MedIntegrity AIS-2.0 Manufacturer & Supplier

Notes From Our Technical Documentation

MedIntegrity AIS-2.0TOC Combination

Combination with the TOC in a fully automatic measurement system. THE OUTLOOK FOR THE AIS-2.0

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Measurement Method is Combination with the TOC Dimensions is 340 mm × 400 mm × 350 mm Weight is 8.6 Kg ( Net ) Number of vials is 20 vials

Technical Guide

What the autosampler adds to a TOC program

A TOC analyzer is only as consistent as the sampling that feeds it. Hand-injected samples bring a variable the instrument cannot fix: the human. The MedIntegrity AIS-2.0 automatic sampler removes that variable — dependable, fast and precise injections for the TOC analyzer it is combined with, so the result reflects the water and not the hand that held the vial.

The AIS-2.0 combines with the TOC analyzer in a fully automatic measurement system: the sample vial tray loads, the sampler runs the sequence, and the analyzer produces the results while the operator is doing something else. That is the difference between a water testing program that runs when someone is at the bench and one that runs on the schedule you set.

The 20-vial tray, and what it means for the routine

The sample vial tray holds 20 vials — the working set for a routine water testing program: the points on the distribution loop, the standards, the blanks, the brackets. The automatic vial tray is what allows longer unattended operation: a full set of points can run through the analyzer without an operator standing at the bench for the duration, which is the practical requirement for a water system that is sampled around the clock.

The modular design is the point of the product: the autosampler grows with the lab. Start with the tray and the analyzer, and when the program expands — more points, more frequencies — the same modular structure extends rather than being replaced. The sampler is the part of the water program that does not need to be redesigned every time the program does.

The record, unattended or not

Every run the autosampler executes is an electronic record on the analyzer: the sequence, the vial positions, the results, the time, the operator. For a water program that runs unattended, that record is what the auditor reads in place of the operator who was not at the bench — and it is structured the same way as a manually run set, so the program is one program with one record format, regardless of who (or what) ran the sequence.

The instrument is compact for what it does: 340 × 400 × 350 mm, 8.6 kg net. It sits next to the analyzer it serves, takes up the footprint of a small benchtop unit, and does the injection work that used to be the most variable part of the TOC routine.

What unattended operation changes about the program

A water system that is sampled around the clock does not wait for the bench to be free. The AIS-2.0's 20-vial tray — the points on the distribution loop, the standards, the blanks, the brackets — is what lets a full set run through the analyzer on the schedule you set, without an operator standing at the bench for the duration of the sequence. The program stops depending on when someone is available and starts running on when the system needs it, which is the position a 24-hour distribution loop actually requires.

The modular design is the other half: the autosampler grows with the lab. Start with the tray and the analyzer, and when the program expands — more points, more frequencies — the same modular structure extends rather than being replaced. The sampler is the part of the water program that does not need to be redesigned every time the program does.

The record when nobody is at the bench

For a water program that runs unattended, the record is what the auditor reads in place of the operator who was not at the bench. Every run the autosampler executes is an electronic record on the analyzer: the sequence, the vial positions, the results, the time, the operator. And because it is structured the same way as a manually run set, the program is one program with one record format, regardless of who — or what — ran the sequence.

That is the compliance shape of the instrument, sitting alongside the GAMP-aligned development and 21 CFR Part 11 support of the analyzers it feeds: the unattended result is as defensible as the attended one, because the record is the same kind of record. At 340 × 400 × 350 mm and 8.6 kg, it takes the footprint of a small benchtop unit next to the analyzer it serves, and does the injection work that used to be the most variable part of the TOC routine.

Where the autosampler sits in a qualified system

In a GAMP-aligned water program, the sampling path is part of the qualified system, and the AIS-2.0 is designed to sit inside that boundary rather than around it. Combined with the TA-series analyzer, it is a fully automatic measurement system: the tray loads, the sequence runs, the injections are dependable, fast and precise, and the results are generated whether or not someone is at the bench. The modular structure means the sampler can be added to an existing analyzer, extended as the program grows, and qualified alongside the instrument it serves.

The practical discipline the autosampler enforces is the one a water program needs: the same sequence, the same vial positions, the same results format, run after run, with the sequence, the positions and the results all recorded on the analyzer. For the distribution points, the standards, the blanks and the brackets on a 24-hour loop, that is the difference between a program that runs when the bench is free and one that runs on the schedule the system requires — with the unattended result as defensible as the attended one, because the record is the same kind of record either way.

The sequence is the procedure

A fully automatic measurement system only works if the sequence behaves like a written procedure: the same vial positions, the same order, the same standards and blanks bracketing the sample points, every run. On the AIS-2.0 that discipline is what the tray layout plus the analyzer's sequence definition gives you — the routine is defined once, and every unattended run executes the definition rather than a person's recollection of it.

The time basis is the other half of the discipline. When a water system's schedule says the loop is sampled at the distribution points on an interval, the sampler runs that interval whether or not the bench is occupied, and the record carries the sequence, the positions and the results in the order they happened. For an audit of an unattended program, that ordered record is the evidence that the schedule was kept, not an assumption that it was.