High containment and reduced cleaning results in quick and effective campaign changes
CMO and CDMO facilities have experienced fast paced growth and with more potent compounds planned for launch in the future the good times will continue. There are unique problems with growth for these contract facilities and many have to do with the controls required to assure proper containment of compounds in a multi-use facility. Containment is critical to assure personnel are not exposed to the affects of the drugs and to mitigate issues with cross contamination. These additional controls require greater attention to SOP’s particularly for cleaning and validation. These cleaning procedures reduce the uptime of equipment or process suites then limiting the facility to take on more campaigns and grow faster. This is where single use containment can expedite the changeover in campaigns while still providing the needed controls.
The webinar will present a full range of solutions in applying single use containment to process equipment and focus on the performance, cost savings, and changeover speed of the equipment and suites. Beginning with the typical issue facing the CDMO facility that often campaigns are handled before the early clinical studies are done. These means little toxicology information is available and so they have to be conservative and default to higher level of engineering controls. Processes that were once thought to be safe with simple LEV or no controls now have to be contained. Scaling up to production and CMO’s the game is to utilize the equipment as much as possible. They cannot afford to have containment excursions which create further risks and take additional time to handle. The containment systems chosen must perform and they must allow for ergonomic handling as well as fast cleaning. Single use systems contain at the source protecting the suite from contamination as well as protecting operators. This is key to high utilization rates of the facility and confidence for management to take on more projects.
The information will allow these processors to effectively make decisions to choose the right solution for containment meeting the technical and commercial requirements and maintaining the planned growth for contract manufacturers.
Scott Patterson, VP of Commercial Sales
Scott Patterson is a subject matter expert for containment of pharmaceutical manufacturing processes as well as powder handling in upstream biopharmaceutical manufacturing. He has been supporting the global marketplace with ILC Dover for the past 14 years and has a total of 21 years of experience in the life sciences market. He has led innovative advancements using single use products to demonstrate the performance capabilities and value proposition. With a mechanical engineering education at Youngstown State University he is now starting year 41 of experience in a wide range of markets including plastics, pulp and paper, packaging and inspection equipment, as well as expertise in milling and roller compaction.
Key Learning Objectives
- Single use flexible containment systems achieve nanogram level containment
- Single use systems are robust but should be changed out instead of cleaning
- Contain at the source and mitigate risks of cross contamination
- Single use flexible containment speeds up campaign change over and while saving money
- Project Engineer
- Process Engineer
- Plant Manager
- Director of Manufacturing
- Director of EH&S
- IH Manager
- Director of Quality Control
- Director of R&D
- Research Scientist