Solution: Bottle Packaging Line
Clarke Solutions designed, managed, installed, commissioned and qualified a bottle packaging line off site in its Fishers, Ind., facility. The project was completed off site for the client to allow the existing line to remain running while the new line was being developed and qualified. After the project began, Clarke Solutions learned that the pharmaceutical company it was working with received a priority review on its new drug application. Due to an expedited schedule, Clarke Solutions worked closely with the OEMs to expedite equipment. Clarke Solutions set up a two-shift operation and cut nearly three months off the original schedule. Clarke Solutions managed the installation and start up of the equipment and resolved issues on a timely basis. Clarke Solutions wrote the validation documents and executed the qualification of the equipment at the same time the company trained employees who would eventually operate the equipment. Clarke Solutions delivered the equipment ahead of the expedited schedule. When the existing line was finally shut down, the down time on the new line was reduced by more than 50 percent to 32 days due to the upfront work done at Clarke Solutions.
Solution: Serialization System
Clarke Solutions designed, managed, installed, commissioned and qualified a pilot line to develop a serialization system to meet the requirements of upcoming e-pedigree regulations. Clarke Solutions developed a line that was flexible to run cartons or bottles and capable of different levels of serialization, from authentication through a complete track and trace system where unit level items were aggregated to cases and cases were aggregated to pallets. Clarke Solutions managed the vendor selection process and worked closely with the company to integrate the serialization solution on the packaging line.
Solution: On-Site Thermoformer Line Development
Clarke Solutions managed the utilities, installation, start up and debug of four high-tech thermoformer lines at a client’s facility. Clarke Solutions designed the utilities and established primary room and secondary room conditions, designing a detailed installation plan and requesting competitive bids. Clarke Solutions managed the electrical, mechanical and rigging contractors, saving the client substantial time and money, and managed the OEMs and the start up of the lines. Clarke Solutions also led the daily operations to get these new lines up and running by identifying issues as they arose and developing action plans to resolve issues.