Examining The Role Of TOC Analyzers In The Pharmaceutical Laboratory

Total Organic Carbon (TOC) analyzers are utilized across a wide range of industries for such measures as process and water quality control, experimental research, and EPA compliance. Within the pharmaceutical industry, they serve vital roles in the manufacturing process. From inspections of the water used in drug manufacture (ultrapure water) to evaluation of cleaning effectiveness (cleaning validation), TOC analyzers are essential instruments in the pharmaceutical laboratory to ensure compliance with applicable regulations.

Compliance with regulations must be maintained throughout the different processes, which can be grouped under three general categories:

1.  Preparation (includes processing and innovation)
2. Production
3. Waste Discharge

Throughout such processes, it is required to use pharmaceutical quality water, monitor the pharmaceutical water used, and achieve the required cleaning level to avoid any cross-contamination. For these steps, the FDA does not recommend any one specific analytical technique. In fact, the FDA states that any “Specific” or “Non-Specific” analytical technique can be used, as long as the technique provides results that prove its ability to detect any contaminants that would affect the quality of the water used.