Chromatography applications:
Teledyne LABS has led the way for over 30 years in the automation of sample purification in synthetic and natural product chemistry labs as a pioneer in the research, development and manufacture of flash chromatography, preparative high-performance liquid chromatography and supercritical fluid chromatography instruments, related products and services for the purification of organic compounds in normal-phase and reverse-phase separations. You get systems that are intuitive and easy-to-use, with the highest sample recovery and a small footprint to take up little of the precious space in your lab.
Pumping applications:
Whether in the lab, through scale-up, or in production where precision dosing is required, ISCO pumps are the right choice for continuous flow pharmaceutical applications. In many chemical reactions that occur during research of new drugs, where flow rate is key to the success of the experiment, the ISCO brand of pumps are an accurate and reliable option.
- Product development — Precise fluid delivery (± 0.5% or better) to produce high-quality results
- Process development/pilot scale/production — High repeatability with pulseless flow for trouble-shooting and proof of concept
TOC applications:
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).
Sample handing/sample introduction accessories for ICP-AES and ICP-MS
With the January 2018 implementation of USP <232>/<233> testing criteria for the measurement of elemental impurities in finished drug products, manufacturers must change from traditional wet chemistry methods to recommended instrumental techniques such as inductively couple plasma atomic emission spectrometry (ICP-AES) or inductively coupled plasma mass spectrometry (ICP-MS).
Teledyne LABS offers a variety of sampling handing and sample introduction accessories for ICP-AES and ICP-MS enabling improved analysis of drug products.