Utility Systems Validation
Comprehensive Utility Systems Validation Services
Why Validate Utility Systems?
Utilities like water, steam, and compressed gases are often direct product contact components. Their quality and reliability are not optional—they are fundamental to:
Product Safety: Preventing contamination that could compromise patient health.
Process Consistency: Ensuring utilities perform reliably batch after batch.
Regulatory Compliance: Meeting strict requirements from USFDA, EMA, WHO, and other global agencies.
Data Integrity: Providing documented, audit-ready evidence of system control.
Compliance & Standards
Our protocols and executions are designed to meet all major global compendia and regulations:
USFDA: 21 CFR Part 211
EU GMP: Annex 1 and Annex 15
Pharmacopeias: USP <1231>, EP, IP
ISO Standards: ISO 8573 (Compressed Air), ISO 13408 (Aseptic Processing)
ASME BPE: For bioprocessing equipment standards
Our Utility Validation Services
We provide a full suite of qualification services (DQ, IQ, OQ, PQ) for all critical plant utilities.
1. Pure Steam & Steam Quality Testing
We validate pure steam generators and distribution systems to ensure steam is suitable for sterilization and product contact.
Non-Condensable Gases: Measures inert gases that can impair sterilization efficiency.
Dryness Fraction: Verifies the steam’s thermal energy content and effectiveness.
Superheat: Ensures steam is at the correct saturation temperature for optimal heat transfer.
2. Compressed Air & Gas Validation
We test compressed air (instrument, process, breathing air) and other process gases (Nitrogen, CO2, Oxygen) to ensure purity for their intended use.
Oil & Hydrocarbon Content: Critical for preventing product contamination.
Moisture Content & Dew Point: Ensures air is dry enough to prevent microbial growth and corrosion.
Purity Analysis: Testing for contaminants like Carbon Monoxide (CO), Carbon Dioxide (CO₂), Sulphur Dioxide (SO₂).
Non-Viable Particle Count: Verifying the effectiveness of in-line filtration.
Microbiological Testing: For compressed air in direct product contact (aseptic operations).
Our Validation Approach
Our methodology is rigorous, transparent, and fully documented.
Design Qualification (DQ): We review system design against URS and regulatory requirements.
Installation Qualification (IQ): We verify correct installation, including materials of construction, slope, pressure ratings, and compliance with P&IDs.
Operational Qualification (OQ): We test system functions, controls, alarms, and standard operating procedures (SOPs) to ensure operational reliability.
Performance Qualification (PQ): We demonstrate the system can consistently produce and deliver the utility that meets all quality attributes under actual operating conditions. This includes sustained monitoring.