New Parenteral Launch Facility

Industry

Pharmaceutical

Business Issue

The customer needed a new automated fill/finish facility to provide small lot sizes of new pharmaceutical products as the company prepared the production facilities for full capacity manufacturing of the new product.  The automation design needed to allow for flexibility because of the variety of products that would be handled by the facility.

Due to several imminent new products, the project was on a compressed schedule.

Project Summary

The project included design, development, installation, validation, startup and commissioning of a new Parenteral Launch facility.  The stick built automation systems follow S88 standards and are fully validated pharmaceutical systems.  The plant uses DeviceNet bus technology.  The system has approximately 3,000 I/O points.

This fast track project required upfront automation design and specification to ensure that the various original equipment manufacturers (OEM’s) developed their equipment controls according to project standards allowing easy integration into the Plant Automation Systems and MES system.  Due to the global locations of the OEM’s, Cornerstone provided significant coordination and technical support to the OEM’s.

Scope Responsibility

Cornerstone Controls was responsible for the following areas:

  • Project management of process control engineering team.
  • Automation Consulting:
    • DeviceNet Design
    • Automation Standards and Design
    • OEM controls design
  • Automation engineering design and development of stick built systems utilizing Rockwell ControlLogix PLC, RSView 32 HMI and RSBizWare historian system.
  • Coordination of OEM automation delivery to specifications and standards. 
  • Supported integration of control systems to Flowstream MES.
  • Plant Systems included:
    • Seiberling CIP/SIP Compressors
    • Plant and Clean Steam Generators
    • Plant Equipment and Breathing Air
    • BOC Lyophilizers
    • Getinge Equipment Washer
    • Dongen Transfer Equipment
    • Seidenader Visual Inspection Equipment
    • Bosch Vial Washers
    • Getinge Sterilizers
    • VHP
    • WFI
    • WBSO
    • Bosch Filler
    • Formulation/Media Prep
    • Waste Neutralization
    • Budzar Glycol Chillers
  • Control system panel design and build.
  • OEM equipment FAT support.
  • Software validation of new systems including developing and executing a Master Validation Plan, Test plans, Test Cases and Installation and Operation Qualifications.
  • Facility Startup and Commissioning Support.

Results

The facility was successfully automated and validated on time and within the client’s budget.