Background As an agricultural product, cannabis can be exposed to contamination with pathogenic fungi, bacteria, yeast, and mold during growing, drying, packaging, and/or delivery, which may put consumers at health risks. For example, fatal pulmonary Aspergillosis has been reported in some users, especially immune-compromised patients, who were treated with and/or were using inhaled cannabis products.…
Q1: What is the Radiation Sterilization Master File Pilot Program? A:The Radiation Sterilization Master File Pilot Program (Pilot Program) is a voluntary program that intends to allow companies that terminally sterilize single-use medical devices using gamma radiation or ethylene oxide (EO) to submit Master File(s) when making certain changes to sterilization sites, changes to sterilization…
Background A verification (dose audit) or sterilization dose experiment requires a narrow and specific dose range to be applied to the samples used for tests of sterility as evidence that the routine minimum dose remains appropriate for delivering the require sterility assurance level. Dose requirements for radiation processing are defined in ISO 11137 part 2…
Industrial radiation facilities are designed to achieve a dose uniformity inside a process load between the sterilization (minimum) dose and the maximal acceptable dose established during the validation process. To demonstrate continued effectiveness of the established sterilization dose, a dose audit is required to be performed at defined frequencies. This audit requires the treatment of…
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This TechTip will explain the differences between single lot validations and full validations of minimum sterilization dose, and outline the advantages and disadvantages of each of these approaches to dose setting.
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