Non-Sterile Gloves as a Source of Radiation-Tolerant Microorganisms.

Radiation methods are widely used for disinfection and sterilization applications. Microorganisms demonstrate known, variable tolerance levels to inactivation with lower doses of ionizing and non-ionizing radiation based on multiple mechanisms of resistance in their structures and nucleic acid repair mechanisms. The radiation dose required to ensure microbial inactivation during sterilization is typically based on the understanding and routine monitoring of the natural population and resistance of microorganisms on products exposed to radiation sterilization processes. This report describes the isolation of Roseomonas mucosa in a device manufacturing environment that was detected during routine device bioburden and dose verification monitoring. Sources of Gram-negative bacteria in the environment were investigated. Non-sterile examination gloves used during manufacturing were found to be a persistent source of R. mucosa and other microbial contaminants. The source of contamination was determined to be from the glove manufacturing process. Maintenance and routine microbiological controls during glove manufacturing, including water systems, are required to reduce the risks of gloves being a source of unexpected microbiological contamination.

Regulatory Approach for Transitioning from Gamma Ray to X-ray Radiation Sterilization.

When investing in X-ray irradiation facilities around the world, an opportunity exists for defining a regulatory framework for assessing the transition from current gamma irradiation processes. Historically, regulatory strategies for changing the radiation source for routine processing has consisted of repeating the majority, if not all, of the validation activities performed as part of an initial validation and associated submission. Although not a new concept, performing a risk assessment has the potential to be leveraged more fully by increasing the rigor of determining what is changing when product moves from a gamma to an X-ray irradiator, then determining how these differences may affect product characteristics. During these steps, differences can be identified and quantified between radiation sources and potential impacts, if any, to product quality can be elucidated. Based on these risk assessments, the level of action required, or not required, in terms of empirical product testing can be examined and a determination can be made regarding whether a substantial change has occurred.