March 9, 2023
Aseptic Filling of Small Volumes at High Precision
Filling accuracy has become increasingly important for laboratories and biopharmaceutical manufacturers. Single Use Support has developed best-in-class filling precision for aliquoting small single-use bags with its RoSS.FILL Lab Scale aseptic filling platform.
Typically, the distribution of small volumes of advanced therapy medicinal products (ATMP) into small single-use bags was done manually. However, manual handling carries the risk of crosscontamination, overfilling, inconsistent cell counts, and, as a result, product loss. RoSS.FILL Lab Scale is a fully automated cGMP-compliant aseptic filling technology for up to 12 small single-use bags of 10mL to 500mL. The single-use technology optimizes bag filling with fast, scalable, and accurate aliquoting. The lab-scale version of Single Use Support’s small volume filling line is specifically designed to support laboratories and biotechnology companies manufacturing cell and gene therapy applications to advance fluid management processes through automation.
High Precision Filling
Single Use Support offers best-in-class fluid management solutions for volumes as little as 1mL. With a filling accuracy of ±5% for volumes ranging from 20mL to 50mL and a filling accuracy of ±2% from 50mL upwards, the globally operating process solution provider enters new realms of automated filling accuracy for biopharmaceuticals. By complying with 21 CFR Part 11, the automated aliquoting system for single-use bags replaces manual documentation.
Advanced sealer pinch valves can be optionally integrated into any of the modular RoSS.FILL platforms. With variable fluid control to accelerate throughput and facilitate fast filling as well as simple aseptic decoupling of single-use bags, these valves significantly improve the fluid management process. Single Use Support’s modular and vendor-independent process solutions for sterile
filling–draining, freezing–thawing in addition to their protective solutions that cover the entire storage and shipment process further optimize the fluid management of high-value liquid drug substances.