13 Jun 2012

Granulation and Kettle Control

Application Notes No Comments

Project: Granulation and Kettle Control
Industry: Pharmaceutical
Application: Granulation

Overview
A leading pharmaceutical manufacturer upgraded their controls for a Fluid Bed Granulator and associated Starch Kettles with an S88 Component Based Control Systems. The process consists of preparation of starch solution in one of two (2) Starch Kettles and discharging into the Fluid Bed Granulator at a designated flow rate.

The Starch Kettles are used to prepare solutions for the granulation process. Each Starch Kettle Solution tank is mounted on load cells and equipped with a two-speed mixer, USP PW supply valve with full and dribble flow control, hot water supply valve, variable speed solution pump and an automatic discharge valve. The tank is also jacketed to allow heating the solution. Batch and CIP functions are sequenced automatically and operator prompts are configurable in the recipe to confirm operator actions.

The Fluid Bed Granulator includes a fluidizing air handling unit with variable inlet valve and air heater, product bowl pressure seals, solution spray nozzle with atomizing air; bag filters with shake function, variable exhaust damper and exhaust fan. The batch and CIP functions are sequenced automatically and operator prompts are configurable in the recipe to confirm operator actions. Moisture data is collected during the spray phases and graphed against target and operational limits. Critical process parameters such as air flow, air temperature, product temperature, moisture and solution flow rate are prominently displayed on the operator display for monitoring. The system includes a data collection and reporting sub-system for producing batch reports, alarm reports and an audit trail that complies with Title 21, Part 11, Subpart B – Electronic Records, section 11.10 for closed systems.

Highlights
The previous system was operated by manually setting loop set points per SOPs and was prone to operator error. The new system includes the Batch Manager component from EZSoft ControlSuite™ allowing flexible recipes and consistent and reliable automatic batch execution. The Report Manager component from EZSoft ProductionSuite™ provides accurate data collection to support investigations and process improvement initiatives. The recipe configuration on the new controls allows each of the phases to be executed in any order either individually or in parallel with other phases. This flexibility enables the production of new products within the physical capability of the equipment without changing software. The recipe storage and the batch engine reside in the PLC. The reporting system captures all recipe changes and provides an audit trail of operator actions.

EZSoft provided detailed design specifications and generated test protocols for system qualification. During the factory tests, EZSoft engineers used the simulation capabilities of Device Manager to perform comprehensive tests of all graphic objects, phase and unit operations. This quality testing significantly reduced startup and commissioning time and enabled the Factory Acceptance Tests to be referenced in the Operational Qualification Protocol saving time and validation costs.

Products Used:
• EZSoft ProductionSuite™ including:
- Report Manager

• EZSoft ControlSuite™ including:
- Batch Manager
- Phase Manager
- Device Manager
- Alarm Manager
Microsoft SQL Server 2008 w/ Reporting Services for data storage and reporting.
Rockwell Software FT Transaction Manager for data acquisition from the PLC
Allen Bradley PanelView Plus Operator Interface terminals.
Allen Bradley ControlLogix programmable logic controllers for real time control

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