Clean Utilities Calibration

Precision calibration services for pharmaceutical, biotech, and food industry clean utilities systems

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Clean Utilities Systems We Calibrate

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Water Systems

Purified Water (PW), Water for Injection (WFI), and Highly Purified Water (HPW) systems including conductivity, TOC, and bioburden monitoring.

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Steam Systems

Clean Steam and Pure Steam generation systems with temperature, pressure, and quality monitoring instrumentation calibration.

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Compressed Air

Oil-free compressed air systems including dewpoint, particle count, and microbial monitoring instruments.

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Nitrogen Systems

High-purity nitrogen generation and distribution systems with purity analyzers and flow monitoring equipment.

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CIP/SIP Systems

Clean-in-Place and Sterilize-in-Place systems including temperature, conductivity, and flow instrumentation.

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Utility Monitoring

Continuous monitoring systems for water quality parameters, microbial detection, and environmental conditions.

Our Clean Utilities Calibration Process

1

System Assessment

Comprehensive evaluation of your clean utilities infrastructure and critical control points

2

Risk Analysis

Quality risk management approach to identify critical instruments and calibration frequencies

3

Calibration Execution

Precise calibration using NIST-traceable standards with minimal system disruption

4

Documentation

Complete calibration certificates and compliance documentation for regulatory submissions

Why Choose Our Clean Utilities Services

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Regulatory Expertise

Deep understanding of FDA, EMA, and ICH guidelines for pharmaceutical utilities

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Data Integrity

ALCOA+ compliant documentation and electronic record management

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Minimal Downtime

Efficient calibration procedures designed to minimize production impact

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Trend Analysis

Historical data analysis and predictive maintenance recommendations

Regulatory Compliance Standards

FDA

FDA 21 CFR Part 11

Electronic records and signatures compliance

USP

USP Standards

Water quality and pharmaceutical compendial requirements

ISO

ISO 17025

Testing and calibration laboratory competence

GMP

cGMP Guidelines

Current Good Manufacturing Practice compliance

ISPE

ISPE Guidelines

International Society for Pharmaceutical Engineering standards

NIST

NIST Traceability

National Institute of Standards and Technology traceable calibrations

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