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  • Sieo-

  • Preparation of Injectable Solutions in Bags Start Date: 01/15/2016
    Completion Date: 01/08/2016

    Project: A manufacturer of high-quality pharmaceutical solutions developed a new production line with systems and equipment that had to ensure consistent compliance with the standards of the Food and Drug Administration (FDA). The speed, accuracy, and 100% reliability of these systems are crucial.

  • Project Objective: The project's goal is to develop, on time, the client's rigorous construction program with over 64 input/output points and 120 process valves, in addition to batch control. The client utilizes a combination of stainless steel solution tanks whose level must be weight-controlled using ultrasonic level sensors. Temperature and pressure are also measured during production and cleaning processes.

  • Sieo

  • Overview

    • Control Platform

    • SIMATIC WIN CC 7.2

    • SIMATIC LOGON

    • S7-1500

  • Client Results

    The PLC system underwent factory acceptance testing by the client before delivery. These tests revealed inaccuracies in the panel and the control program's operating design. Working within a tight schedule before delivery and execution, Grupo SIEO engineers redesigned the panel drawings and modified the program to reflect a functioning system. The client was pleased because Grupo SIEO had the experience to develop a functional system, and potential startup issues were mitigated during the testing phase. Once engineering was complete, and panels were delivered, the installation task commenced and met project requirements and schedule for timely and successful project control. The delivered system was qualified for FDA audit, passing the audit without the need for subsequent modifications.

  • Compliance with Regulations and Standards

    The project was designed and developed to comply with the following regulations:

    EU CFR-21 (Code of Federal Regulations), Parts 210 and 211 (Good Manufacturing Practices, April 2007), Part 11 (Electronic Signatures and Records, August 2001), and Part 820 (Software Validation and Automated Equipment, April 2007).

    GAMP4 Guide for Validation of Automated Systems, December 2001, Published by ISPE.

    General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002.