MedIntegrity TA-2.0 Manufacturer & Supplier

Notes From Our Technical Documentation

Conductivity Determination of Water for Pharmaceutical Use (USP 43, EP 11.0, JP 17 and ChP 2020)

USP 43 need to measure conductivity is YES USP 43 delete chemical tests is YES USP 43 three-stage determination of purified water is YES USP 43 limit of purified water (25°C) is 1.3μS·cm USP 43 three-stage determination of water for injection is YES

Technical Guide

How UV oxidation and conductivity detection measure TOC

Total organic carbon is the amount of carbon in a sample that comes from organic compounds — and in pharmaceutical water, it is the number that tells you the water system is holding its quality. The TA-2.0 measures it by UV oxidation with conductivity detection: the sample is exposed to 185 nm ultraviolet light, which oxidizes the organic carbon to CO2; the inorganic carbon (carbonate and bicarbonate) is removed or quantified so only the organic fraction is counted; and the change in the water's conductivity as the oxidation products appear is what the instrument reads as the TOC result.

Compared with wet oxidation and high-temperature combustion, the UV oxidation route is the one many pharmaceutical water programs have adopted: low energy consumption, no combustion chemistry in the machine, complete and rapid reaction, and a result you can trust at low concentrations. The TA-2.0's detection limit is 0.001 mg/L — the level at which pharmaceutical water programs actually need to see, not a general-purpose water number.

Pharmacopeial water programs, covered

Pharmaceutical water is defined by the pharmacopeias, and the TA-2.0 is aligned to the conductivity determination programs of USP 43, EP 11.0, JP 17 and ChP 2020. For USP 43, the instrument supports the three-stage determination of both purified water and water for injection, with the 25 °C conductivity limit at 1.3 µS/cm — and the chemical tests have been deleted from the USP 43 water program, replaced by conductivity as the screening tool. JP 17 requires conductivity measurement at the same 1.3 µS/cm limit for water for injection; ChP 2020 sets the purified water limit at 5.1 µS/cm (25 °C) and keeps the chemical tests in place.

The conductivity detection range is 0.055 to 8.000 µS/cm, which spans the working window of all three water types. In practice the instrument serves the water system the way the pharmacopeia asks it to: conductivity as the routine screen, TOC as the confirmation, and the record as the evidence.

Speed, range and the data behind the result

The response time is within 4 minutes — fast enough that TOC testing fits into the water system's sampling routine instead of fighting it. The measuring range is 0.001 to 1.5 mg/L (1 to 1500 ppb) with a resolution of 0.001 mg/L and an accuracy of ±3%, and the instrument accepts samples from 1 to 95 °C, so hot loop water can be tested as it comes out of the system rather than cooled first.

The instrument is developed in accordance with GAMP guidelines with full 21 CFR Part 11 compliance support, and the delivery includes the qualification documentation package — guides for IQ, OQ and PQ. History storage is five years or more, and the electronic testing record is part of the instrument, not an add-on. Power is AC 100–240 V at 50–60 Hz (120 W), the net weight is 8 kg, and the environment window is 5 to 65 °C at 25–90% relative humidity without condensation.

Why the 4-minute result fits the water routine

A water system is sampled on a schedule, and the sampling routine only works if the instrument keeps up with it. The TA-2.0's response time of within 4 minutes is the number that makes the routine fit: a set of distribution points, standards and blanks turns over fast enough that the sampling cycle does not back up behind the analysis. And because the instrument accepts samples from 1 to 95 °C, the hot loop water can be tested as it comes out of the system, without a cooling step that adds time and a handling step that adds risk.

The measuring range of 0.001 to 1.5 mg/L with a 0.001 mg/L resolution and ±3% accuracy is the working window the pharmacopeias actually test at — the 1 ppb level of purified water and water for injection, not a general-purpose water number. The 185 nm UV oxidation with conductivity detection is the route many pharmaceutical water programs have adopted for exactly this reason: low energy consumption, no combustion chemistry in the machine, and a complete and rapid reaction.