MedIntegrity TA-3.0 Manufacturer & Supplier

Notes From Our Technical Documentation

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

USP43 Need to measure conductivity is YES USP43 Delete chemical tests is YES USP43 Three-stage determination of purified water is YES USP43 Limit of purified water (25°C) is 1.3 μS·cm USP43 Three-stage determination of water for injection is YES USP43 Limit of water for injection is 1.3 μS·cm EP11.0 Need to measure conductivity is YES

Technical Guide

The measurement principle, in plain terms

The TA-3.0 is a UV oxidation / conductivity detection TOC analyzer: the sample is exposed to 185 nm ultraviolet light, organic carbon is oxidized to CO2, the inorganic carbon fraction (carbonate and bicarbonate) is removed or quantified, and the instrument reads the resulting conductivity change as the TOC result. The detection limit is 0.001 mg/L, the measuring range is 0.001 to 1 mg/L (1 to 1000 ppb) with a resolution of 0.001 mg/L, and the accuracy is ±3% — the working window for pharmaceutical water at the concentration levels the pharmacopeias actually test at.

The response time is within 4 minutes, and samples are accepted from 1 to 95 °C — so the water can be tested as it comes out of the distribution loop, at temperature, without a cooling step that adds time and a handling step that adds risk. Reproducibility is within 3%, which is the number that matters when the same water is tested by two people on the same shift and the results have to agree.

Aligned to the pharmacopeial water programs

The TA-3.0 covers the conductivity determination programs of USP 43, EP 11.0, JP 17 and ChP 2020. Under USP 43 it supports the three-stage determination of purified water and water for injection at the 25 °C conductivity limit of 1.3 µS/cm; JP 17 requires conductivity at 1.3 µS/cm for water for injection (and 1.3 µS/cm for purified water); ChP 2020 sets the purified water limit at 5.1 µS/cm (25 °C) and keeps the chemical tests alongside conductivity. The conductivity detection range is 0.055 to 8.000 µS/cm, spanning all three water types.

The practical effect: one instrument serves the water system the way the pharmacopeias define it — conductivity as the routine screen, TOC as the confirmation — and the record behind each number is the evidence your quality system needs.

Cleanroom-ready, and documented for audit

The TA-3.0 is specified with a hygienic design for use in the cleanroom — the form of the instrument is as much part of the specification as the measurement range, because a TOC analyzer that lives at the water system's edge needs to be cleanable and to stay out of the way of the contamination control strategy around it. The net weight is 10.5 kg, power is AC 100–240 V at 50–60 Hz (120 W), and the environment window is 5 to 65 °C at 25–90% relative humidity without condensation.

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. Storage is rated 5 to 50 °C at 25–90%, operating humidity 25–60% without condensation — a normal water room or cleanroom edge, no special conditions.

Reproducibility: the number two people have to agree on

Water testing is usually done by more than one person on the same shift, and the results have to agree. The reproducibility figure of within 3% is the number that makes that hold: the same water, tested by two operators, comes back at the same value, so the result reflects the water and not the hand that held it. On a program that runs around the clock, that consistency is what keeps the record coherent across shifts.

The hygienic design is the other half of the cleanroom position. A TOC analyzer that lives at the water system's edge has to be cleanable and to stay out of the way of the contamination control strategy around it, and the form of the instrument is part of the specification as much as the measurement range is. At 10.5 kg with a 5 to 65 °C, 25–90% relative humidity environment window, it sits in a normal water room or cleanroom edge without special conditions.