- Testing Types
- TOC Analysis Testing
Terms and Conditions
Sample Submission Form
Overview
Total Organic Carbon (TOC) is a measure of the organic carbon present in a sample and is widely used as an indicator of organic contamination in pharmaceutical water systems and manufacturing processes. At PLS Analytical, TOC assessments help manufacturers monitor system cleanliness, evaluate water quality, and support effective contamination control.
PLS Analytical performs TOC analysis to quantify organic carbon in pharmaceutical water systems, cleaning validation samples, rinse waters, and other process samples. Using validated analytical methods, our testing supports Purified Water (PW), Water for Injection (WFI), manufacturing equipment monitoring, quality control, and ongoing process verification.
Organic contamination can originate from water systems, cleaning processes, manufacturing equipment, or process materials, making routine monitoring essential for maintaining product quality and operational control. TOC analysis provides a rapid, sensitive measure of overall organic cleanliness, helping manufacturers identify process deviations before they affect manufacturing performance.
PLS Analytical delivers scientifically robust TOC testing aligned with USP <643>, FDA cGMP requirements, and global regulatory expectations, helping manufacturers strengthen contamination control programs, maintain water system integrity, and generate reliable data for quality assurance and regulatory compliance.
Testing Services
PLS Analytical performs TOC analysis to support pharmaceutical water systems, cleaning validation programs, equipment cleanliness verification, and routine quality monitoring activities. Testing approaches can be selected based on the application, monitoring frequency, and regulatory requirements of the program.
Pharmaceutical Water TOC Testing
Pharmaceutical Water TOC Testing
Pharmaceutical water TOC testing evaluates organic contamination levels in Purified Water (PW) and Water for Injection (WFI) systems. Scientifically robust data supports routine water quality monitoring, utility system qualification, process control, and regulatory compliance.
Cleaning Validation TOC Analysis
Cleaning Validation TOC Analysis
Cleaning validation TOC analysis evaluates residual organic contamination following equipment cleaning procedures. Scientifically robust data supports cleaning validation, equipment qualification, multiproduct manufacturing, and quantitative cleanliness assessments.
Process & Investigation Testing
Process & Investigation Testing
Process and investigation testing evaluates TOC excursions, contamination events, and overall process performance. Scientifically robust data supports root cause investigations, process improvement initiatives, quality risk management, and ongoing process monitoring.
Advantages
TOC analysis delivers multiple benefits across pharmaceutical manufacturing operations by supporting water quality monitoring, contamination control, process understanding, and regulatory compliance.
Product and Process Protection
TOC testing provides a rapid indication of organic contamination that may affect water quality, equipment cleanliness, or manufacturing performance. Early identification helps prevent contamination-related quality events and supports consistent process control.
Reliable Quantitative Data
Validated TOC methods generate sensitive and reproducible measurements that support routine monitoring, investigations, cleaning validation studies, and quality reviews. Testing outputs are suitable for trending and long-term performance assessment.
Early Detection of System Changes
Routine TOC monitoring helps identify contamination events, biofilm development, cleaning failures, and utility system performance issues before they escalate into larger manufacturing or compliance concerns.
