RRT 10 BioDis Multiple media pH-change dissolution testing for USP 3 and 7 Multiple media pH-change testing with a touch Adjustable to your needs: USP 3 or 7 The RRT 10 is available as a fixed USP 3 or USP 7 device. If you need to test both methods, the user changeable USP 3 & USP 7 combination device is the right choice. With the ERWEKA RRT 10, automatic dissolution testing of different extended and sustained release dosage forms has become easi-er than ever before. This unit is perfectly suited for simulating the pH-changes within the human body. By placing different media in each row, the device echoes varying in vivo gastrointestinal condi-tions of the body. An automatic sample transport between the rows allows the reliable testing of the extended or sustained release from different dosage forms in various pH-zones. The simple to program RRT 10 thus, is the perfect unit for multiple media pH-changes for Touch display for comfortable control IV/IVC testing and dissolution profiling of a variety of release dosage The detachable touch display allows easy and convenient forms (e.g. tablets, coated tablets and oblongs). control of the device. It is equipped with advanced user man-agement, broad documentation features, stores up to 100 The RRT 10 is 100 % compliant to the USP/EP/JP standards and products, media and methods and stores the last ten test available as either USP method 3, USP method 7 or as a combina-protocols. tion device of both USP methods 3 and 7. It comes with an external flow-through heater, which minimizes vibrations to the device. Moreover, the unit offers a mobile touch display, which is easy to use and provides convenient control. Vessels are placed inside an acrylic water bath with an outlet valve for easy cleaning and the automatic cover system of the RRT 10 reduces media evaporation. Automated evaporation cover Three configurations available: The evaporation cover automatically closes unused vessel rack rows to reduce media evaporation. USP 3 Dissolution Tester RRT 10 ■ Configuration for USP 3 means the shafts dip by 100 mm again and again. Only reciprocating cylinder tool is available. USP 7 Dissolution Tester RRT 10 ■ Configuration for USP 7 uses a shorter dip length of 20 mm. Different tools are available. Combination of USP 3 & USP 7 External flow-through heater ■ With a few simple steps, the RRT 10 can be easily swit-The industry-proven external ERWEKA flow-through heater ched by the user from USP 3 to USP 7 or vice versa. guarantees a constant temperature with a heating range of 30° to 50° celsius with an accuracy of 0.02 °C. RRT 10: Overview RRT 10 Intuitive menu operation via touch display Highlights The ERWEKA RRT 10 is available with eight vessel racks, six (or seven) test stations and two reference positions. It is offered with a wide range of vessel versions and provides the flexibility to use 50 ml, 100 ml, 300 ml (standard) and 1000 ml vessels. An automatically running transport and a quick coupling on the tools allow for a fast exchange of samples. Together with additional features as the PT 100 temperature sensor and the USP printer and LAN interface, the RRT 10 thus is a comprehensive package for USP method 3 and USP method 7 testing. RRT 10 touch display Touch display benefits Highlights During the development of the ERWEKA RRT 10 touch display we focused on the features which users find most important: Easy and ■ Intuitive navigation due to a user-friendly menu structure ■ Automated multiple pH-change, e.g. for IV/IVC testing fast creation of methods, quick launching of tests and documenta- ■ Memory for saving up to 100 methods, media and ■ 8 vessel racks tion of test runs. The intuitive portable colour-touch display enables products each ■ Portable touch display with intuitive operation easy operation of all functions. ■ Support for currently up to 20 users (in future: 50 users) ■ Simple and quick switch from USP method 3 to USP ■ Automatic storing of the 10 latest test protocols method 7 Safe working with extensive feature set and large storage ■ OQ functions ■ Easy testing of enteric coated formulations capacity ■ Extensive calibration and adjustment capabilities ■ Suitable for different vessel sizes: ■ 6.5” touch display 50 ml, 100 ml, 300 ml (standard), 1000 ml The RRT 10 provides a password protected access to the firmware ■ USB A and LAN printer interface ■ Two reference positions for each row with 6 (or 7) test with OQ functions and product memory. The unit is equipped with stations a memory capacity that allows the user to store up to 100 different ■ Quick coupling for fast exchange of sample tools methods/media/products as well as to access the latest ten test ■ Reduced evaporation losses due to automated cov-protocols, which can be documented by printing out the data usering system ing the USB or LAN interface. Comprehensive integrated calibration ■ Filter for glass reciprocating cylinders with different functions guarantee accurate results and document each calibra-available mesh screens tion process: High convenience combined with a broad feature set. ■ Water bath with clear acrylic glass and outlet valve for easy draining and cleaning ■ Formulation holder made of innert material, e.g. 316 stainless steel, Fluoropolymer coated ■ USP 3 cylinders automatically centred inside vessels ■ PT 100 temperature sensor for temperature checking ■ USB printer and LAN interface ■ External flow-through heater Different sizes of spring holders and other methods available for USP 7 RRT 10: Main features and touch display RRT 10 Tools and vessels for USP/EP 3 and 7 Customizable to your needs We offer different kinds of tools and vessels. Not all tools and vessels work for both dissolution methods. Here is an overview for all The ERWEKA RRT 10 is available in three configurations: As a stan-recommended tool/vessel combinations. dalone device for either USP 3 or USP 7 or as an adjustable combination device for USP 3 and USP 7. Additionally, several options for Formulation adaptor 50 ml 100 ml 300 ml 1000 ml vessels and tools are available. USP/EP 3 The three different configurations Reciprocating Cylinder - - ü ü USP/EP 7 USP 3 USP 7 USP 3 & USP 7 Reciprocating Discs Spring Holder ü ü ü ü 0.60 inch, Ø 6.35 x 15.2 mm Height of stroke 100 mm 20 mm 100 mm & 20 mm (changeable) 0.96 inch, Ø 8.38 x 24.4 mm 1.40 inch, Ø 7.87 x 35.6 mm 300 ml & 1000 ml 50 ml, 100 ml, 300 ml, 1000 ml 50 ml, 100 ml, 300 ml, 1000 ml 1.45 inch, Ø 14.7 x 36.8 mm Vessel types for reciprocating cylinder for different types of tools, for different types of tools, see next page see next page Acrylic Rod ü ü ü ü User changeable method - - ü Ø 3.175 mm Cylinder Transdermal Holder - - ü ü Ø 34.9 x 92 mm Options Reciprocating Disc ü ü ü ü 1.6 cm², Ø 14.3 mm + 4 racks with 3 test stations each for 1000 ml vessels Reciprocating Disc (USP 3) ü ü ü ü 2.5 cm², Ø 17.8 mm + 8 racks for 6 test stations for 50 - 300 ml vessels (Nifedipine) (+ 2 reference positions) Cylinder Transdermal Holder + 8 racks for 7 test stations for 50 - 300 ml vessels Reciprocating Disc - - ü ü + Different vessel sizes: 50 ml, 100 ml, 300 ml, 1000 ml 5.0 cm², Ø 26.9 mm + Evaporation covers for different vessels Reciprocating Disc - - + Vessel 50 ml for Nifedipine, amber glass & adapation ü ü 7.0 cm², Ø 31.75 mm ring for 300 ml rack + Several sample holders (see table on right) for Reciprocating Disc - - - ü both methods 10 cm², Ø 50.3 mm + IQ/OQ documents Angled Disc - - ü ü 300 ml vessel with vessel holder 1.42 inch, Ø 36.1 mm Angled Disc - - - ü 1.98 inch, Ø 50.3 mm Acryl Rod 300 ml vessel with vessel holder 1000 ml vessel with vessel holder RRT 10: Options, tools and vessels Technical Data Test stations 8 rows with 6 stations (standard configuration) and 2 vials for reference purposes or 7 test stations without reference positions Water bath Water bath of 30 litres volume, clear acrylic glass Thermostat Heating rate 1500 w, 30-50° C, accuracy +/- 0.2° C Temperature control External PT 100 temperature sensor Test vessels (standard) 300 ml USP-compliant cylindrical flat bottomed glass vessels (standard configuration) Test cylinders (USP method 3) USP-compliant glass reciprocating cylinders fitted with mesh screens of stainless steel or synthetic material (automated centring inside the vessel) Formulation holder (USP method 7) Whole range of USP-compliant holders for non-eroding formulations made of stainless steel or polytetrafluoroethylene Speed Speed adjustable from 5-40 strokes/min., accuracy better than +/- 5 % Height of stroke 100 mm (USP method 3) 20 mm (USP method 7) Evaporation Vessels protected by automated covering system Control of the unit Operation by color-touchscreen, password protected access to firmware with OQ functions and product memory Automatic vessel cover available ERWEKA GmbH Technical specifications of products described are stated without Pittlerstr. 45 E-mail: sales@erweka.com warranty and are subject to change at any time without further notice. v.1.0.4.19 63225 Langen Tel.: +49 6103 92426-200 Germany Fax: +49 6103 92426-999