After an extended period of specification verification and project planning the latest Labman system build is underway for a UK manufacturer of medical test kits. The new system is the third generation of custom designed vial filling systems for this production process. The system is designed to fill, cap and then box 15,000 vials each day. As the product is a medical test kit, process validation is paramount; a number of automated validation steps assure product quality. Every vial assembled by the system has the cap torque checked and tightened to ensure vial integrity. Each box produced is photographed and archived for traceability. Future validation options include weighing of all dispensed liquids.
This is project week number 6 and the mechanical build is well underway. Major components are delivered and will be integrated over the next 4 weeks. After this time the electrical build will require a further 3 weeks before the system can undergo a formal functionality assessment. The successful completion of this assessment readies the system for software programming and the subsequent process and performance testing. As always the process is closely managed by Labman’s QA programme which follows the validation methods defined by GAMP 5 (Good Automation Manufacturing Practice, http://www.ispe.org).
The project is planned for delivery and commissioning in quarter 3 2013.