Centralized Plant Monitoring and Control System

Centralized plant monitoring and control system

Project objectives

Sector:

Pharma

TAKEDA's main need was to have centralized plant monitoring and control, since it had various equipment in the laboratories that, although they had certain automated systems, only offered supervision in "local" and were disconnected from each other.
TAKEDA needed to be able to record and historicize process data (measurements, audit-trail, etc.) in an agile manner and always in compliance with GMP/FDA regulations and data integrity (Data Integrity) and thus be able to respond to the requirements in the audits of administrations of the sector or relevant clients. For this, it required information in digital format that could be exploited with specific reports
It was required to have a robust and secure production system; to achieve this objective, the entire system is designed supported on a Virtualized infrastructure, and a Production infrastructure and another independent "Test-Validation" are implemented where all changes can be verified and qualified before their implementation in the production environment.
The design made based on standardized templates and the use of a Product Suite that has an important network of certified companies, provides TAKEDA with a solution that allows it to grow in the future at the rate and in the way that the organization establishes.

Challenges

The solution developed consists of a Centralized Supervision and control system of the “Production”, based on Wonderware System Platform
2017, which allows the monitoring and control of all plant processes, the historization of process data, and the provision of a
validation environment that allows them to verify all changes at the level of the control and supervision system, before their implementation in the production environment.
The implemented solution is redundant and uses RDS (Terminal Service) technology for the remote connection of clients, as well as access security
based on Microsoft Active Directory, resulting in a robust architecture and compliance with the regulations for validated systems.

Result

This system has allowed TAKEDA to respond to key aspects of “quality”, since it complies with FDA/21 CFR part 11 regarding the integrity
of the data. The new production reports allow TAKEDA to verify the correct conditions in which its products have been made, as well as to give
agile responses to the regulatory and audit requirements of the sector.
In addition, it has directly impacted greater productivity and efficiency by streamlining the implementation and validation of changes or new areas in the production environment. Plant downtime has been reduced by having a Test-Validation environment.

Solutions and products used

System Platform

Takeda is a multinational biopharmaceutical company originally from Japan, with different headquarters in more than 80 countries around the world and with more than 230 years of history.

Oasys is an integrating company of specialized solutions in automation, digitization and industrial control that works with important clients from various sectors such as Takeda, AENA, Transports Metropolitans de Barcelona or Grifols among others.