Product Adoption for Ethylene Oxide Sterilization
Changes to the design of an existing product or the adoption of a new product into a...
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Product Safety Future State of Sterility Assurance and the Role of Terminal Sterilization
Sterilization is a critical step in the pharmaceutical drug development process to ensure overall safety. Regulations are...
EO Sterilization: Considerations for Neonate Products and Medical Devices & ISO 10993-7
Ethylene oxide (EO) sterilized items are life-saving and critical devices that undergo sterilization in highly regulated environments,...
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...
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...