Case Study

Optics Healthcare Manufacturer Upgrades Critical Automation in Record Time to Meet Regulatory Compliance

Objective

A healthcare producer focusing on optics had systems critical to their manufacturing process that desperately needed replacement. The client had an obsolete environmental monitoring system (EMS) and purified water controls consisting of:

Old and no longer supportable technology/servers
PLC Hardware was old and obsolete with I/O modules no longer available from the OEM
System itself was constrained:
Had to dive into code to make changes
Not very user friendly for set-point changes
All reporting was completely manual

Malisko was requested to provide the client a more modern and validated system that was:

Contemporary hardware fully supportable for years to come
Robust networking
Operator friendly
More built-in compliant audit trailing
More intuitive troubleshooting
More automatic reporting
Meeting all regulatory compliance for Computer System Validation (CSV)

CHALLENGES

Very aggressive project schedule – both pre-installation and on-site work.
Client’s shutdown window was 3 weeks – all work had to be completed including CSV within the window or client would fail to meet contractual obligations for product delivery:
Remove all hardware and panels (6 I/O panels) then install and operationally check out new ones
I/O checkout + Validation (aggressive scheduling) including IQ, OQ and PQ
Client was foretold by other Integrators “..it could never be done in 3 weeks…”
Prior to getting involved, other integrators at the plant told upper management that this would be a “multiple shutdown event”
“No way you can get it done in one shutdown”
Client was not sure existing documents were up-to-date and accurate; therefore, wiring schematics needed to be verified prior to designing the new system.
The client wanted an I/O network design based on relatively new technology (bleeding edge) thus raising the risk factor of not meeting the time constraints for system cut-over due to potential unknowns unless Malisko executed relentless vetting and testing of the network design prior to deployment:
Parallel redundancy protocol on the I/O part of the network, such as the remote racks.

SOLUTIONS

Services rendered:

Controls – New PLC controllers and I/O hardware – Specify, document, configure, program and test
HMI SCADA – Specify, document, configure, program and test
Network – Specify, document and configure
Project management
Procurement
Contract oversight
Validation –
Generated all documentation from Validation Master Plan through Qualification Protocols to Validation Summary Reports
Participated in executing the validation protocols
New server – virtualized server architecture
New plant-wide manufacturing network infrastructure
Cables, switches, etc – both physical and logical
Software – FactoryTalk ViewSE
Redundant ThinClient technology
Historian upgrade
Added to earlier upgrade with this project
Automated reporting upgrades

RESULTS

Able to rip and replace along with fully validate and turn over to the plant the new compliant systems within the 3 week window – client was able to meet contractual obligations.
Provided system that’s easier for operators to navigate, oversee and manage the processes:
Two large ThinClient screens in control room
Each ThinClient view screen split into 4 quadrants
EMS system displayed on the top screens and Purified Water system on bottom
Alarms displayed in a single pane of glass
More efficient in monitoring the critical production systems after project completion
Monitoring rooms’ environmental conditions at a very granular level – greatly reducing the risk of non-spec product being released for shipping
Contemporary controls, I/O, network and server hardware supportable for many years to come
System is validated and fully compliant with FDA regulations for governing CSV
Client has a fully-supportable, robust automation and reporting system meeting regulatory compliance

FOOTNOTES

Malisko and the Client’s project team received tremendous praise from client management after the successful completion of the project for meeting all expectations of being in budget, meeting system requirements and completing all deliverables within the tight time constraints.

LEARN MORE

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