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New Guide on Water Compliance for Global Pharmacopeia Requirements from METTLER TOLEDO


METTLER TOLEDO Thornton has produced a guide for the pharmaceutical industry on compliance with global pharmacopeias for pharma waters. The complimentary guide covers existing regulations and new requirements for 2014.

(PRWEB) April 30, 2014

Do your current sampling and calibration methods and procedures meet global compliance regulations? In its Pharmaceutical Water Compliance guide, METTLER TOLEDO Thornton explain the requirements of USP 645 Water Conductivity and USP 643 Total Organic Carbon. Purified water, highly purified water, water for injection, and pure steam are used directly for pharmaceutical manufacturing processes and indirectly for system and equipment cleaning. Test sampling and calibration methods and procedures are critical to the monitoring and control of water quality, as well as meeting global compliance regulations.

In this free guide, we review the upcoming requirements of USP 645, USP 643, and the acceptable calibration methods and procedures that support the advantages of on-line testing.

Topics covered include:

  • USP 645 Conductivity
  • USP 643 Total Organic Carbon
  • New requirements for 2014 including: temperature and USP 1644. which expands on USP 645 and the operation, calibration, and maintenance of conductivity measurement systems
  • Validation of final rinse for clean in place (CIP)
  • Compliance with FDA 21 CFR Part 11 and EC GMP Annex 11 and the use of electronic records in lieu of paper records

The Complimentary Guide to Water Compliance for Global Pharmacopeia Requirements is available to download now.

METTLER TOLEDO Process Analytics division develops and manufactures instruments and sensors used for liquid process measurement and control in pure and ultrapure water applications, offering measurements of conductivity/resistivity, total organic carbon (TOC), pH, dissolved oxygen, dissolved ozone, oxidation reduction potential (ORP), sodium, silica, turbidity and flow. METTLER TOLEDO Process Analytics division consists of two business units, INGOLD and THORNTON, whose products are commonly used in industries such as:

  • Microelectronics manufacturing
  • Pharmaceutical and biotechnology processes
  • Power and steam generation
  • Brewing, food and beverage production
  • Chemical, gas process, mining and refining industries

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