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Tell us about your water system, cleaning process, sample type, acceptance criteria, regulatory context, and timeline.
USP Water Testing.
TOC, Conductivity & Cleaning Validation Services
Compliant analytical testing for pharmaceutical water systems, cleaning efficiency studies, non-specific residue monitoring, and validation programs.
Decision-ready data for critical quality programs
TOC • Conductivity • Rinse & Swab Samples • Investigation Support
TOC
Organic residue monitoring
USP
Water program support
cGMP
Quality-focused testing
BUILT FOR QUALITY TEAMS
Analytical support for regulated water and cleaning programs
Quantum helps QA, QC, validation, manufacturing, and technical operations teams generate data that is clear, compliant, and decision-ready.
1.
TOC Analysis
Pharmaceutical water and cleaning validation support using non-specific organic residue monitoring.
2.
Conductivity Testing
Conductivity testing for Purified Water and WFI programs to assess ionic impurity control.
3.
Cleaning Validation
TOC-based monitoring for rinse & swab samples, equipment cleaning studies, & efficiency programs.
4.
Contaminants and failure analysis
Support for OOT/OOS water or cleaning results with scientific interpretation and practical next steps.
THE CHALLENGE
Regulatory scrutiny demands defensible data.
Pharmaceutical manufacturers must demonstrate that water systems and cleaning processes remain in control. A single unexpected TOC, conductivity, or cleaning validation result can create questions around product quality, manufacturing continuity, and regulatory defensibility.
You may be navigating:
USP water monitoring requirementsPurified Water or WFI qualification
TOC or conductivity excursions
Cleaning validation studies with complex residue profiles
Rinse or swab samples from shared equipment
OOS/OOT investigations requiring defensible conclusions
Service 01
Total Organic Carbon Analysis for USP Water
Total Organic Carbon (TOC) analysis is a rapid, non-specific technique required by USP <643> for monitoring pharmaceutical water systems, including Purified Water and Water for Injection. TOC is also widely used as an approved tool for cleaning validation.
By measuring total carbon from all organic compounds, TOC delivers a sensitive and comprehensive assessment of residual active pharmaceutical ingredients (APIs), cleaning agents, and potential bioburden.
TOC testing supports:
Purified Water monitoringWater for Injection monitoring
Water system qualification
Routine quality checks
Trend analysis and investigations
Rinse sample evaluation
Cleaning validation and verification programs
Service 02
Conductivity Testing for USP Water
Conductivity testing is used to evaluate ionic impurities in pharmaceutical water systems. Used alongside TOC, conductivity provides a broader picture of water system control and supports USP water monitoring programs.
Conductivity testing supports:
USP Purified Water programsUSP Water for Injection programs
Water system qualification
Routine monitoring and continued verification
Investigation of ionic contamination or process drift
Quality documentation and audit support
Service 03
Non-Specific Monitoring for Cleaning Efficiency & Cleaning Validation
Cleaning validation often requires evidence that residues have been reduced to acceptable levels. TOC can serve as a practical non-specific monitor for organic residues, especially when multiple products, degradants, excipients, cleaning agents, or process residues may contribute to the total residue burden.
Ideal for:
Rinse sample analysisSwab sample analysis
Equipment cleaning studies
Shared manufacturing equipment
Multi-product manufacturing environments
Cleaning process troubleshooting
Cleaning validation lifecycle support
BUILT FOR QUALITY TEAMS
Analytical support for regulated water and cleaning programs
Quantum helps QA, QC, validation, manufacturing, and technical operations teams generate data that is clear, compliant, and decision-ready.
Unexpected TOC result
Rapid testing and technical interpretation to support clear investigation direction.
Cleaning validation uncertainty
TOC-based non-specific residue monitoring for stronger evidence of cleaning effectiveness.
Conductivity excursion
USP water conductivity support to better understand ionic impurity risk.
Complex sample matrix
Fit-for-purpose analytical approaches for more reliable, meaningful data.
Audit pressure
Defensible documentation and quality-focused reporting to support inspection readiness.
Method suitability questions
Technical guidance for water, rinse, swab, and validation sample requirements.
APPLICATIONS
Programs and sample types we support
USP Water Programs
Purified Water monitoringWater for Injection monitoring
Water system qualification
Routine TOC and conductivity checks
Excursion and trend investigations
Cleaning Validation
Rinse recovery studiesSwab recovery studies
Equipment cleaning verification
Cleaning process development
Residue monitoring
Investigations
Unexpected TOC resultsConductivity excursions
Contamination investigations
Cleaning process failures
Root-cause support
Quality Support
Audit documentation supportMethod development support
Validation lifecycle support
Technical consultation
Decision-ready reporting
SIMPLE PROCESS
From testing need to decision-ready data
1.
Define the Need
2.
Align the Testing Approach
Our technical team helps align the analytical plan with your matrix, program goals, documentation needs, and compliance expectations.
3.
Generate Defensible Results
Receive clear, quality-focused data that supports release decisions, validation packages, investigations, and audit readiness.
FAQ
Common questions
TOC testing helps evaluate organic impurities in pharmaceutical water systems and supports routine monitoring, qualification, investigations, and ongoing verification.
Yes. TOC is commonly used as a non-specific monitor of organic residues and can support cleaning efficiency studies, rinse sample analysis, swab sample analysis, and cleaning validation programs.
Conductivity testing helps assess ionic impurities and water system control. It is commonly used alongside TOC to provide a broader quality picture for USP water.
Yes. Quantum supports method development and validation when sample matrices, residue profiles, or program requirements require a tailored approach.