With over 35 years’ experience designing and manufacturing innovative packaging solutions for high brand impact products across multiple market sectors, CME Limited brought their expertise to bear in this project with the development of an automated packaging solution that conforms to medical and pharmaceutical standard 21 CFR Part 11.
A healthcare research and development company were bringing to market a completely new product and were looking for a company with assembly and packaging experience. CME was approached following a recommendation by an existing client due to their extensive experience in this field.
CME were briefed on the product which included its physical specification, process requirements and the need for the system to be pharmaceutically compliant for use within a clean room.
A suite of two machines were developed to meet the customers’ needs 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, labeling systems, laser coding systems and machine vision systems to check, inspect and verify both 2D matrix codes, colour’s and alphanumeric text in the form of a batch code and expiry date, as well as product integrity of the outer card sleeve alignment to the inner product body. The line continues by merging the products onto a single conveyor before passing through a single pack wrapper then on into a 10 pack collation system and bundle overwrap for transport.
CME Managing Director Paul Knight expands on the company’s involvement in the project: “We worked closely with all parties throughout this project to develop a solution which 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.”
CME’s rich history in developing innovative packaging solutions also positively influenced the design of the product blanks, modifying the profile to enhance the aesthetics of the folded product. The company’s Managing Director Paul Knight continues: “This is an excellent example of how CME is able to apply our design innovation and expertise to meet the diverse challenges presented to us from the market sectors which we serve. Our clients place great value on our capability to work in partnership with them from initial concept creation through to build, including systems integration and aftermarket support.”
The system is confirmed as consistently running at 95% efficiency and meets the pharmaceutical grade as specified by the client.