Aseptic Production Facility Capacity Expansion

Aseptic Production Facility Capacity Expansion
Customer Profile:

Integrated Automation for Batch Process / SCADA / PLC Control System(s)
(Aseptic Formulation, Sterile Storage, Aseptic Filling and Clean Utilities)

Background

A major pharmaceutical company in NC expanded their manufacturing capacity by adding a new production line, thereby greatly increasing the production volume of one of their critical medications. This new line capacity expansion added Aseptic Formulation and Storage suites with dedicated CIP/SIP skids, as well as a new Aseptic Filling suite. To support this new production line, the existing WFI Generation, Storage and Distribution systems were also expanded and a new Component Preparation machine was added to the site.

Avid Solutions was selected to provide the Process Automation design and implementation support for all of these applications and areas. Our long-term Trusted Partner relationship was instrumental in the evaluation and selection of the System Integration partner for this project. Cohesive coordination with site automation, IT, validation, production and quality departments would be critical to project success, as it would be strategically phased into plant operations of a several year time-line. The integrated project execution strategic plan would require several areas of focus: Minimize impact on existing production operations, Utilization of latest technologies, Conformance to client recommended global automation standards, as well as leveraging existing site standards, applications and technical expertise for familiarity and maintenance continuity.

Application

To meet all these objectives, Avid assisted with Gap Analysis of the existing production line requirements/capabilities compared to requirements of the proposed new production line. Platform selection was determined from this analysis criteria to ensure the delivery of this strategic project met all of the company goals. The decision was made to capitalize on existing platform and application experience and familiarity, while taking advantage of latest release capabilities and technology improvements.

System Life Cycle Documentation was developed/maintained for each of the systems affected by the scope of this project; from User Requirements through Qualification protocols. Our team worked closely with the client to identify areas of improvement available; examples of this included moving to a Virtual environment for all applications, incorporation of improved instrumentation/equipment, as well as process control improvements for greater reliability and performance.

Overall process application development included all of the automation PLC controls, as well as integrated Batch Control and SCADA systems for the new line systems, as well as existing plant systems (i.e. WFI, BMS, Data Historian, Reporting, Product Tracking, etc…). Coordinated support efforts with all of the OEM vendors was integral to project success; including design review, vendor FAT support and onsite commissioning /start-up assistance.

Avid also worked closely with the Validation and QA teams to develop the required validation documentation (RA, TM, IOQ), as well as supporting all IOQ execution of the new equipment from an Automation perspective. The phased implementation timeline of the project required coordinated activities to minimize repetitive and/or redundant execution throughout the project.

Results

Avid Solutions’ participation in all phases of the project allowed for a continuum of experience and knowledge, providing for the successful execution of the project while meeting all of the client goals associated with cost, schedule and production capacity growth. Side-by-side collaboration and teamwork with site Automation, IT, Operations, Validation, and Quality teams provided for an efficient, timely, and effective execution strategy throughout the project timeline. The early decisions related to platform selection, standards conformance and strategic improvements allowed for the achievement of increased production capacity goal while adding facility execution flexibility, allowing for greater maintenance and asset utilization effectiveness. This project is yet another example of how Avid helps our clients Run Better!

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