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...
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The Big Three: Cytotoxicity, Sensitization & Irritation Testing
Among the myriad of tests that medical device manufacturers must conduct, none are more critical than the...
Successfully Execute a Nitrogen Dioxide Sterilization Validation for a Drug in a Pre-Filled Syringe
Biotech drugs are currently the fastest growing segment within pharmaceutical and biotech pipelines, with approximately 60-70% of...
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...
PQ dose mapping and routine irradiation of products with non-uniform density distribution
Operational Qualification (OQ) dose mapping of gamma irradiators typically involves using homogeneous materials. However, the real-world scenario...
Best Practices When Validating Reusable Devices
The advancement of reusable medical devices has significantly transformed the medical device industry, bringing about changes in...
Cobalt-60: The Heart of Radiation Sterilization
For over 50 years, Cobalt-60 has served as a crucial source of gamma radiation, extensively used for...
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...