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16 BioPharm International ® Manufacturing and Facilities 2022 eBook www.biopharminternational.com OperatiOns management that can be maintained outside of the plant for employees to understand the process bet- ter—along with providing a resolution. When an issue persists, engineering design can be altered from root cause analysis for avoidance while also provid- ing a documented triaged solution to be presented in order to avoid long unplanned shutdowns. The employee also has access to all previous op- erational data while being able to manipulate the graphical representations for system analysis. One such example, shown in Figure 3, is being able to an- alyze multiple different points in time to understand process issues or compare KPIs for quality assurance. Figure 3 presents the product tank level in the upper por t ion of t he graph, t he pump discha rge ozone concentration in the middle por tion of the graph, and the inlet heat exchanger temperature in t he bot tom por tion. The lef t side of t he graph shows data right after a troubleshooting and tuning visit to stabilize performance and the right side is current operations. From the chart, there is tighter control on every variable on the lef t-hand side and erratic control on the right-hand side. This led the team to sug- gest operat iona l cha nges to ma i nta i n smoot her control of the system for increased reliability. This t y pe of a na lysis, when presented on ever y facet of system operation and made available to onsite operators, helps develop process acumen and the changes necessar y to smooth out system control. When t his information is paired wit h statistica l analysis, it can begin to depict major shifts in perfor- mance before a model alert is produced and forecast consumable lives. Figure 4 presents conductivity from two consecu- tive months along with consumption rates by month. The statistical distribution of conductivity presents a major shift and—when paired with consumption rates and utilization—predicts issues that could be a problem if system operations are not adjusted. Figure 4 presents the statistical analysis of Decem- ber 2021 on the left, January 2022 in the middle, and the monthly consumption rates on the right. There is a dip in consumption at the end of the year, and the rapid effect on reverse osmosis product conductivity from value distribution, shifting from roughly 6–9 micro siemens (μS) to approximately 11–14 μS when comparing the percentage of value distribution on the graphs. This major shift led the SME to present al- ternate modes of operation during low consumption periods to preserve membrane life and increase the operational life of the downstream equipment while bringing the expected conductivity back down after the system alterations. Another function of the software is monitoring all alarms and providing data analysis to know if the alarm is a nuisance or a true alarm that requires res- olution. This allows the OEM SME to understand if an alarm appeared temporarily because of a process ir- regularity or if it has continued and needs resolution or root cause identification. When troubleshooting efforts are required on site from alarms or anomalies, the SME is available to walk operators and techni- cians through the efforts needed to address the issue and is well versed in all equipment used within the system. This provides value in assisting the customer with troubleshooting efforts while also teaching op- erators about the equipment and arming them with troubleshooting deduction processes. This information is also used for alarm setpoint analysis and understanding of transmitter recalibra- tion efforts that are needed if an alarm is consistent. The alarm information arms the SME with data to do deeper dives to eliminate nuisance alarms, provides After Tuning: 549 DIST Ozone and Destruct\Distribution Loop Suppl... Current: 549 DIST Ozone and Destruct\Distribution Loop Supply Ozo... After Tuning: 549 DIST Ozone and Destruct\Distribution Pumps Disc... Current: 549 DIST Ozone and Destruct\Distribution Pumps Discharg... After Tuning: 549 Heater and Chiller\Distribution Heat Exchanger Inl... Current: 549 Heater and Chiller\Distribution Heat Exchanger Inlet Te... After Tuning: 549 Prod Tank and DIST Pumps\Ll-701 USP Tank Level... Current: 549 Prod Tank and DIST Pumps\LI-701 USP Tank Level... 0 - 55 60 65 70 75 80 85 % 20 - 40 - 60 - 80 - 100 - 120 - 140 - PPB 30 - 40 - 50 - 60 - 70 - 80 - Deg C FIGURE 3. Presents three different operating parameters at two different points in time for comparison.