Tools of the Trade Ways to make EO Processing more Efficient
Ethylene Oxide (EO) sterilization is one of the most complex sterilization methods commonly used, with numerous approaches...
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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...
The Road to Market Authorization for Sterile Medical Devices within the European Union
Sterile medical devices must adhere to the regulations and standards for CE marking that came into effect...
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...
Sterility, Manufacturing and Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals
The biopharmaceutical sector is experiencing rapid changes, transitioning from monoclonal antibodies to advanced therapies such as Cell...
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...