SINCE

Profitability in Automatic

Upgrade of an HVAC control system for the pharmaceutical industry

Situation

In a factory of the pharmaceutical industry, the client had a control system for his HVAC based on obsolete software and hardware, and also did not have support from the manufacturer.

Problems and Needs

In 2017, the situation of its HVAC system became critical, because in case the current system failed, there would be no support to restore it, causing data loss.

In this case, it was necessary to migrate the HVAC control system to a robust and reliable platform, in compliance with the standards and policies of the pharmaceutical industry and applicable regulations such as CFR 21, NOM-059, among others.

Reasons

Faced with the challenge of migrating the systems, it was known that it was a turning point for the organization, for which SINCI established a strategic plan to visualize the global project, both of the systems and of the infrastructure, to later plan each of the stages in an orderly and efficient manner.

Said planning was based on the experience of more than 30 years that we have, in pharmaceutical regulatory affairs, particular requirements of the area and above all in the good practices and industry standards with the CpWE, the GAMP 5 guide of the ISPE, NOM 059 etc., managing to combine a robust migration plan.

  • Upgrade outdated hardware
  • Update the control and visualization software of the HVAC System, complying with regulations of the pharmaceutical industry regarding logs (audit trail), security and process documentation.

A satisfactory solution

Specifically, the solution to upgrade the HVAC control system to a robust, reliable, fault-tolerant, high-availability platform.

  • The monitoring system was implemented in the IT infrastructure provided by the plant, which has three virtual servers, in which a client-server system was implemented, integrating the entire application into Active Directory.
  • In the control part we integrate a high availability architecture with a redundant system.
  • In the area of ​​networks, a DLR ring in fiber optics and copper was implemented, which guarantees great reliability in the collection of field signals.
  • Generation and delivery of the documentary package for compliance with the NOM-059-SSA1-2015 standard, as well as the documents for the preparation of the validation plan, preparation of the test protocols (IQ, OQ and PQ), traceability matrix, as well as the execution of validation and preparation of the validation report.

Results

As a result of the integration of this system, the results of the solution that SINCI generated were the following:

  • The modernization of the HVAC system to a robust platform and high availability fault tolerant.
  • The equipment, software and development have support and refurbishment.
  • With the update of the HVAC system, it was possible to control, monitor, generate the histories and reports of 15 UMAS, air compressors, purified water system, chillers and more than 500 field elements such as temperature, humidity, and pressure sensors, among others.
  • Complying with the requirements of the pharmaceutical industry, the documentary package for the validation of the computerized systems was delivered, adhering to the established IQ, OQ and PQ protocols, traceability matrix and validation report.

Do you require an update to your HVAC control system in your pharmaceutical laboratory?

The first step to integrate this type of solutions is through a technical visit. Contact one of our specialists to visit you and implement a marking system at your workstation.

CONTACT AN ADVISOR NOW

Reader Interactions