Standards Set by USP on TOC Test

TOC, short for (Total Organic Carbon), is the total amount of carbon in water dissolved and suspended organics. There are many kinds of organics in water, and different organic compounds have different carbon content. TOC is often used as one of the most important composite parameters in the assessment of water quality and an indirect measure, as carbon, of organic molecules present in high purity water.

The basic methodology of TOC test is the complete oxidation of the organics to CO2 and the measurement of this CO2.

The United States Pharmacopeia is a pharmacopeia for the United States published annually by the United States Pharmacopeial Convention, a nonprofit organization that owns the trademark and copyright. The USP is published in a combined volume with the National Formulary as the USP-NF. Standards set by USP. These standards have been accepted in more than 130 countries (regions). A limit of TOC detection was determined by USP to be 0.5 ppm or 500 ppb, based on the results of studies and an industry wide survey of pharmaceutical water systems. The relevant standards of USP on TOC controlling are also described in the ISPE Baseline Pharmaceutical Engineering Guide Volume 4: Water and Steam Systems.

USP have not prevented acceptable technologies from being used, but limit the methods to the instruments that are capable of completely oxidizing. These instruments are capable of completely oxidizing the organic molecules to Carbon dioxide (CO2) and measuring the COlevels as carbon.

Installed the Water System

In lab pure water industry, only some high-end water systems are configured with TOC monitoring, but the methods are not the same. Some adopt partial oxidation which cannot meet the requirements of USP, so the accuracy of results is doubted. Users must choose water systems that can meet the requirements of USP.

The pure water TOC test technology introduced by RephiLe in early 2017 adopts the complete oxidation method, which fully meets the requirements of USP.

The following RephiLe water systems have option to equip with TOC detection:

–       Direct-Pure Genie, a system produces Type I ultrapure water and Type II EDI pure water from tap water;

–       Direct-Pure UP with dispenser, a system produces Type I ultrapure water and RO pure water from tap water;

–       PURIST with dispenser, a system produces ultrapure water from pure water. 

In addition, any RephiLe water purification system with TOC monitoring is equipped with RephiBlue remote control system. Users can manage these water systems using their mobile devices. Connected via Bluetooth, RephiBlue App has a full visibility and control of the system. It can also send demand via email or message to designated addresses should additional help is needed.

About RephiLe:

RephiLe Bioscience Ltd. is a global company that designs and manufactures innovative and high quality purification based products for biotechnology and life science laboratories. Our offering includes pure water systems and consumables, and other filtration and purification based products. Our water technology platforms include the most advanced technologies and continuous electro-deionization (CEDI) technologies to meet the needs of various laboratories and pilot production requirements: high product water quality that meets or exceeds ASTM, CLSI and CAP standards, stable performance, easy to manage at economical.

Our customer base encompasses government certification agencies, QC labs and GMP plants of pharmaceutical companies, laboratories in research institutes and universities, hospital laboratories, and environmental testing facilities. We look forward to serving our customers´ future needs with an ever-expanding range of products and services. 

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