manufacturer:       Sotax

model:                   AT 7

annotation:           Dokumente engl.

AT7 smart

•            7 stirrer stations with identical test conditions for 6 test samples and

1 placebo or blank solution.

•            Compact, space saving construction.

•            Operating conditions programmable on front key pad.

•            Protocol print of test parameters incl. temperature, rpm, sampling times on any printer.

•            Integrated vessel lids; i.e. no manual removal or positioning of vessel lids.

•            Automatically calibrated vessel centering and stirrer positions.

•            Handy feeder device for test samples and as Option staggered tablet feeding.

•            Programming for Off-live fraction collection built in.

•            RS-232-C Interface for connection to printer or for automation.

The SOTAX AT 7smart dissolution testing unit determines the speed of dissolution of tablets and capsules, etc. according to pharmacopoeia requirements. Gutstanding technical features and practical applications contribute to the worldwide success of this testing unit.

Since it takes up a minimum amount of Spate, it fits into any Standard test laboratory. Beside its exceptional user-friendliness, the equipment is particularly noted for its high manufacturing quality. The AT 7smart was developed under ISO 9001 utilising the AUTOCOMPLIANCE-1 concept.

This ensures that the time devoted to validation is significantly less than for other units. These advantages are coupled with Optimum operational safety in long-term use.

The features

The dissolution test instrument AT 7smart is the freit of SOTAX's mang years of experience in the development and manufacture of tablet dissolution test-Instruments. The AT 7smart conforms to latest USP/FIP guidelines and

can be used for dissolution tests using the USP methods 1 (backet), 2 (paddle),

5 (TDS paddle-over-disk) and 6 (TDS rotating cylinder method).

On the front Panel key pad with graphic display test paramaters like temperature, speed, tablet Teeding and sampling time may be programmed.

Integrated vessel lids ensure automatic vessel centering and precise positioning of the stirrers without additional tools. Due to the closed design loss an evaporation is <0.5% in 24 hours at 37°C.

Automation

The AT 7smart can be automated at any time. The modular concept permits substantially tailor-made automation solutions.

Hollow stirring shafts with suction opening and filier head are used for sampling purposes.

Without additional PC and software:

•            Control of automatic tablet Input at programmed time.

•            Control of off -line sampling with fraction collector for subsequent processing and analysis (e.g. Blution, HPLC, etc.).

With SOTAX advanced Tablet

Dissolution Software WinSOTAX (Windows 95/NT):

•            On-Iine system with direct photometric evaluation.

•            On-line HPLC system with injection through the SOTAX transfer Station directly into the HPLC unit.

•            Off-live system with sample collection in the fraction collector.

•            Combined on-/off-line system for direct evaluation and/or sample collection or system with multiple baths.

Validation and calibration

The SOTAX AT 7smart Dissolution Test instrument meets all requirements relating to validation, qualification and regular calibration.

With the unique Autocompliarice'11 design concept your validation time is reduced. The appropriate qualification documentation (IQ / OQ) can be supplied with Bach instrument.

Frequent Checks of the sturer height, centering, shaft wobble or sampling Position are not required. Validation and calibration are limited to the 6-month apparatus OQ/PQ defined by the FIP. Documentation relating to the regularly recurring system calibrations can be provided as well as a calibration check Set.

Validation and qualification can also be carried out in the customer's laboratory by SOTAX stall.

Technical data

Test Stands       7

Bath capacity     17.5 litte

Temperature      20 — 60°C

range                  ± 0.2°C

Speed range      30 — 250 rpm

Power                 230 V/50Hz or

Supply                110 W60 Hz

Interface             RS-232-C

Width/depth        595/520 mm

height                 420 mm

Weight ca.          35 kg

The Importance of the pump CP7

In a “flow-through” dissolution method, the pump is responsible for ensuring the most important parameter: the flow rate of the media. This flow rate must stay constant throughout the duration of the test, even in cases of back pressure created by filter resistance. The USP regulations require a sinusoidal flow profile with a pulse action of 120 +/- 10 pulses per minute.

SOTAX highly recommends the use of the SOTAX CP 7 Piston Pump, which has been specially developed for the USP 4 “flow-through” dissoltuion method. This pump is equipped with 7 valveless ceramic pump heads, insuring a very high level of reproducibility and consistency for the flow rate. This pump also fulfills another USP requirement which is to only use inert material (ceramic). Moreover, the maintenance of such a pump is considerably reduced due to the use of these valveless ceramic pump heads.

The flow rate can be adjusted from 1,5 to 35 ml/min, fulfilling the USP standard flow rate recommendations of 4,8 and 16 ml/min. The flow rate can also be automatically adjusted through the use of the WinSOTAX software (no need for manual adjustment). The most important parameter of this pump is the fact that the flow rate can be adjusted channel per channel. This feature is advantageous during the development of a USP 4 dissolution method. For example, the CP 7 allows to test the 3 recommended USP flow rates (4,8 and 16 ml/min) during the same test.

Another advantage of this pump is the automatic calibration/validation feature. For this purpose, the pump is linked to a balance (optional) and printer (optional). The pump automatically checks and adjusts its flow rate channel per channel based on user-defined volumes. The calibratin protocol is then automatically printed out.

FS 7 Filter Sation

q       Solves filter clogging or saturation problems associated with 25 mm diamter filters.

q       For use with on-line UV/VIS, off-line sample collection or on-/off-line semi-automated SOTAX dissoltuion systems, no retrofit needed.

q       “Stand-Alone” design with manual control allows uwe with other manufacturer’s dissoltuion baths with piston style pumps.

q       Uses common brand 25 mm luer-lock filters including Pall/Gelman, Millipore and Schleicher&Schuell down to 0,45 micron pore size.

q       Easy load with storage of up to 140 filters at a time and collection tray for dispensed used filters.

q       Controllable by 21 CFR Part 11 compliant WinSOTAX advanced dissoltuion software.

q       Useful for filter validations and method transfers to full automation

q       Automates filter changes after each sampling point for extended testing and media change methods.

WinSotax - Software

q       Validated Windows 2000/XP/Vista advanced dissolution software with a high level of data security.

q       Wide range of functionalities which fully complies with FDA 21 CFR Part 11 regulations

q       Convenient handling as users see only menus and dialogs which conform to their hardware configuration and user rights

q       On-line modules for UV/VIS spectrophotometric measurements with the most common Spectorphotometers and calcualtion of concentration and % dissolved including statistical functions.

q       Module for batch processing with a SOTAX AT 70smart for multiple analysis

q       Cell grouping function multiple tests and virtual dilution.

q       Interface for pH measurements and protocolling

q       On-line standard monitoring

q       “Calibrate standard” tool for determining standards

q       Log file for all parameter with real time protocol

q       Protocol of rpm, temperature, pH including statistical functions min./max., mean and standard deviation

q       Excipient (placebo) or impurity subtraction

q       Context based on-line help system

q       Test execution Windows with real time display of tabular data or graphics and status monitors for devices

q       Single and multi-component analysis.