Clean and Dirty Utilities in Biologics Projects

Clean Utilities

These utilities come into direct or indirect contact with the product, manufacturing environment, or packaging and must meet strict GMP (Good Manufacturing Practice) and GxP requirements.

Examples:

• Purified Water (PW)
• Water for Injection (WFI)
• Clean Steam
• Process Gases (Nitrogen, Compressed Air, CO₂, O₂ – when in contact with product)
• HVAC for classified cleanroom environments

Purified Water | Water for Injections | Purified Water Systems

Commissioning of HVAC Systems

 

Dirty Utilities

These do not contact the product and are primarily used for support functions. They don’t require the same stringent GMP controls but must still be reliable.

Examples:

• Chilled Water
• Steam (Plant Steam)
• Industrial Gases
• Non-GMP HVAC
• Waste Management Systems
• Compressed Air (non-GMP)

Qualification Requirements: Clean vs. Dirty Utilities

Water for Injections I Clean Utilities I WFI I Purified Water I

 

Step-by-Step Utility Qualification Process

For Clean Utilities

1.     Design Qualification (DQ)

• Ensure system design meets URS (User Requirements Specification)
• Review P&IDs, specifications, and materials of construction
• Document: DQ Report

2.     Installation Qualification (IQ)

• Verify equipment/system is installed per design
• Review calibration certificates, component tags, wiring, etc.
• Document: IQ Protocol & Report

3.     Operational Qualification (OQ)

• Test system operations against functional specs
• Include alarm testing, control ranges, safety features
• Document: OQ Protocol & Report

4.     Performance Qualification (PQ)

• Test system under load conditions (e.g., actual production)
• Monitor microbial/chemical parameters (e.g., for PW/WFI)
• Document: PQ Protocol & Report

5.     Validation Summary Report

• Summarize DQ-IQ-OQ-PQ
• Justify operational acceptance
• Document: VSR

6.     Periodic Review & Requalification

• SOP-driven requalification
• Trending & deviation reviews

For Dirty Utilities

1.     Engineering Design Review

• Ensure GEP compliance
• Evaluate efficiency, safety, capacity
• Document: Engineering Design Assessment

2.     Installation & Functionality Check

• Check installation as per design
• Confirm operational capability
• Document: System Verification Report

3.     Performance Tests (where required)

• System pressure, flow, alarms
• Calibration of key instruments
• Document: Functionality/Performance Test Report

4.     Handover to Maintenance

• Ensure preventive maintenance plan is in place
• Document: Handover Certificate

Documentation Package

• URS (User Requirements Specification)
• FS/DS (Functional/Design Specification)
• P&IDs, GA Drawings
• Risk Assessment (FMEA)
• DQ/IQ/OQ/PQ Protocols & Reports
• Calibration & Maintenance Logs
• Validation Master Plan (VMP)
• SOPs (System Use, Sampling, Cleaning, Maintenance)
• Traceability Matrix

GxP Cellators Consultants’ Expertise

GxP Cellators Consultants is a highly experienced team specializing in utility qualification for biologics manufacturing facilities, including greenfield and brownfield projects.

Services and Strengths:

1.     Clean & Dirty Utility Qualification

• Turnkey qualification for PW, WFI, clean steam, gases
• Engineering qualification in chilled water, plant steam, HVAC, and more

2.     Qualification Documentation Design

• Custom protocol development (DQ, IQ, OQ, PQ)
• Risk-based qualification approach aligned with ISPE & FDA guidelines

3.     On-Site Execution Support

• Expert-led testing and validation
• Deviation management, change control, CAPA documentation

4.     Site Utilities and HVAC Systems

• Full commissioning and qualification of HVAC (cleanroom grades A-D)
• Airflow visualization (smoke studies), recovery rate, pressure cascade validation

5.     GMP Readiness Programs

• End-to-end support for GMP inspections
• Readiness gap assessments and remediation plans
• Regulatory audit support and technical documentation review

Commissioning Qualification and Validation I CQV Services I GxP