October 1, 2026

Overview
A sterile injectable pharmaceutical manufacturer in the Midwest United States operates a long-standing, Rockwell Automation powered facility under strict FDA validation requirements. Two production lyophilizers relied on Kaye chart recorders to generate the paper records required for freeze-dry, sterilization and leak-rate testing. These recorders had been the validated standard for years, but the hardware was now obsolete and no longer maintainable, and every record they produced lived only on paper. That data sat outside the plant historian, outside electronic reporting and outside every other system the site depended on.

The consequences went beyond inconvenience. Cycle records had to be read off paper charts and handled manually for every batch, with no path into the historian for trending or querying. A recorder failure on unsupported hardware risked stopping a lyophilizer outright, and in a validated environment, a lost or illegible record is not a paperwork issue. It is a batch problem.

The client’s path to Grantek began with the client’s own team. Facing the same obsolescence problem, they had already sketched out a PLC-based replacement design using FactoryTalk View but lacked the internal bandwidth to develop it themselves, so they brought the design to Grantek to execute. Grantek recommended a change: replace FactoryTalk View with FactoryTalk Optix. The timing worked in the project’s favor. Grantek was already in discussions with the client about converting several iFIX and Fix32 HMIs to Optix, so the recommendation fit into a broader modernization narrative already underway. A few days before Grantek made that recommendation, Revere, the site’s local Rockwell Automation distributor, had independently given the client a demo of Optix and was promoting the platform to the same group of decision makers. Revere is also Grantek’s local distributor and integration partner, and the two companies worked together to make sure the client was getting the right PLC and Optix solution for the application. Through their combined efforts, the client is now committed to Optix as its primary HMI and SCADA platform going forward.

Challenges
The client’s own design had already solved the obsolescence problem with a PLC-based data acquisition system, a clear step up from another standalone recorder. But the software layer they had proposed, FactoryTalk View, would have produced a display-only interface with no direct path back into the plant historian. Grantek recommended FactoryTalk Optix as the data layer instead. It meant more validation work up front, but it placed the lyophilizer data permanently inside the same environment as the rest of the plant’s process data, rather than stranding it again.

Grantek implemented a CompactLogix 5069-L306ER, an upgrade from the 1769-L18ER originally specified in the client’s design, to take over the thermocouple and analog signals through Compact 5000 universal analog input modules, configured purely as a data acquisition system with no control function on the lyophilizer. A 12.1-inch FactoryTalk Optix panel served as the data layer rather than a simple display. Because the client needed validated cycle reports built directly from historian data, Grantek’s team used Optix’s NetLogic extensibility to build a purpose-built historian integration inside the application itself, in C#, rather than standing up a separate middleware layer. Optix logs batch start and stop events, operator comments and audit-logged manual entries, writes them into the historian as annotations against live tag values, then reads that data back to generate four PDF cycle reports: Registration Log, Freeze Dry Cycle, Steam Sterilization Cycle and Leak Rate Test, all written to 21 CFR Part 11 requirements so each PDF stands on its own as the official batch record.

The panel’s hardened appliance image meant the reporting and historian infrastructure had to be designed around its constraints, shaping the overall integration architecture. Grantek addressed this by fitting the reporting path within what the image allowed, then iterating the report layout and the manual-entry audit trail with the client’s quality group until the resulting PDF held up as a standalone batch record.

On the physical side, Grantek sourced a new 19-inch rack enclosure matching the footprint of the existing Kaye chart recorder and duplicated its terminal layout, so field I/O landed exactly where it had before, with nothing relocated and no field wiring rerun. The new panels connect to the existing plant network and to the plant historian rather than operating as standalone devices, so lyophilizer cycle data now sits alongside the rest of the site’s process data, available to anything that reads from that historian.

Solutions
The paper record is gone. Cycle reports are now generated as PDFs pulled directly from historian data, operator comments and manual entries are captured with a full audit trail instead of being scrawled on a chart, and the obsolete recorder hardware has been removed from the plant floor entirely. Optix also now handles domain-based security authentication for the application. Lyophilizer data that once lived in isolation now flows into the same historian that runs the rest of the site, giving the client the ability to trend and query freeze-dry, sterilization and leak-rate data for the first time.

Beyond the recorder replacement, the client is pursuing a separate, larger modernization effort: converting three iFIX and Fix32 HMI systems on standalone lyophilizers running SLC PLCs to Optix runtimes. This is a different scope from the recorder work, replacing full process-control HMI applications rather than chart-recorder data acquisition, but it is proceeding in parallel and reinforcing the client’s broader shift to Optix as a platform. A separate Optix project covering UPS data, alarm paging and visualization of critical utilities into SCADA has now been placed on order. A further proposal upgrading a SLC-based WFI control system with an iFIX HMI to a ControlLogix-based controller and Optix HMI is out to bid, extending the program even more broadly across the site.

The economics of reuse have been a real driver of momentum on the recorder-replacement side. Because the second lyophilizer application was built from the first, it was delivered at a significant reduction in engineering cost compared to the original build, a saving made possible because the initial application became a validated template rather than a one-off. That reuse advantage is specific to the recorder-replacement scope; the parallel HMI upgrade and utilities work are separate programs with their own requirements, but together they reflect a site-wide shift toward Optix as the client’s platform of choice.

For manufacturers still relying on standalone, obsolete recording hardware to generate validated batch records, this project shows a clear alternative: a data acquisition and reporting architecture built on FactoryTalk Optix and the plant historian, delivered without disrupting existing field wiring or panel footprints, and designed to scale as a template across an entire facility.