Real-World Example: Equipment Qualification of a Pharmaceutical Still

Introduction

Equipment Qualification is an essential component of GMP compliance. It ensures manufacturing equipment works reliably and as intended. This article covers a real-world example of the qualification of a still starting with Installation Qualification (IQ) and followed by Operational Qualification (OQ), or IQOQ (or IOQ when a combined protocol is used). These steps are part of the broader facilities, utilities, and equipment qualification framework, which sets the foundation for process reliability and product safety, quality, identity, potency, and purity.

Equipment Qualification typically requires cross-functional teams—Validation, Engineering, Quality Assurance, Maintenance, Calibration, Operations, and Quality Control. It’s a collaborative effort that affects and involves every part of the manufacturing operation.

What is a Still?

In pharmaceutical manufacturing, a still is a piece of equipment that uses distillation to produce purified water or solvents. It heats the liquid to generate vapor, then condenses that vapor back into liquid form, thereby removing the impurities. Stills are commonly used to produce Water for Injection (WFI) or Purified Water, to meet strict pharmaceutical standards.

Prequalification Activities

Before starting formal IQOQ, the project team conducted essential prequalification steps to ensure alignment and technical readiness:

• Collaborative Planning with Stakeholders
  The qualification team partnered with contractors and the client’s engineering and quality teams to understand the timeline and milestones that were important to consider.
• Engagement with Subject Matter Experts (SMEs)
  SMEs helped identify the critical functional aspects of the still, ensuring that test cases and acceptance criteria were accurate and aligned with user requirements.
• Protocol Development and Approval
  A comprehensive IQOQ protocol was developed, the scope was thoroughly detailed, and objectives, test methods, and responsibilities were clearly explained and outlined. The protocol underwent a formal approval process prior to execution ensuring compliance and alignment with all departments.

Installation Qualification (IQ)

Installation Qualification confirms that the still has been installed per design specifications and is ready for operation. Key IQ activities included:

• P&ID Walkdowns
  The system was physically walked down and verified against Piping and Instrumentation Diagrams (P&IDs) to ensure proper installation of components, instrumentation, and control systems.
• Verification of Utilities and Safety Systems
  All required utilities such as steam, chilled water, compressed air, and electrical connections were verified. Safety features like pressure relief valves, interlocks, and alarms were also tested.
• Component Verification
  Major system components and product contact materials were reviewed for compliance with specifications and material certificates, ensuring correct materials of construction (e.g., 316L stainless steel).
• Leak Testing
  • Vacuum Hold Test: Used to confirm system integrity under negative pressure.
  • Utility Leak Checks: Steam and water circuits were tested for leaks under normal operating conditions.

Operational Qualification (OQ)

Operational Qualification demonstrates that the equipment performs as intended under controlled, simulated conditions. For this still, OQ testing involved:

• Agitator Speed Verification
  A tachometer was used to confirm that the agitator speed remained within specified tolerance limits.
• Cleaning Coverage Assessment
  A riboflavin test was performed to validate the cleaning effectiveness of the Clean-in-Place (CIP) system. Areas that were not adequately cleaned were detected by the residual riboflavin using UV light.
• Recipe Simulation and Functionality Testing
  All functional aspects of the still were tested,
  • Heating and cooling sequences
  • Control setpoint responses
  • Integrated alarms and interlocks

Data was collected and compared to the predetermined specifications.

• Vessel Drainage Check
  The system was filled and drained to confirm no standing water remained in the vessel.
• Receiver Functionality (if applicable)
  For stills equipped with a receiver, tests confirmed proper drainage when the system reached high-level setpoints.

Conclusion

This project demonstrates the importance of detailed Equipment Qualification through rigorous IQ and OQ activities. By executing Installation Qualification and Operational Qualification, the client verified that the still was installed correctly and functioned as intended.

The IQOQ process not only ensured equipment readiness but also laid the foundation for compliant and repeatable manufacturing operations.

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