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...
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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...
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...
Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization
Medical device manufacturers using ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the...
Validating, Optimizing and Monitoring EO Sterilization Processes – Part 2
Establishing an Ethylene Oxide (EO) sterilization process involves navigating a complex path, as multiple factors influence the...
Validating, Optimizing and Monitoring EO Sterilization Processes – Part 1
Establishing an EO (ethylene oxide) sterilization process can be a complicated path as multiple factors play a...
Materials Qualification of Healthcare Products to Radiation Sterilization
Newer medical products, particularly those that are biological in nature or composed of materials sensitive to traditional...
A Review of Ionizing Radiation Sterilization Modalities
High-energy ionizing radiation is an established and proven method for sterilizing healthcare, food, and general industrial products....
Gamma: the heart of radiation sterilization past, present and future
The COVID-19 pandemic of 2020 highlighted the pivotal role of the medical device supply chain in delivering...
Material Consideration Radiation Processing
Each polymer reacts differently to ionizing radiation, making it crucial to verify that the maximum administered dose...