Barrier isolator technologies have made significant contributions to the advancement of aseptic processing and the increased level of sterility assurance. This article discusses why this is so and provides brief information about types of isolators, isolator attributes, isolator challenges, and considerations in isolator design, implementation, and validation.
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PDA J Pharm Sci Technol
October 2024
Analytical Science Laboratory, Development Service, Vetter Pharma-Fertigung GmbH & Co. KG, Schuetzenstrasse 87, 88212 Ravensburg, Germany.
For clean-room technologies such as isolators and restricted access barrier systems (RABS), decontamination using hydrogen peroxide (HO) is increasingly attractive to fulfill regulatory requirements. Several approaches are currently used, ranging from manual wipe disinfection to vapor phase hydrogen peroxide (VPHP) or automated nebulization sanitization. Although the residual airborne HO concentration can be easily monitored, detection of trace HO residues in filled products is rather challenging.
View Article and Find Full Text PDFClin Exp Emerg Med
March 2024
Department of Emergency Medicine, Yonsei University College of Medicine, Seoul, Korea.
Objective: The efficacy of previously developed respiratory barrier enclosures to limit healthcare workers' exposure to aerosols from COVID-19 patients remains unclear; in addition, the design of these devices is unsuitable for transportation or other emergency procedures. Therefore, we developed a novel negative pressure respiratory isolator to improve protection from patient-generated aerosols and evaluated its protective effect in conversion to systemic isolator.
Methods: This in vitro study simulated droplets by nebulizing 1% glycerol + 99% ethanol solution.
Adv Mater
January 2023
Department of Materials Science, Fudan University, Shanghai, 200433, China.
The lack of safe and efficient hydrogen storage is a major bottleneck for large-scale application of hydrogen energy. Reversible hydrogen storage of light-weight metal hydrides with high theoretical gravimetric and volumetric hydrogen density is one ideal solution but requires extremely high operating temperature with large energy input. Herein, taking MgH as an example, a concept is demonstrated to achieve solar-driven reversible hydrogen storage of metal hydrides via coupling the photothermal effect and catalytic role of Cu nanoparticles uniformly distributed on the surface of MXene nanosheets (Cu@MXene).
View Article and Find Full Text PDFAAPS PharmSciTech
August 2022
Cytiva, 4560 Tillicum St., Burnaby, British Columbia, V5J 5L4, Canada.
The human operator is acknowledged as the greatest potential source of contamination in aseptic processing. To avoid contamination, barrier systems have progressively reduced the amount of human intervention in the critical zone. This study extends the trajectory of enhanced patient safety through the elimination of human intervention in aseptic filling.
View Article and Find Full Text PDFAnim Nutr
June 2021
Key Laboratory of Animal Disease-Resistance Nutrition, Chengdu, Sichuan 611130, China.
This study was conducted to investigate host-microbiota interactions and explore the effects of maternal gut microbiota transplantation on the growth and intestinal functions of newborns in a germ-free (GF) pig model. Twelve hysterectomy-derived GF Bama piglets were reared in 6 sterile isolators. Among them, 6 were considered as the GF group, and the other 6 were orally inoculated with healthy sow fecal suspension as fecal microbiota transplanted (FMT) group.
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