"The software has been developed to adhere to CFR 21 Part 11 standards which is very important to us and to the industry as a whole."
Yann Deshayes, Quality Manager
Plastibell plants operate a large number of injection moulding machines that make hundreds of different types of parts for various medical devices, each part requiring a different moulding tool.
To guarantee consistent levels of quality and ensure compliance with CFR 21 Part 11 standards, whilst reducing costs, Plastibell Group needed to improve its tools management and the production of Certificates of Analysis.
Number of manufacturing plants installed: 3
Shopfloor-Online MES / MOM communicates with Plastibell's ERP from the moment a work order is downloaded and allocated to a machine.
The system's Tool Management module tracks when a job on a machine changes and ensures that the correct tools are used at all times.
Shopfloor-Online MES software manages the injection moulding tools and cavities; tool performance is tracked and a full audit trail of all actions for each cavity is created.
Quality checks of parts produced are carried out with CMMs and automatically recorded in the MES software; improving both traceability and efficiency.
Users are alerted to “out of specification" product.
Certificates of Analysis are automatically produced on completion of jobs.
Shopfloor-Online MES takes the data it receives from various sources to provide regular, accurate reports on progress. Plastibell benefits from greatly reduced manual data capture and consistent measurement and quality checks.
Tools management and quality management via Shopfloor-Online MES has resulted in:
Plastibell Group / DTP is a manufacturer of medical devices for leading health and pharmaceutical brands, from co-development, to prototyping and mass production (plastic moulding and injection moulding).