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The PTWS 120D is a 6 position, single drive compact tablet dissolution testing instrument for solid dosage forms as described in USP chapter <711/724> and EP section<2.9.3/4> as well as the DAB and Japanese Pharmacopeia section <15>.
User Interface
In keeping with our cutting edge design, a large color, touch screen allows control of the various mechanical features of the instrument such as the tool stirring speed, lift drive and heater. The instrument control is menu driven using a resistive touch screen and selection wheel technology.
Visual signals on the display inform the user of the status of critical instrument parameters, e.g. bath target temperature not reached. Access to the instrument can be password controlled if required. If certain operational parameters form a regular feature of the daily routine, then these can be incorporated into a test method for faster set up.
These parameters can be tool speed, target bath temperature, sampling time points and so on. The test method memory capacity is almost limitless. As soon as the test is started, a screen saver can be activated with the most important information displayed in large script so that this information remains visible even at time when the operator is not standing directly in front of the instrument.
Stirring Tools
The PTWS 120D uses the Pharma Test MonoShaft™ design. Tools consist of the main shaft plus interchangeable tool heads (adapters). The main shaft remains in place in the instrument regardless of the tool head being used.
The clearance of each tool from the vessel base will always be correct once the main tool shaft has been installed and qualified with any one of the tool sets once. Each stirrer can be raised by hand into a convenient position for easy vessel removal or insertion.
Vessel Centering System
The PTWS 120D features a rigid and precise three-point individual centering system for each dissolution vessel (picture shows view from below). The vessels are held in position by three adjustable noses and are inserted into the instrument support framework.
The access points for sampling as well as the openings for the tools are contained in an auxiliary, low evaporation, vessel cover. Each USP Borosilicate glass vessel has a batch code on top of the flange for easy visibility and positioned placement inside the water bath cover.
Look on the head of the PTWS 120D with its lift mechanism
Lift Mechanism
The upper drive is motorized and electronically controlled it offers eight programmable positions: an upper cleaning and instrument qualification position and lower working positions are programmable depending on the type of stirring tool used.
The upper position offers ideal access to the stirring tools and vessels for a change of tools and cleaning steps between the dissolution tests. The motorized drive head lifting mechanism is positioned in a way so that the tool shafts are always kept parallel and at a 90° angle to the vessel walls when in the working position.
Heating System
The heating system is contained in a separate stainless steel housing. The connections between the heater and the bath are made by “quick connect fittings” for easy connection and disconnection. Water is pumped through the system using a powerful, yet quiet, circulation pump.
The pump itself is spring mounted (to limit vibration transmission) and the flow-through heater is protected from overloading (overheating in case of control electronics failure) via a thermal fuse as well as a thermo switch for added security. With service and maintenance in mind, access to the compact pump and heater section is easily achieved without having to move the main body of the instrument.
Easy access for manual sampling
Vacuum-Moulded Water Bath
The vacuum molded water bath can easily be removed from the support frame for cleaning purposes. The water bath contains a water diffuser for faster heating and to ensure that heated water is evenly distributed throughout the whole bath. The bath is double walled to reduce the heat transfer to the outer environment saving internal heating and external cooling.
Space Requirements
A key point in today’s crowded labs is the footprint of the PTWS 120D. The space saving design of the PTWS 120D offers the user the choice between a 2×3 or a 3×2 configuration with a minimal space requirement of just 45cm by 65cm (width by depth). The display module can be mounted either of two positions on the drive head of the PTWS 120D instrument.
Features
>> Automated temperature check and log at all sampling times
>> Fully USP <711/724> and EP <2.9.3/4> compliant
>> 6 stirred positons, excellent access to all vessels
>> Store a practically unlimited number of different test descriptions (methods) on SD card
>> CS 3-point individual vessel centering system
>> Centrally located electronic lift drive
>> Staggered start capability
>> Options – PT-RP8 report printer
>> Interfaces – RS-232 to connect report printer, I/O port for remote control in offline automated applications
PTWS 820-MA
8-Position USP/EP Tablet Dissolution Testing Instrument with Media Addition Station
The Pharma Test media addition station PTWS 820-MA together with the PTWS 820D tablet dissolution testing instrument can be used to perform the automated media half change for delayed release dosage forms. The operation is performing according to the requirements from USP <711>, EP <2.9.3> and CP <931> for delayed release dosage forms (in CP, enteric coated dosage forms). The test will start with 750ml of 0.1N HCl. After 2 hours, 250ml of concentrated, pre-heated buffer solution will be dosed quickly into the dissolution vessels. The pH will change to 6.8 and the dosage form should then start to dissolve.
PTWS 820-MA Media Addition System in Combination with the PTWS 820D Dissolution Bath
Fully Compliant
Pharma Test has designed the automated media change station PTWS 820-MA which can pre-heat and dose 250ml of concentrated buffer very quickly and simultaneously to the vessels of the PTWS 820D. A heated waterbath is used to pre-heat the concentrated buffer solutions in individual glass vessels. The correct temperature is important, as the amount of liquid added to the vessel is about 250ml. The temperature in the test vessels has to stay within the USP range of 37+/-0.5°C at all times. Therefore the added media should be heated up to 37 °C as well, as the addition of cold media would signifcantly affect the temperature in the test vessels. This way the test can continue immediately as required by USP, CP and EP. It is also possible to operate the whole system via the WinDiss ARGUS dissolution software.
Direct Delivery of the Additional Media Inside the Dissolution Tester
Features
Automated temperature check and log at all sampling times
Fully compliant with USP <711>, EP <2.9.3> and CP <931> recommendations for delayed release testing
For automated operation of USP, EP and CP dissolution test for delayed release (CP enteric-coated preparations) dosage forms
Unattended operation for the media change. Saves time. Customers can start the dissolution test in the evening. Not necessary to wait for the 2h.
Very fast buffer adding (less than 30sec for 250ml). Corresponds to a pump flowrate of 500ml/min. According to USP <711> and EP 2.9.3 the test must be “proceeded immediately” after the 2h in 0,1N HCl. “all test times stated are observed within a tolerance of +/-2%”.
Includes an additional heating system which will preheat the buffer. The concentrated buffer (6x250ml) must be preheated to keep in the USP Tolreance of 37 +/-0.5°C
No temperature change in the dissolution vessel as the preheated buffer will be transferred very quickly.
6 vessels are simultaneously filled with the concentrated buffer. No time gap.
No Pumps are used
Gravity and a valve system are used for the fast media dosing
The valves will automatically open after 2h
The system can be operated by WinDiss ARGUS dissolution PC software
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