Pharmaceutical Quick Link | Pharmaceutical Home | Application Notes ------------------------------------------------ Request Information Software Upgrades RELATED APPLICATIONS › Water for Injection / Purified Water (TOC) › Cleaning Validation (TOC) › Residual Solvent Analysis (VOC)

Whether TOC or VOC, Teledyne Tekmar has the best instruments for your pharmaceutical water-quality testing needs. All Teledyne Tekmar instruments come with a full complement of 21 CFR Part 11 software tools for your compliance needs.

Introduction of organic matter into water systems occurs not only from living organisms and from decaying matter in source water, but from purification and distribution system materials. A relationship may exist between endotoxins, microbial growth, and the development of biofilms on pipeline walls and biofilm growth within pharmaceutical distribution systems. A correlation is believed to exist between TOC concentrations and the levels of endotoxins and microbes. Sustaining low TOC levels helps to control levels of endotoxins and microbes and thereby the development of biofilm growth. The United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) recognize TOC as a required test for purified water and water for injection (WFI). For this reason, TOC has found acceptance as a process control attribute in the biotechnology industry to monitor the performance of unit operations comprising purification and distribution systems. As many of these biotechnology operations include the preparation of medicines, the Food, Drug Administration (FDA) enacts numerous regulations to protect the health of the public and ensure the product quality is maintained. To make sure there is no cross contamination between product runs of different drugs various cleaning procedures are performed. TOC concentration levels are used to track the success of these cleaning validation procedures especially clean-in-place (CIP).

	The Atomx VOC Sample Prep System combines an Autosampler and Purge and Trap into a single instrument for the analysis of VOCs in soils and waters. This is the first of its kind and only system that employs a unique methanol extraction automation feature for high level soils. Click here for more information on the Atomx VOC Sample Prep System
	The Torch TOC Combustion Analyzer contains a built in autosampler with three vial rack choices and PC driven control. The Torch has a calibration and Intellidilution feature which automatically dilutes over-range samples to within the working calibration range. Click here for more information on the Torch TOC Combustion Analyzer
	The Fusion utilizes a patent pending process for detection with a NDIR known as Static Pressurization Concentration (SPC) which greatly improves the accuracy and precision required for this demanding technique. Click here for more information on the Fusion
	The Stratum PTC is built on years of research and innovation to make it the most advanced Purge and Trap Concentrator on the market demonstrated by its increased lot consistency, decreased water retention and unique trap that provides unparallel performance. Click here for more information on the Stratum
	For residual solvent analyses, Teledyne Tekmar’s HT3 Static and Dynamic Headspace System affords a 100-fold increase in sensitivity over conventional headspace systems.  The HT3 is simple to implement into your existing headspace system with the proven TekLink software and even integrates seamlessly with Waters Empower software. Click here for more information on the HT3
	The Teledyne Tekmar SOLATek 72 allows for the samples to be simultaneously heated and stirred which increases the purge efficiency of the analytes. Click here for more information on the SOLATek 72