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)...
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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...
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...
Three Methods to Establish the Sterilization Dose of a Medical Device
In the medical device industry, sterilization processing is performed to obtain a Sterility Assurance Level (SAL) as...