
Virtual Training Course – June 2025 – Introduction to Microbiology and Sterilization, Radiation Sterilization Methods, & Ethylene Oxide (EO) Sterilization
This course provides an introduction to principles of microbiology as it relates to terminal sterilization, radiation sterilization...
Microbiological Updates to 11137-1:2025 – Demonstrating Stability in Bioburden Numbers and Types
The previous version of ISO 11137-1 contained a requirement that manufacturers of products with low bioburden counts...