DISINFECTION VALIDATION: How to Classify and Validate Your Medical Device Disinfection Process
Reprocessing reusable medical devices involves cleaning, disinfecting, and sterilizing them to ensure they are safe and effective...
Browse Content
Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
Establishing Bioburden Alert and Action Levels
In the realm of bioburden, sterilization, and environmental testing, national and international standards play a crucial role...
Meeting the Requirements of 10.4 of MDR How to Address CMRs
Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the...
Microbiological Control in a Pharmaceutical Manufacturing Environment
This webinar will focus on the evaluation of microbiological and environmental monitoring data, highlighting what constitutes significant...
Considerations for Third Party Reprocessing of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by third-party reprocessors can enable healthcare providers to maintain...
MPO Packaging Validations – A Look at Current and Future State Testing
This webinar will explore the significant changes implemented with the release of the Medical Device Regulation (MDR)...
Guidance for Cleaning, Disinfection and Sterilization of Reusable Medical Devices
All reusable medical devices must include specific instructions for cleaning, disinfecting, and/or sterilization to ensure patient safety...
Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18
The final draft revision of part 18 of the ISO 10993 series, now titled “Chemical Characterization of...