Purchasing an aseptic filling line can provide a huge economic advantage to a pharmaceutical company looking to increase its scale and throughput. An aseptic filling line can reliably increase production capacity, standardize quality, and reduce operator labor by combining multiple processes into an integrated system. Unfortunately, many companies don’t accurately estimate the level of effort needed to effectively engineer, procure, install, startup, troubleshoot, commission, qualify, and validate aseptic fill lines to get these systems to a level of high operating efficiency and profitability.
Often, skilled technical resources and expertise are not available to advance these complex systems through factory and site acceptance tests, recipe configurations, and installation operation, and performance qualifications. Timelines slip and costs accumulate due to lack of technical and mechanical aptitude, poor planning, and misunderstanding of what is necessary to get complex customizable systems operational in a regulated environment.
Kymanox has specific expertise in commissioning, qualification, and technical project management for aseptic fill line installations. Our technical knowledge has successfully helped companies challenged with qualifying and validating their aseptic fill lines.