Issue link: https://www.e-digitaleditions.com/i/446555
Tablets & Capsules January 2015 61 Our tablet contract manufacturing facility reached out to Techceuticals LLC for assistance with tablet hardness and disintegration problems. We received a thorough review, solid guidance, technical assistance beyond our in-house capabilities, and a solution. Mike Tousey Technical Director, and CEO of Techceuticals answered our call. We explained to Mike that we had a very complex formula, and our client needed us to fast track a solution to meet their supply demands. Mike interviewed our team, and helped us assess and identify multiple root causes. Mike first explained that he wanted to categorize potential solutions into four categories - the tablet press, tooling, formulation, and the environment, and suggested the following: The Tablet press Make sure the scraper blade is in good condition. Decrease punch penetration to help release the air during the compression process. Determine if reducing speed would improve weight accuracy, and if the extended dwell time would impact hardness. We learned to setup the machine, and use one side as pre-compression. Mini Case History Tooling Verify working length of the tooling is within tolerance. Verify the head flats on the tooling are uniform. Inspect the dies for wear rings, and verify a tapered die is being used. Formulation Review component particle size distribution, and bulk density. Identify significant morphology differences. Review batch records, order of addition, and screening procedures. Review process machine's steps required for proper setup and operation. Environment: Verify that storage conditions of raw materials are compliant for each component. Make certain process path and staging is closely controlled. Verify hold times are consistent. The project approach resulted in my team receiving excellent training throughout the process. There were reasons, and explanations for each action, and the result is I now have a team that is better prepared for identifying root cause in a clear and concise way. Our next step? To go to Cleveland to Mike's pilot facility to work on our formulas, and train our team. SIGNED: Satisfied Customer!