Pharmaceutical Water Testing
Nordic BioAnalysis offers advanced pharmaceutical water testing services for Purified Water (PW) and Water for Injection (WFI). PW and WFI are critical in pharmaceutical manufacturing. To ensure product safety and regulatory compliance, water systems must be routinely monitored and meet strict pharmacopeial standards.
Analytical capabilities for water testing
We offer comprehensive testing for pharmaceutical-grade water, including:
- Bioburden: Quantitative assessment of viable aerobic microorganisms to verify microbial control within PW and WFI systems.
- Bacterial Endotoxins (BET): Detection and quantification of pyrogens using the Limulus Amebocyte Lysate (LAL) assay, critical for WFI testing.
- Conductivity/Resistivity measurement: Evaluation of ionic contamination (ionic purity)- the amount of dissolved ions (salts, minerals, etc.) present in the water.
- Total Organic Carbon (TOC): Assessment of organic impurities via TOC analysis to monitor system cleanliness and detect non-specific carbon-based residues.
- Nitrate testing: Quantitative determination of nitrate ions, which may indicate contamination from nitric acid or other nitrogenous compounds.
- Inorganic ions: Measurement of ions such as Ammonium, Sulfate, Chloride, Calcium, and Magnesium.
- pH-related tests (Acidity and Alkalinity): Verification of pH neutrality through acid/base titrations.
- Heavy metal testing: Detect trace levels of toxic heavy metals (e.g. lead, cadmium, arsenic, mercury) which may come from equipment corrosion, pipes, or raw water.
Our services help ensure consistent water quality throughout your production and cleaning processes.
Why water quality testing is critical in Pharmaceutical Manufacturing
Reliable pharmaceutical water testing is essential for ensuring safe, consistent, and compliant production. Regular testing of PW and WFI supports:
- Product consistency: Fluctuations in water quality can compromise drug formulation, sterility and efficacy, especially in injectable products.
- Equipment protection: Monitoring for ions and organic contaminants prevents scaling, corrosion, and premature wear on critical process equipment.
- Regulatory compliance: Routine testing ensures alignment with pharmacopoeial standards (e.g. Ph. Eur., USP) and GMP guidelines, reducing risk of audit findings.
- Cost control and efficiency: Early detection of impurities reduces downtime, lowers maintenance costs, and improves energy efficiency across water systems.
- Support for modern manufacturing: Validated, real-time water testing supports data-driven decision-making and aligns with digital quality management initiatives.
Applicable use cases
Applicable use cases
Our pharmaceutical water testing services are used across several areas:
- Microbiological methods: Including incubation conditions, contamination issues and media suitability
- System qualification (IQ/OQ/PQ) for new or modified PW/WFI systems
- Routine environmental and utility monitoring
- Batch release testing for products using WFI as an ingredient or cleaning agent
- Cleaning validation support, including final rinse water verification
- Deviation and excursion investigations, including root cause analysis and CAPA
- Re-validation and method lifecycle management when systems are upgraded or production parameters change
Each application is supported by GMP-compliant protocols and technical guidance.
Partner with a Pharmaceutical Water Testing Specialist
Strengthen your pharmaceutical water testing strategy with expert support from Nordic Bioanalysis AB. Request a tailored quotation or explore our full service offering.