About this presentation:
Clinical-scale sterile filling lines lack acceptable sanitization processes for the introduction of tubs of Ready-to-Use (RTU) containers (vials, syringes, and cartridges). Electron beam sanitization systems are too costly and large; gaseous-based systems leave residues harmful to sensitive drug products, and flash-steam sterilizers are not developed enough for use. Instead, most small-scale filling lines rely on the aseptic technique, No-Touch-Transfer (NTT), to bring materials into the filling line which does not provide a positive decontamination of the materials.
Pulsed light technology (PLT) is a new and promising method to sanitize RTU containers in a robotic-based decontamination system. This technology provides a greater than 5-log reduction of resistant spores. It is rapid, non-polluting, leaves no residues, has a small footprint, and is economical. PLT has been used for years in the food industry for sanitizing containers, and the technology is just now making headway in pharmaceutical manufacturing.
This presentation will describe the technology, demonstrate how it is employed on a clinical-scale, sterile drug product filling line, and weigh the advantages and current limitations of the technology. The validation method, routine use, calibration, maintenance, and robustness of the system will be outlined, and the speakers will discuss future uses of PLT.
Learning Objectives:
The audience will learn:
- The different means used to transfer RTU containers and other materials into isolators.
- The mechanism of how pulsed light kills bacteria and spores.
- How to validate a pulsed light system for sanitization of surfaces.
- The benefits of PLT versus other technologies used to transfer materials into isolators.
- Future uses of PLT.
