The Challenge
Harmac were contracted by an existing customer to design and build a new medical device kit manufacturing process. The end customer’s requirement included a digital manufacturing traceability system as part of the overall solution. Harmac were looking to partner with a System Integrator to design and build a system capable of tracking, tracing and capturing components as they enter and are processed through the new manufacturing line. The Harmac requirement was a unique mix of line supervision, alarming, data acquisition and device history traceability and reporting.
Our Approach
The NeoDyne automation team worked closely with the Harmac engineering project team to design, deliver and validate a multi-platform digital manufacturing traceability system consisting of:
- Cognex Dataman Barcode Readers
- Sparkplug B enabled Cognex Edge Intelligence Devices
- Cirrus Link MQTT Modules
- Mobile responsive Ignition Perspective SCADA application
- Microsoft SQL Database
- SSRS Reporting
The solution was implemented in a Unified Namespace Architecture using Cirrus Link MQTT Modules to transform the Ignition server into a MQTT broker which in turn subscribed to data from Sparkplug B enabled edge hardware. This allowed the transfer of data from the plant floor devices all the way to the Ignition application and SQL database via the MQTT . Benefits of this approach over a traditional Industry 3.0 approach included a lightweight, scalable infrastructure that lends itself to easy interoperability with other enterprise systems in the future. The use of the latest Cognex Edge Intelligence device along with its built in MQTT capabilities meant that our Edge device information was automatically discoverable to other Industry 4.0 applications interested in it.
About Harmac Medical
Harmac Medical is an innovative, full-service contract manufacturer of single-use medical devices, serving the global marketplace since 1981.
Harmac provides integrated technical solutions and full manufacturing services for companies of all sizes including leading Fortune 500 med-tech companies.
Customer Requirements
- The system must conform to 21 CFR Part11
- Eliminate paper as an information carrier
- The ability to scale the system to an unlimited number of operator clients
- The ability to deploy the application on traditional PC clients or Mobile devices
- The ability to log label data both manually and also via barcode readers
- Flexible application design that could be easily updated to match a changing production line layout
- Delivery of custom SCADA application to display dashboards relating to process critical timings
- Alarming system to notify operators when a product has gone out of specification
- System capable of linking components together during the kit making process
Challenges
- Manufacturing production process was still being designed in parallel – team needed to be adaptable and agile to react to design changes
- Complex Ignition scripting and SQL logic required to track and link components throughout the process
- Interface between different software and hardware technologies
- Ensuring production wasn’t impacted on the Castlerea site during the system implementation
Outcome
- Successful digital manufacturing traceability system meeting all customer requirements
- Introduced a Unified Namespace Architecture to the site that will enable future production lines to be seamlessly added to the system as required with minimal engineering effort
- Any MQTT enabled application within the enterprise can now view the current state of the plant through the MQTT broker which is the single source of truth
- 21CFR11 compliant solution
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Introduced latest cutting edge technologies with system capabilities maximised, including:
a) MQTT Protocol
b) Sparkplug B formatting
c) Edge Hardware - Delivered scalable system architecture with a lean, stable server footprint
- Forged new relationship with the customer
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