The responsibility of ensuring these requirements is entrusted to a little-known professional known as a sterile processing technician. In this presentation, my aim is to acquaint you with this occupation and potentially persuade you to pursue a career as a sterile processing technician in Kentucky....
Among the significant innovations in sterile drug manufacturing has been the adoption ofsingle-use technologies(SUTs) to replace conventional reusable stainless-steel vessels and processing lines. Single-use systems, including disposable bags, filters, tubing, and connectors, have gaine...
CTM projects inherently contain many variables, must be synchronized with the start of a clinical study, and have specific packaging and labeling requirements, in addition to all the other standard GMP manufacturing requirements. Any delays or an inability on the part of the manufacturer of clinical...
BS EN 556-1-2024 Sterilization of medical devices — Requirements for medical devices to be designated STERILE Part 1: Requirements for terminally sterilized medical devices 医疗器械的消毒ーー医疗器械标识为无菌的要求第1部分: 终端消毒医疗器械的要求.pdf,B
The U.S. Food and Drug Administration (FDA) likewise has mandated requirements, in particular on bioburden: “Knowledge of the bioburden is important in assessing whether a sterilization process is adequate.” (Sterile Drug Products Produced by Aseptic Processing)....
Testing Requirements for Sterile Barrier Packaging and DevicesWatch Webinar In this webinar, originally broadcast as part of the Pharmapack Europe show, speakers from STERIS will discuss: Transportation testing accelerated aging and package integrity testing overview How to construct a packaging ...
The U.S. Food and Drug Administration (FDA) likewise has mandated requirements, in particular on bioburden: “Knowledge of the bioburden is important in assessing whether a sterilization process is adequate.” (Sterile Drug Products Produced by Aseptic Processing)....