LVP Polyolefin Solutions Addressing Different Packaging and Regulatory Requirements
Large Volume Parenterals (LVPs) can be packaged in a variety of formats made from polyolefins, including pouches,...
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Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18
All medical devices that are intended to contact patients or medical personnel (directly or indirectly) require an...
Primary and Secondary Packaging Materials as Potential Source of Nitrosamines
Recently, several drug product recalls have occurred due to the unexpected presence of N-Nitrosamines. While the formation...
Risk Assessment for Potential Elemental Impurities on Drug Products and Medical Devices
When submitting drug products for approval, regulatory authorities frequently ask, “Are you submitting your risk assessment for...
The Big Three: Cytotoxicity, Sensitization & Irritation Testing
Among the myriad of tests that medical device manufacturers must conduct, none are more critical than the...
Packaging Validation 101
Have you ever wondered how to set up a packaging validation according to ISO 11607? Join us...
Hunt for N-nitrosamines in Medicinal Products
In the EMA newsletter published in September 2019, the pharmaceutical industry received a significant wake-up call regarding...
The Testing and Risk Management Impacts of Changing a Medical Device
Throughout its product life cycle, a medical device and its support system can undergo numerous changes—sometimes even...
Best Practices When Validating Reusable Devices
The advancement of reusable medical devices has significantly transformed the medical device industry, bringing about changes in...
Impact of MDR on Biocompatibility, a Shortage of Expertise
As the deadline for the Medical Device Regulation (MDR) approaches, many medical device manufacturers are rushing to...