The following methods and parameters play a central role in this context:

OC Determination:

Total Organic Carbon (TOC) measurement quantifies the organic carbon content in water to detect contamination from carbon-containing compounds. The method is based on catalytic combustion at temperatures up to 950 °C, during which carbon is oxidized to CO₂ and analyzed using an infrared detector. In the pharmaceutical industry, TOC is a critical parameter to ensure water purity and product safety, as well as to identify issues early. The method is well-established in various standards (Ph. Eur., USP) and is also suitable for cleaning validation processes.

Nitrogen Content:

For determining nitrogen content, both the Total Bound Nitrogen (TNb) analysis and the Kjeldahl method are available. TNb includes nitrate, nitrite, ammonium, and organic nitrogen compounds; it is measured through combustion and chemiluminescence, making it a quick and efficient process, especially for biological cleaning residues. The Kjeldahl procedure is a classical, monographed analytical method (Ph. Eur. 2.5.9 / USP <461>) where nitrogen is determined by digestion with sulfuric acid. It is widely used in the pharmaceutical and chemical industries, as well as in food and environmental analysis, particularly for heterogeneous or solid samples.

Cleaning Validation:

Cleaning is a critical step for ensuring product and process safety. Samples are collected either via swab tests or rinse procedures and analyzed using TOC/TNb methods or other specific techniques. Validation includes staff training, standardized procedures, and recovery studies. If necessary, analyses via liquid chromatography (LC) or gas chromatography (GC) can also be employed.

BioChem offers its customers reliable and rapid water analysis (TOC) for Water for Injection (WFI) and ultrapure water. Upon request, we also perform tests for the TNb value. Alternatively, nitrogen determination by Kjeldahl is available for raw materials or pharmaceutical samples. Our experts also support you with cleaning validation and can reliably identify and quantify solvents and residual active substances using GC and LC methods. Additionally, microbiological testing—including sterility and endotoxin testing in water—is part of our comprehensive support in qualifying your water systems.

If you need further adjustments or assistance, feel free to ask!