Digital transformation is driving the trajectory of the entire industrial automation industry. It is particularly demanding for life science process manufacturers to effectively harness data from GMP-compliant equipment. The challenge presented by increased interconnected data is that the legacy of (appropriately) stringent quality and validation processes do not keep pace with the speed of digital progress.
Identifying and maximizing efficiencies of tech, especially where beneficial to quality, is essential to remain competitive. The development and startup of new equipment present significant opportunities for cost and schedule optimizations.
Both custom and commercial-off-the-shelf equipment come equipped with shiny new technologies and enhanced data capabilities. However, the final step of integrating these systems into an existing, interconnected enterprise framework falls squarely on the facility's shoulders. This a task that involves comprehensive GMP (good manufacturing practice) documentation and acceptance testing for both the new equipment and existing systems, which will be handling an increase of operations data.
Modern facilities, even smaller ones, often feature a complex array of virtual servers supporting SCADA, process historians, ISA88 batch systems, and various other databases and services. Larger facilities may add DCS, thin client managers, asset management software, protocol gateways, CMMS and MES.
Regardless of if these services are on premises or in the cloud, this shift towards a distributed infrastructure facilitates exciting new opportunities for data analytics. At the same time, it poses significant challenges to seamless equipment integration.
The most cost-effective and impactful modifications to equipment occur at the vendor’s site before it is shipped to the facility. Addressing the inevitable issues at this stage saves both time and resources. All the required personnel and tools are readily available and motivated to get the equipment shipped out of their shop.
Enter the solution: a portable operations station.
Housed in a rugged travel case, this station contains a high-end industrial PC running essential virtual machines like SCADA, I/O gateways, process historians, SQL databases, and domain controllers. Everything a healthy GMP facility needs to produce quality-controlled biologics. The option to include advanced features such as ISA88 batch for process recipe testing, reporting or dashboarding frameworks, and even remote access is also available.
In an application where we used this strategy, we had a set of bioreactors and purification skids equipped with only remote I/O. One ControlLogix PLC in the portable operations station was more than enough to control multiple machines. This client grouped its equipment by area: media prep, upstream and downstream. This equipment strategy could be adapted for one controller running a single cell line. Simplifying the control architecture further reduced costs and minimized change control.
The portable operations station architecture empowers automation teams to expedite the standard factory acceptance testing (FAT) such as wire verifications, power loss/recovery and device actuation. In addition, a portable operations station allows expansion into more communication and process-related advanced functional testing. Even before the equipment arrives on site, you can begin to quantify the typical unknowns prior to site integration. Examples of this include:
- IT/OT communications: Misconfigured VLAN or NAT? Abnormal traffic or latency? Loss/establishment of comms for smart devices?
- Equipment module phases: Valve alignments synchronized? Timing between valve opening and pump speed off? Initial PID tuning off? System unable to hit process values setpoints?
- Recipe test: Process-base transitions as expected? Unexpected nuisance alarms? By conducting thorough testing under GMP-compliant change control, much of the site acceptance testing and installation/operational qualification can be streamlined or reduced upon the system’s arrival to the facility.
Leveraging the FAT and resolving issues at the vendor's location can double the time savings during site startup and acceptance testing. The savings will more than cover the cost of the portable operation station and the initial labor to get it configured.
Moreover, this approach offers invaluable hands-on experience for automation teams. Reducing the equipment ramp up time, dry running acceptance testing, and aiding in training and procedural development are additional benefits. When the equipment arrives on-site, it comes with the assurance of a smooth integration into the local infrastructure.
In addition, once the primary function to bring site infrastructure to the FAT is complete, it can be readily repurposed for future equipment FATs, offline training, process development, or even as a source for spare parts.
In the quest for highly integrated data systems, the ability to bring a slice of your facility’s infrastructure to the equipment vendor’s site opens doors for significant cost savings and schedule efficiencies. Give yourself the gift of accelerated insight by identifying the potential gaps and challenges as early as possible to help you deliver organizational success and sleep easier at night.
Bill Mueller is the founder and senior engineer of Lucid Automation and Security, an integrator member of the Control System Integrators Association (CSIA). For more information about Lucid Automation and Security, visit its profile on the Industrial Automation Exchange.
