PTWS 620

USP/EP Tablet Dissolution Testing Instrument

The PTWS 620 is a 6 + 2 position, single drive 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/BP and Japanese Pharmacopeia section <15>. The USP monograph <1092/2.4.2> lists visual observation of the dissolution behavior as essential for identifying variables in the formulation or manufacturing process. The six vessels in the front row of PTWS 620 offer optimal visibility of the samples.

PTWS 620

USP/EP Tablet Dissolution Testing Instrument

The PTWS 620 is a 6 + 2 position, single drive 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/BP and Japanese Pharmacopeia section <15>. The USP monograph <1092/2.4.2> lists visual observation of the dissolution behavior as essential for identifying variables in the formulation or manufacturing process. The six vessels in the front row of PTWS 620 offer optimal visibility of the samples.

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. Status messages and color changes on the display inform the user of the status of critical instrument parameters, e.g. bath target temperature not reached.

A status bar provides a quick overview and uses the familiar traffic light system green – yellow – red. 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 620 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 fixed in its position. A wide variety of different stirring tools is available while the standard configuration includes USP/EP App. 2 Paddle stirrers.

Vessel Centering System

The PTWS 620 features a 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. Each vessel is correctly centered against the stirring tool, while this position is secured even when the vessels are removed for cleaning and placed back afterwards. The access points for sampling as well as the openings for the tools are contained in an auxiliary, low evaporation, vessel cover.

Heating System

The ultra-fast heating system is installed on an easy to remove platform within the stainless steel housing. The heat up time of the water bath has been reduced by approx. 40% compared to previous models. Access to pump, heater and all safety sensor system is possible without to move the bath from its qualified position. 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.

Automation Capabilities

The motorized EPE-620 sampling system lowers the sampling probes into the media and after sampling raises them back out again. 8 different sampling positions can be programmed. The ITM-620 individual media temperature monitoring system is attached to the EPE-620 and will read and report the vessel media temperatures while sampling.

The manual TM-620 or motorized TMA-620 tablet dropping magazine completes the set of useful accessories for automation. It covers all vessels and ensures low evaporation rates during the dissolution test. The magazines include magnetic holders for the tube cleaning device.

Offline Sampling and Sample Preparation

For offline automation with fraction collection the PTFC-2/8 fraction collector as well as either a PT-SP8 multiple syringe pump, an IPC peristaltic pump, or a CAT piston pump can be added to the PTWS 620.

Using the PTWS 620 within an automated system offers the operator full access to the vessels before and at the end of a run as the complete drive head is lifted electronically.

Sampling sequence timing is programmed using the menu system of the PTWS 620 instrument, while sampling volume and the optional media refilling process is programmed at either the PTFC-2/8 or DSR-M.