Project: Liquids Batch Manufacturing & Storage
Industry: Consumer Products
Application: Liquid Batching/Material Handling
A leading manufacturer recently of consumer healthcare products needed to expand production at an existing facility to respond to changes in the marketplace. The plant expansion included the addition of a new manufacturing area to provide additional capacity for existing products as well as new products that were being developed to respond to consumer demands.
The manufacturing area consisted of the following:
• Staging areas for storing pre-weighed manual additions.
• Two redundant charging suites where the concentrated slurry is mixed.
• Five batch tanks where the concentrated slurry from either charge suite is combined with bulk materials to produce the product.
• Two storage tanks each capable of being fed from any batch tank. The storage tanks are capable of providing finished product to any combination of seven high-speed packaging lines.
The requirements for the control system in the new manufacturing area included:
• A Flexible Batching System compliant with ISA S88 standards.
• Process visualization, electronic work instructions and alarm management.
• Generation of Electronic Batch Records (EBR).
• Compliance to 21 CFR Part 11 for electronic records and electronic signatures.
• Interface to multiple plant systems including the plant MES.
• Integration to the site’s weigh and dispense system using wireless bar code scanners.
• Generation of IOQ documents and validation support.
The challenge was to design, implement and install a large-scale sophisticated system in a regulated industry under a tight schedule and budget without compromising high corporate standards. The design and development process closely followed GAMP 4 guidelines, relied heavily on the ISA-S88 model, and used EZSoft’s ControlBuilder®, a software development toolset. The ISA S88 model applied to all aspects of the project including gathering of information for the specifications, system design, documentation, testing, commissioning and validation. Key to the success of the project was ControlBuilder®, a data-centric software toolset that facilitated the collection of information gathered during each stage of design and development.
• EZSoft ControlBuilder® as a system development tool.
• Intellution iBatch for Batch Control.
• Intellution iFix for Supervisory Control and Data Acquisition.
• Allen Bradley ControlLogix programmable logic controllers for real time control.
• Microsoft SQL Server 2008 as the secure, compliant data warehouse to store batch data, audit trail information, and alarm log.
• Symbol wireless bar code scanners.
• Crystal Reports reporting engine on the corporate network via ASP.NET web applications.