A healthcare research and development company, bringing to market a completely new product, was looking for a company with both assembly and packaging experience. CME’s expertise in these fields led to a recommendation by an existing client, with CME subsequently being briefed on the product, its physical specification, process requirements and the need for the system to be pharmaceutically compliant for operation within a clean room.
A suite of two machines, developed to meet the customer's needs, and capable of producing a total of 120 parts per minute, accept finished assembled product from their respective input conveyors.
The individual technologies were designed specifically to suit the process and integrate within the machines. The line includes hot melt glue applicators, labelling systems, laser coding systems and machine vision systems. These are used to check, inspect and verify both 2D matrix codes, colours and alphanumeric text, in the form of a batch code and expiry date, in addition to checking product integrity of the outer card sleeve alignment to the inner product body. The line continues by merging the products onto a single conveyor, prior to passing through a single pack wrapper, and then on to a 10 pack collation system and bundle overwrap for transport.
CME managing director Paul Knight says: “We worked closely with all parties throughout this project to develop a solution that adheres to the strict medical and pharmaceutical compliance standards required for 21 CFR Part 11. The machines, which incorporate the necessary features for the standard such as dual logon digital signatures, password management and audit trails, check that the correct product is being produced, prior to verifying, reconciling and recording data at each stage. Any rejected items pass through the system with no further added value operations, before being subsequently segregated. The systems also undergo “Challenge Checks” prior to each production batch to ensure that defects are positively identified by the machine vision systems.”
The system is confirmed as consistently running at 95% efficiency, and meets the pharmaceutical grade specified by the client.