IIC Journal of Innovation 15th Edition | Page 53

IoT-Enabled Global Process Validation System
For example , in the above Figure 6 , if both predicted IPQC1 and actual IPQC1 test pass after Operation-1 Milling , then before the Operation2-Blending commences , IPQC2 test is predicted based on the results obtained after the actual IPQC1 test , i . e . Actual IPQC1 test result becomes one of the inputs to the predicted IPQC2 test . If this predicted IPQC2 before the Operation2- Blending fails , then APC prescribes adjusted parameter settings for Operation 2 – Blending within the validated limits , such that the “ Operation 2-Blending ” results in a positive predicted and eventually actual IPQC2 test results . Thus , this real-time process optimization minimizes overall batch rejection and improves manufacturing efficiency while ensuring that the validated process is not compromised .
In a commercial manufacturing setup , the IIoT solutions such as IoT-enabled process validation system with APC capabilities can be successfully implemented in two ways :
1 . Revalidating the entire process with APC embedded process automation and establishing a new validated process ; and
2 . Creating a parallel path for manual decision making that does not interfere with the existing validated process
In both these cases , it is essential to ensure the trustworthiness of the overall production system is not compromised . As defined by IIC “ Trustworthiness is the degree of confidence one has that the system performs as expected with characteristics including safety , security , privacy , reliability and resilience in the face of environmental disturbances , human errors , system faults and attacks ” 8 . Since , Industrial IoT systems are complex by nature as they are comprised of many systems and subsystems of both operations technology ( OT ) and information technology ( IT ) world , it becomes extremely critical that , the proposed IoT-enabled process validation system is designed to ensure high trustworthiness is achieved at an individual system level and upon integration with other systems .
Thus , a trustworthy IoT-enabled global process validation system with APC capabilities , that has the potential to connect to disparate data sources and analyze historical and real-time operational , asset and environmental batch data and that offers a wide range of analytical capabilities from basic descriptive and diagnostic analytics to more advanced predictive and prescriptive analytics will play a significant role in supporting life sciences manufacturers and
8 https :// blog . iiconsortium . org / 2018 / 10 / trustworthiness-and-the-permeation-of-trust-in-iiot-systems . html
- 48 - November 2020