Pharma Manufacturing Control Automation Project Details
Scope of Work :
- 7star Graphics development for Plant, AHU, riser,VAV, SAV,EAV etc
- 5 star Graphics development for Plant, AHU, riser,VAV, SAV,EAV etc
- 3D Graphics development for Plant, AHU, riser,VAV, SAV,EAV etc
- PLC software development
- Device/ Instrument list preparation
- IO list preparation
- Alarm Parameter list preparation
- Installation Qualification
- Operational Qualification
- SAT HD (Hardware Design)
- SAT SW (Software Design)
- FAT HD
- FAT SW
- Unit Level Functional Design Specification (ULFDS)
- System Functional Specifications (SFS)
Platform: HC900 Hybrid Controller & DDC Controller
Precision Control Systems for USA Pharma Manufacturing: A Case Study in Compliance and Performance
In the highly regulated and exacting world of pharmaceutical manufacturing, robust and compliant control systems are fundamental to product quality, patient safety and operational efficiency. For a leading pharmaceutical facility in the USA, iPAC Automation delivered comprehensive control system automation services, demonstrating our capability to meet stringent global standards.
Our expertise ensures that every aspect of a pharma plant, from critical HVAC systems to complex process units, operates with verified accuracy and unwavering reliability. This project highlights our commitment to delivering verifiable and high-performance automation solutions that uphold industry regulations and drive productivity.
Our Comprehensive Scope of Work for a US-Based Pharma Facility:
This significant project involved a detailed approach to control system implementation, focusing on meticulous design, thorough development and rigorous validation. Our team applied extensive knowledge of pharmaceutical automation requirements throughout the entire process.
- Advanced Graphics Development: We created intuitive and detailed Human-Machine Interface (HMI) graphics, including:
- 7star, 5star and 3D Graphics: For comprehensive visualization of the entire plant, as well as specific systems like Air Handling Units (AHU), risers, VAVs (Variable Air Volume), SAVs (Supply Air Volume) and EAVs (Exhaust Air Volume). These advanced visual tools provide operators with clear, actionable insights into facility status.
- PLC Software Development: Our engineers developed robust and reliable PLC (Programmable Logic Controller) software, forming the core logic for precise control of all manufacturing processes and facility operations. This ensures consistent and accurate execution of critical sequences.
- Meticulous Documentation & Lists: We prepared essential documentation that is vital for compliance and operational clarity:
- Device/Instrument List Preparation: A comprehensive catalog of all control devices and instruments.
- IO List Preparation: Detailed mapping of all input/output points for the control system.
- Alarm Parameter List Preparation: Defined parameters for all alarms, ensuring appropriate responses to operational deviations.
- Rigorous Qualification and Testing: To guarantee system integrity and compliance, we performed extensive testing and qualification activities:
- Installation Qualification (IQ): Verified that all components were installed correctly and met design specifications.
- Operational Qualification (OQ): Confirmed that the system operated as intended under various conditions.
- SAT HD (Hardware Design) & SAT SW (Software Design): Site Acceptance Testing for both hardware and software, ensuring functionality upon installation.
- FAT HD (Hardware Design) & FAT SW (Software Design): Factory Acceptance Testing for hardware and software, pre-validating the system before shipment.
- Structured Functional Specifications: Our approach included detailed specification development to ensure clarity and alignment with project requirements:
- Unit Level Functional Design Specification (ULFDS): Defined the functionality of individual units within the system.
- System Functional Specifications (SFS): Provided an overarching blueprint for the entire control system’s operation.
- Platform Expertise: The project utilized the robust HC900 Hybrid Controller & DDC Controller, showcasing our proficiency with advanced and industry-specific control platforms.
Achieving GxP Compliance and Operational Excellence
This project underscores iPAC Automation’s ability to deliver automation solutions that meet the rigorous demands of pharmaceutical manufacturing, especially for facilities adhering to US regulations. Our focus on comprehensive graphics, precise PLC logic, thorough documentation and exhaustive qualification processes helps clients achieve:
- Verifiable Compliance: Adherence to GxP guidelines and other industry standards.
- Consistent Product Quality: Stable processes minimize deviations and maintain integrity.
- Efficient Facility Management: Optimized control of environmental and process parameters.
- Reliable Operations: Minimized downtime and enhanced system stability.
Partner with iPAC Automation for Your Pharma Automation Needs
When precision, reliability and regulatory adherence are non-negotiable for your pharmaceutical manufacturing facility, iPAC Automation provides the engineering depth and proven experience you require. We are ready to support your most critical automation projects.
Ensure your pharmaceutical operations are controlled with proven expertise.
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