Container Closure Requirements: Preparing for USP
Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the...
Archives: Courses
Single Use Endoscopes Critical Safety and Regulatoy Considerations for Manufacturers
The transmission of infections via endoscopy remains a critical concern due to the inherent design challenges of...
Implementing Parametric Release for EO Sterilization
Join us for an informative webinar that reviews the benefits of parametric release and how to establish...
The Impact of Sterilization Modality on Connected Devices with Electronic Components
devices. The complex nature of connected devices, which often involve a combination of materials and electronic components, can...
The Transfer of Medical Device and Pharmaceutical Products between Radiation Sterilization Modalities
With the growing demand for sterilization of medical devices and pharmaceutical products, the industry is increasingly looking...
2023 AAMI Biological Evaluation Standards week meetings
Join us for an engaging podcast featuring business leaders from Nelson Labs who have just returned from...
GMED- Materials & Packaging for Terminally Sterilized Medical Devices
Join us for an insightful session that covers the essential aspects of packaging, focusing on both basic...
Container Closure Integrity Testing for Pharmaceutical Sterile Barrier Packaging
Container Closure Integrity Testing (CCIT) is crucial for evaluating the sterile barrier integrity of pharmaceutical packaging, including...
Cobalt-60 Investing for the future of Gamma Sterilization
Gamma sterilization has been the predominant radiation sterilization modality for decades, accounting for more than 30% of...
Bioburden Testing and Microorganism Characterisization: Enhanced Guidance for Low Sterilization Dose Products
In recent years, concerns have been raised regarding the lack of understanding of bioburden (both numbers and...
Understanding Radiation Methods of Dose Establishments and Importance of Sterilization Dose Audits
Join us for this popular webinar as we delve into the various methods used to establish the...
Introduction to Industrial Sterilization
Join us for an insightful presentation featuring expert advisors Erik Hagedooren, Senior Director of New Sterilization Technologies,...
2023 Spring AAMI Standards Week Update
In this podcast from Nelson Labs, business leaders who recently returned from the AAMI standards week meetings...
Introduction to Microbiology and Sterilization
Are you looking for foundational knowledge on microbiology as it relates to sterilization services and testing? Watch...
Removing rabbits from irritation testing: Current status of regulatory acceptance of ISO 10993-23
In recent years, significant changes have been made to the standards and practices surrounding biocompatibility testing, driven...
Skin Care Products Understanding Clinical Testing Options
Skin-care products have become an essential part of the cosmetic and personal-care industry. Whether you are dealing...
Is it time to Re-Evaluate your Design History File for Reusable Device Validations
Standards for reprocessing have become a top priority for regulatory bodies worldwide. The active work around reusable...
Guidance on Combining Biocompatibility and Cleaning Validation Testing
Testing all biocompatibility endpoints for reusable medical devices both at first-time use and after multiple reprocessing cycles...
The Biocomp Trail A Challenging hike towards Animal Free Testing
The main purpose of ISO 10993-1 is to emphasize a risk-based approach for evaluating the biocompatibility of...
Appropriate uses for Product Sterility Testing When is Sterility testing appropriate
Sterility testing is often the first test that comes to mind when determining if something is “sterile.”...