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Environmental Compliance and Control for Radiopharmaceutical Production
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Ching-Hung Chiu, Ya-Yao Huang, Wen-Yi Chang, Jacek Koziorowski
Bioburden [24] is used to describe the microbial numbers on a surface or inside a device or from a portion of liquid. In some literature, bioburden testing relates to raw materials testing, environmental monitoring, or in-process sample testing. These areas will have a given, even ‘natural’ bioburden. When this bioburden rises above typical levels or ends up in the wrong place, it becomes biocontamination [25].
Prevention of Microbial Contamination during Manufacturing
Published in Philip A. Geis, Cosmetic Microbiology, 2020
The source of a microbial bioburden from a manufacturing facility in a non-sterile product formulation could be one or all of the following: facility itself, manufacturing systems, equipment, and cleaning/sanitization processes.
Considerations for Clinical Trials Involving Microneedle Devices
Published in Boris Stoeber, Raja K Sivamani, Howard I. Maibach, Microneedling in Clinical Practice, 2020
Nonetheless, the small, shallow breaches from microneedles have been shown to pose low practical risk of infection (26). Manufacturers should assess risk to determine what level of bioburden control is appropriate for the clinical stage of development.
Enhanced skin drug delivery using dissolving microneedles: a potential approach for the management of skin disorders
Published in Expert Opinion on Drug Delivery, 2023
Sakshi Priya, Yashika Tomar, Vaibhavi Meghraj Desai, Gautam Singhvi
Considering the commercialization aspect, the requirement of sterilization must be taken into consideration during early development. Even though there is a low risk of bioburden in introduction through the skin, the regulatory requirements may make sterilization obligatory to ensure user safety [20]. In a study by Garcia et al., self-sterilizing MNs were introduced with the claim that until the skin heals entirely, the skin pores caused by MNs shall remain free from infection [123]. The knowledge and available literature are limited in this aspect and need utmost attention. There are also limitations in economic evaluation of MNs technology since it is obvious to predict that the cost associated is very high owing to complex manufacturing, evaluation, and storage procedures along with slow and delayed approval process. Even though the technology exhibits great potential in MNs treatment, its economic assessment is equally important for successful commercialization [20]. The upcoming novel techniques for fabrication like 3D printing and micromachining are foreseen to reduce cost and improve quality.
The Impact of a Novel Operational Readiness Response Model on the Environmental Cleanliness of Emergency Ambulances
Published in Prehospital Emergency Care, 2022
David Morris, Giuseppe Fierravanti, Adam Schrieber, Sarah Johnson, Damien Bartolo, Kate Hipsley, Tanya Somani, Robin Pap, Kingsley Agho, Liz Thyer, Paul M. Simpson
Important to the argument that a dedicated cleaning service such as that contained within the MRM is feasible and worthwhile is consideration of the magnitude of effect and the model of implementation. The MRM described herein is part of a larger operational response model initiative designed to transform the operational, logistical and business processes associated with asset readiness and maintenance; improved ambulance cleanliness via a dedicated non-clinical cleaning crew is one component within that broader model. Implementation of an MRM-style dedicated cleaning system in the absence of it being part of a broader operational project may impact on feasibility despite the apparent infection control benefits associated with it. Further to this, the magnitude of effect in terms of bioburden reduction needs to be considered. The present study reported a 38% reduction in overall bioburden, but it is unclear whether this magnitude of reduction is large enough to satisfy health economic arguments.
The potential role of using vaccine patches to induce immunity: platform and pathways to innovation and commercialization
Published in Expert Review of Vaccines, 2020
Kamran Badizadegan, James L. Goodson, Paul A. Rota, Kimberly M. Thompson
Vaccine patches will require high-quality, cost-effective, and reliable processing under good manufacturing practice (GMP) conditions. Vaccines are highly regulated given their use in healthy children, which will imply significant investments of regulatory compliance costs. In addition, significant uncertainty remains about the need for sterile vs. low bioburden production, and the processes regulatory authorities will find acceptable [20,139,140,179]. Low bioburden production means not requiring sterility for vaccine patches (due to their administration of vaccine to non-sterile skin) but would limit any organisms in the final product to very low levels. Low bioburden production would save significantly on production costs, because sterile production processes require isolators and other costly equipment. Production and design choices will determine the cost of vaccine patches, and thus the cost premium relative to existing syringe and needle or other presentations for existing vaccines.