Mettler-Toledo India Releases White Paper on Continuous Real-Time TOC Measurements & TOC Analyzer
India is having the most number of USFDA approved pharmaceutical companies outside US and more are aspiring to get USFDA approval. Water being the most widely used excipients in Pharmaceutical and Biotech manufacturing processes, USFDA mandates monitoring of TOC as specified in the monographs of the United States Pharmacopoeia (USP) and in the European Pharmacopoeia (EP) for Purified Water (PW) and Water for Injection (WFI), as well as Highly Purified Water (HPW). The USFDA’s Process Analytical Technology (PAT) initiative promotes the use of real-time measurements with the objective of ensuring good product quality. This allows Real Time Release (RTR) of product and leads to a more efficient operation.
According to this white paper, “organics are introduced into natural water systems by leachates in soil, typically from the decomposition of vegetation, animal waste and soil runoff. Organic compounds in water are a concern at all levels of water purity from potable water to pure waters used in the manufacture of pharmaceuticals. The source water used for the production of Purified Water and WFI is drinking water as indicated in the major pharmacopeia. Potable water quality can vary seasonally according to climatic changes and municipal treatment strategies, which results in varying TOC concentrations. In pharmaceutical manufacturing, organics are a contaminant to be controlled as they are a food source for bacteria in the water purification system.”
“Developed independently by METTLER TOLEDO THORNTON, the white paper takes an in-depth into the various aspects of process analytical technology, continuous measurements, real-time recovery and error to control total organic carbon improving water system performance by significant level.” said Kiran Hande, Product and Marketing Manager - Process Analytics Division, Mettler-Toledo India. “The white paper addresses the key aspects of quality and manufacturing requirements of pharmaceutical industry which are also very relevant to Indian industry to comply with its regulations.”
METTLER TOLEDO THORNTON being one of the leading manufactures of online TOC and Conductivity systems, it has been their endeavor to create awareness about the Water Testing in pharmaceutical industry according to USFDA in India in last few years. METTLER TOLEDO THORNTON had also arranged seminars in cities like Mumbai, Bangalore, Hyderabad, Ahmedabad, Vishakhapatnam and Baddi. The speaker was Dr. Anthony C. Bevilacqua, Ph.D and the ex-Chairman of the USP Pharmaceutical Water Expert Committee.
The new white paper may be downloaded from the company’s website at
About METTLER TOLEDO Process Analytics:
Within METTLER TOLEDO Group, the Process Analytics division concentrates on analytical measurement solutions for industrial manufacturing processes. The division consists of two business units: INGOLD and THORNTON, both internationally recognized leaders in their respective markets and technologies.
INGOLD is a worldwide leader in pH, Dissolved Oxygen and Gaseous Phase Oxygen, Dissolved Carbon Dioxide, Conductivity and Turbidity solutions for process analytical measurement systems in chemical, food & beverage, biotechnology and pharmaceutical industries.
THORNTON is the leader in Pure and Ultrapure Industrial Water monitoring instrumentation used in Semiconductor, Microelectronics, Pharmaceutical and Biotech applications.
About Mettler-Toledo India:
Mettler-Toledo India Pvt. Ltd., a wholly subsidiary of Mettler-Toledo Inc. (NYSE: MTD), started its operations in India in 1998. With its base in Mumbai and eleven branches across India, Mettler-Toledo India is a leading player catering to the demand of Indian industries for high-technology precision and analytical instruments used in various labs and automation processes.
Mettler-Toledo is a leading global supplier of precision instruments and is the world’s largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. Mettler-Toledo provides weighing solutions that help customers by automating processes, increasing yields, controlling product quality and complying with industry standards and regulations. Additional information about Mettler-Toledo can be found on its website www.mt.com
MHADA, Mahakali Caves Road,
Andheri (E), Mumbai
India - 400093
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