Medical Packaging and the Impact of NO2 Sterilization
Novel sterilization modalities are becoming increasingly prevalent in the healthcare industry, offering new solutions for ensuring the...
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Radiation Sterilization of SVPP: RTU and fill/finished. Do not default to 25 kGy – 40 kGy.
At the 2022 Nelson Labs Virtual Symposium, we will present examples of radiation sterilization for Ready-to-Use (RTU)...
Product Adoption for Ethylene Oxide Sterilization
Changes to the design of an existing product or the adoption of a new product into a...
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...