Monitoring of Delivered Dose Using Reference Dosimetry
Monitoring of the minimum delivered dose position for healthcare products is required per industry standards (i.e. ANSI/AAMI/ISO 11137)
Monitoring of the minimum delivered dose position for healthcare products is required per industry standards (i.e. ANSI/AAMI/ISO 11137)
Selection of the dose setting method depends on the bioburden of the product & the maximum dose at which the product can retain its form, fit & functionality
In the case of a dose audit failure, a complete failure investigation should be conducted to determine the cause of failure. This TechTip covers considerations after experiencing a dose audit failure
Significant figures are numbers that carry a contribution to a measurement and are useful as a rough method to round a final calculation. For more complex systems such as the uncertainty of a dosimetry system, or estimating the bioburden of a product, more accurate methods should be used
The Radiation Technology Center (RTC) specializes in handling products requiring high precision irradiation dose delivery for validation, dose audit and research purposes. To help facilitate product submissions and improve product turn time this TechTip addresses questions that may arise when product is submitted for irradiation processing.
This TechTip compares various attributes of the Alanine and Red 4034 dosimetry systems
This TechTip looks at issues that must be considered when irradiating APIs and pharmaceutical fillers, benefits of terminal sterilization, characteristics that lead to successful sterilization, areas that incite concern or special care in designing a sterilization plan and tools to improve success rates
This TechTip discusses the overall requirements, use of surrogate materials and application of reference dosimetry during routine gamma irradiation
This TechTip focuses on what Customers need to know before initiating changes to product packaging in order to ensure that the efficiency and effectiveness of the gamma process is maintained
This TechTip reviews dose auditing, while a companion document will look at dose setting in this same format