Applying Single Use Systems for Cost and Ergo Benefits

The growth of lyophilization processes has challenged manufacturers to maintain safety for operators working with highly potent ingredients and to assure product quality and protection from contamination. Ranging from very small lyo systems used for product development to larger production systems, the ability to handle vials and trays is often an ergonomic exercise as well as the risks associated with exposure and potential product loss. Traditional solutions using RABS and hard wall isolators are very costly and require multiple operators to work together moving trays often in awkward motions. These problems are addressed with single use containment making it easy to retrofit isolation to existing equipment.

Single use or flexible isolation technology has been proven throughout the pharmaceutical and biopharma spaces and can be easily applied to lyophilization. Many customers have hesitated to apply isolation technology and continued to use PPE solutions. The PPE solutions are really a last resort in the safety hierarchy. Having the ability to use single use isolation as the engineering control brings the process in line with best in class manufacturing.

As in most processes, there is not a single design to fit all lyo processes. Ranging from the small discovery lyo systems to larger units for development and clinical supply requirements and finally full-size production systems, the isolators must accommodate a range of needs. In addition to the loading and unloading of a lyo system with the vials and trays, the system must consider upset events like broken vials. In a perfect world this would not happen, but the reality is that vials can tip over and stoppers can be misplaced. This will significantly increase the risk of exposure and require a clean-up process. The features that are included with single use isolation are meant to assure containment even in an upset condition.

The webinar will present actual solutions that have been used for lyophilization containment as well as other processes to show the great depth of experience and performance that is associated with single use systems. Typical projects costs are estimated and compared to the more costly traditional systems to show the complete value proposition of using the ILC Dover systems.