Industry Case Studies, Life Sciences

Using OSISoft PI for Real-Time Performance Management

Background:
A Fortune 500 manufacturer of therapeutic and pain relief medications considered alternatives for replacing a long-standing legacy manufacturing system. This vanguard corporation sought to implement a replacement system utilizing newer architectures and technologies, which sustained the existing functionality and supported deployment to environments with additional requirements.

Situation:
The client operated a proprietary manufacturing system at multiple facilities, which was becoming obsolete due to inability to support the system and difficulty in integration with other systems. The system's legacy architecture and system components required significant maintenance resources. While the client needed to develop an up-to-date replacement for their current facilities, the new system also needed to meet additional requirements for their new production facilities. As such, the client decided to consider solution alternatives and implement a prototype to exercise and demonstrate various options. The prototype system would need to aggressively exercise various solution scenarios in order to determine the technical limitations of candidate third-party software tools with respect to the existing manufacturing system functionality and performance. A secondary objective of the project was the client's interest in learning more about OSISoft® tools and their applications. As such, knowledge transfer from EnteGreat to the client's personnel was an essential component of the project.

Solution:
The client requested that EnteGreat develop a project to test the capabilities of certain third-party tools in regard to the client's prototype manufacturing system. The new system concept was tested on the client's standard technologies in conjunction with OSISoft PI®, a world-leading platform for real-time performance management. The proof-of-concept prototype would evaluate and determine whether the functionality of the client's existing legacy system, as well as 21CFR Part 11 regulations, could be properly addressed using OSISoft's® suite of standard products. The goal of the project was to build a prototype using OSISoft's® tools.

The prototype produced a dataset similar to the dataset produced by the client's legacy system from a representative set of parameters. The project tested the manual data entry by lot and batch start time or end time with audit trail, error correction and data verification. The project also assessed the calculation of a single data point per lot using standard arithmetic functions and case logic. Furthermore, the project evaluated the association of time series data, the calculation of parameters across unit batches, and the storage of SPC control limits by lot. The steps involved in producing the required prototype demo were: creation of a simulation to provide batch data and time series data, configuration of PI Manual Logger® for manual data entry by lot number and batch start time or end time, and configuration of PI ACE® calculations to capture single data points at either the batch start or batch end. PI ACE® calculations were later adapted to FlexReports® once this tool became available.

Benefits:
The system prototype successfully recreated the required dataset for Statistical Process Control (SPC) reporting and exercised the architecture/tools to determine their limitations and overall suitability for the long-term solution. As a result the client received valuable knowledge from the project, which enabled the client to make a business-based decision regarding replacement of the existing manufacturing system. The introduction of PI FlexReports® facilitated the success of this project and showcased methods for applying that toolset in other functional areas for the client.