Table of Contents Examples for ordering ....................................................................................... 9 Dissolution Dissolution Testers (USP apparatus 1, 2, 5 and 6) ERWEKA DT 820 6, 7 and 8 stirrer type, 1000 ml versions ...............................................10 ERWEKA DT 826 ............................................................................................................. 11 ERWEKA DT 827 .........................................................................
Dissolution Offline Kits Budget Kit ....................................................................................................36 Base Kit ........................................................................................................37 Precision/lq Kit.............................................................................................39 Precision/hq Kit ...........................................................................................41 Fast Kit .........................
RoboDis RoboDis ........................................................................................................67 1. Base Unit ...................................................................................................................... 68 2. Options ......................................................................................................................... 68 3. Extensions ........................................................................................................
Dissolution System (Closed-Loop Offline) ERWEKA Dissolution Offline Systems ......................................................87 1. Autosampler ................................................................................................................. 87 2. System control ............................................................................................................. 87 3. Peristaltic Pump ................................................................................................
ERWEKA ZTm 320 series ..........................................................................101 1 test station, type ZT 321 .............................................................................................. 101 2 test stations, type ZT 322 ............................................................................................ 101 3 test stations, type ZT 323 ............................................................................................ 101 4 test stations, type ZT 324 ....
Qualification ...............................................................................................126 Qualification documents for Tablet Hardness Testers ................................................... 126 Qualification tools for Tablet Hardness Testers ............................................................. 126 Calibration/Qualification tools for diameter and thickness measuring station ................ 126 Calibration/Qualification tools for weight measuring station ..................
All-Purpose-Equipment 1. Motors .....................................................................................................137 1.1. AR 403 .................................................................................................................... 137 1.2. AR 403-S ................................................................................................................. 137 1.3. AMD......................................................................................................
Inhaler Testers Metered Dose Inhalers (MDI's) .................................................................152 ERWEKA Type Dosage United Sampling App. DUSA-MDI .......................................... 152 Andersen Type Cascade Impactor App. 1 .................................................................... 152 Dry Powder Inhalers (DPI's) .....................................................................153 ERWEKA Type Dosage United Sampling App., Type DUSA-DPI .................................
Examples for ordering 1. ERWEKA Friability-/Abrasion Tester with two test stations (230V/50Hz), Friability Drum left with certificate, Abrasion Drum right without certificate, USB interface and Qualification document (IQ/OQ/PQ) 12-325-0001 11-3x5-2xxx 11-3x5-x3xx 12-325-2301 82-249-0000 86-315-9999 2. ERWEKA Dissolution Tester, Type DT 626 Low Head, with 6 test stations (1.000 ml), 230V/60Hz, with automatic USP sampling station (Teflon tubing 3.0 mm o.d.) 14-060-6001 14-06x-xx1x 14-060-6011 3.
Dissolution Tester (USP apparatus 1, 2, 5 and 6) ERWEKA DT 820 6, 7 and 8 stirrer type ERWEKA DT 820 has been designed with increased memory capacity to control complete Dissolution Offline Systems for advanced stand-alone operation. DT 820 allows storage of up to 100 product test-run parameters which can be interchanged between various DT 820’s by USB memory stick. The unit, as far as possible is made from carbon fibre to reduce any risk of corrosion.
ERWEKA DT 826 Shaft Systems 6 test stations, 2 reference positions MagniShaft or UniShaft For 6 stirring elements and holding 8x1000 ml vessel 230V/50-60Hz 115V/60Hz 127V/60Hz DT 820 is available with two different Shaft systems: 14-080-6001 14-080-6003 14-080-6004 1.) MagniShaft for magnetic connection between stirring element and drive or 2.) UniShaft for screw connection.
Options Sample Withdraw Systems Cyrillic keypad and Russian operation menu; instead Latin keypad and English / German operation menu 14-080-6005 Prepared for upgrade to Sampling Station (without automated sampling station) 14-x8x-x1xx Automated, simultaneous, tablet drop magazine; samples are automatically dropped when temperature within the USP specified range.
Titanium sampling- and replacement probes (corrosion-free) instead of stainless steel probes, at additional cost 80-090-0200 Vessel Centring Rings Cleaning reservoir (acrylic glass) with 3 separate compartments for cleaning of DT 820/720 sampling stations.
ERWEKA DT 720 6, 7 and 8 stirrer type ERWEKA DT 720 has been designed with the user in mind: instead of an extensive operation menu structure and multi-functional keys the DT 720 comes with individual displays for each test-run parameter (time, rpm, temperature). UP/DOWN buttons for fast and easy test-run parameter setting are placed. For better observation of the sample dissolving process the one-piece moulded water bath (with standard water outlet cock) is illuminated (optional).
ERWEKA DT 726 Shaft Systems 6 test stations, 2 reference positions MagniShaft or UniShaft For 6 stirring elements and holding 8x 1000 ml vessel 230V/50-60Hz 115V/60Hz 127V/60Hz DT 720R is available with two different Shaft systems: 14-070-6001 14-070-6003 14-070-6004 1.) MagniShaft for magnetic connection between stirring element and drive or 2.) UniShaft for screw connection.
Options Sample Withdraw Systems Prepared for upgrade to Sampling Station (without automated sampling station) 14-x8x-x1xx Additional Sampling Station with stainless steel sampling- and replacement tubes, Teflon tubing, without motor, for use with sampling station drive. 84-070-0115 USP/EP/JP compliant Sampling Station with automatic height adjustment of the 16 USP sampling heights. Teflon Tubing 1.6 mm o.d.
Titanium sampling- and replacement probes (corrosion-free) instead of stainless steel probes, at additional cost 80-090-0200 Vessel Centring Rings Cleaning reservoir (acrylic glass) with 3 separate compartments for cleaning of DT 720/820 sampling stations.
ERWEKA DT 720R 6 and 7 stirrer type ERWEKA DT 720R is based on the DT 720 user interface (keypad/displays), but fitted with 7 vessels (6 or 7 stirrers) in one row for easy access, e.g. for manual sample withdraw. The unit is available with video monitoring and recording for 6 test stations as well as with vessel capacities of 250 ml, 1000 ml or 2000 ml (special request).
ERWEKA DT 726R Shaft Systems 6 test stations, 1 reference positions MagniShaft or UniShaft For 6 stirring elements and holding 7x 1000 ml vessel 230V/50-60Hz 115V/60Hz 127V/60Hz DT 720R is available with two different Shaft systems: 14-050-6001 14-050-6003 14-050-6004 1.) MagniShaft for magnetic connection between stirring element and drive or 2.) UniShaft for screw connection.
Options Spare Part Kits Automated, simultaneous, tablet drop magazine for DT 720 R; Samples are automatically dropped when temperature within the USP specified range.
ERWEKA DT 720-4000 6 or 7 stirrer type ERWEKA DT 720-4000 High-Head is based on the DT 720 user interface (keypad / displays), but fitted with 7 vessels (6 or 7 stirrers) of 4000 ml capacity.
Options Vessel Support Plate External electronic temperature sensor PT 100 for display of water bath - or media temperature. Extended instrument menu for one-point calibration routine as well as calibration hard-copy documentation (when equipped with USB printer interface) 84-070-0100 USB printer interface (PCL 3) for hardcopy documentation of test-run parameters, calibration routines etc. Upgraded electronics (real time watch) and instrument menu (printer settings, time/date settings etc.
ERWEKA DT 1420 12, 13 and 14 stirrer type ERWEKA DT 1420 is based on DT 720 user interface (DT 1420i is based on DT 820 user interface), but fitted with 14 Vessels arranged in two rows (12, 13 or 14 stirrers). The DT 1420 offers the possibility for one test with 12/13/14 tablets or two tests with 6/7 tablets. This enables the user to carry out stage 2 USP tests within one bath at equal test conditions.
ERWEKA DT 1420 Shaft Systems 12 test stations, 2 reference positions MagniShaft or UniShaft DT 1420 is available with two different Shaft systems: For 12 stirring elements and holding 14x 1000 ml vessel 230V/50-60Hz 115V/60Hz 127V/60Hz 14-014-1201 14-014-1203 14-014-1204 1.) MagniShaft for magnetic connection between stirring element and drive or 2.) UniShaft for screw connection.
Options Vessel Centring Rings Automated Tablet Drop Magazine with temperature control before drop. All samples will be dropped simultaneously 84-070-0100 Vessel Support Plate External electronic temperature sensor PT 100 for display of water bath - or media temperature.
ERWEKA DT 620 High-Head 6 stirrer type, 1000 and 2000 ml version The basic ERWEKA stand-alone Dissolution Tester for all Laboratories and Universities where high quality is required but the budget is limited. The unit has the same quality than any other ERWEKA Dissolution Tester but it is downgraded in respects of comfort and electronics.
Options Vessel Centring Rings Drain valve on the bottom of the water bath 84-060-xx1x Illumination of the water bath by LEDs 14-090-6001 Vessel Support Plate Sampling and replacement probes (set of 6 probes, st.steel), fix in the media, manual height adjustment. Teflon tubing 1.6 or 3.0 mm outside diameter (High-Head version 1000 ml only) 14-06x-x6xx Paddles, Baskets, Discs for Paddle over Disc, Rotating Cylinder and Glassware please see Accessories.
Components, Pumps 1. Sample Transfer Pump 1.1. Transfer Pump IPC 8 1.2. Transfer Pump IPC 16 (8-channel Peristaltic Pump) (16-channel Peristaltic Pump) With the standard ERWEKA 8-channel Peristaltic Pump (IPC 8) the sample is taken from the test vessel and transferred to the Autosampler or flow-through cells of the spectrophotometer.
1.3. Transfer Pump, SP 725/10 1.4. Transfer Pump, SP 725/25 (7-channel Syringe Pump) (7-channel Syringe Pump) The ERWEKA 7-channel Syringe Pump, Type SP 725/10 with 10 ml syringes is the ideal media transfer pump for the Offline Dissolution Systems with collection volumes of up to 5.0 ml. The ERWEKA 7-channel Syringe Pump, Type SP 725/25 with 25 ml syringes is the ideal media transfer pump for the Offline Dissolution Systems, especially when collection of more than 5.
1.5. Transfer Pump PVP 720 (7-channel Piston Pump) 7-channel (optional 8-channel) high pressure, valve free Teflon/Ceramics Piston Pump for all Dissolutions Systems which require membrane filtration below 1 µm (dependant on the product this pump allows filtration down to 0.22µm) High dosage accuracy (± 0.5 ml) and fast operation (sampling intervals from 2 minutes) in combination with FRL 724/824 Fraction Collectors.
2. Autosampler 2.1. Autosampler, FRL 720 Valve-free Autosampler for 7-, 8 or 14 channel operation The 7-channel FRL 720 with x/y-driven sampling arm was designed for silent operation and maximum corrosion resistance. 10 ml or 25 ml glass tubes, a 1:1, 1:2, 1:5 or even 1:10 dilution can be obtained.
2.2. Autosampler, FRL 724 7-, 8- or 14-channel Autosampler with integrated valves The 7-channel FRL 724 – with one solenoid 3-way-valve per channel and x/y-driven sampling arm – was designed for silent operation and maximum corrosion resistance in combination with either the peristaltic- or piston pump for “stirrer type” dissolution testers as well as in combination with an USP 4 Offline system.
Options 3.1. Filter Changer, AFC 825 (8-channel membrane filter changer) 2.3 Racks for Autosampler Rack for 25x 8, for HPLC vials of 1.5 ml volume 81-200-0001 Rack for 25x 8, for HPLC vials of 4.0 ml volume 81-200-0002 The automated ERWEKA Filter Change Station AFC 825 was specially designed for Dissolution Offline and UV/HPLC Online Systems to change filters after or during the test run automatically. Changing filters during the test procedure (i.e.
4. Automatic pH Changer, AMC-A 7. UV-VIS Spectrophotometer (only) ERWEKA SPM-8, Dissolution ready 70-209-9000 ERWEKA SPM-16, Dissolution ready 70-209-9002 The AMC-A is a device for the automated pH change according to USP method “A” (halfchange). The accurate amount (volume) of buffer solution is dosed into the 8 glass vessels (max. 250 ml capacity) which are located inside a thermostatically heated acrylic water bath.
8. Tubing + Connectors Tubing + Connectors UV-VIS Online 70-20x-0001 Tubing + Connectors UV – VIS Dual Online 70-20x-0002 Tubing + Connectors UV – VIS Off-/Online 70-20x-0003 9.
Dissolution Offline-Kits “BUDGET” Kit (storage/doses into tubes only) For more precise dosing – after collection – the x/y driven arm moves down to a selected sample volume level and pumps back the sample above this level to the dissolution vessel (overfilling/levelling principle). The “BUDGET” Offline Kit with fixed stainless steel sample withdraw tubes to collect into glass tubes of 10 ml or 25 ml is designed to serve those customers with a limited budget and comprises of 1.
“BASE” Kit (storage/doses into tubes only) The connected pump (8-channel peristaltic pump) transfers the sample to collect from the vessel into glass tubes (10ml or 25 ml maximum capacity) positioned in the rack at the Autosampler.
Additional price for 8-channel version 15-118-xxxx Additional price for Titanium sample withdraw tubes, instead of stainless steel 15-2xx-1xxx Additional price for Titanium collection tubes in the Autosampler, instead of st.
“PRECISION/lq” Kit (storage/precision doses into tubes & HPLC vials, media replacement and HPLC vial membrane piercing) The “PRECISION/lq” Offline Kit represents the standard USP/EP compliant ERWEKA Offline system with high precision dosing (± 0.1 ml), standard media replacement, HLPC Vial membrane piercing and optional dilution function. The system comprises of: 1.) Fully USP/EP compliant sampling station with automatic sample withdraw height adjustment and 7 stainless steel (316) sample withdraw tubes 2.
Additional price for 8-channel version 15-128-xxxx Additional price for Titanium sample withdraw tubes, instead stainless steel 15-xxx-1xxx Additional price for Titanium collection tubes in the Autosampler, instead st.steel 15-xxx-x2xx Additional price for electronic temperature sensors for media temperature measurement/documentation in each test station 15-xxx-xx1x Rack for holding 25x 8 glass tubes, 10 ml 81-200-0003 Glass tubes, 10 ml (100 pcs.
“PRECISION/hq” Kit (storage/precision doses into tubes & HPLC Vials, media replacement and HPLC Vial membrane piercing) The “PRECISION/hq” Offline Kit, in contrast to the “PRECISION/lq” Kit, due to the higher capacity 25 ml syringes (dosing precision ± 0.25 ml), allows withdrawing/storing higher volume of sample within a shorter time. E.g. when more than 7 ml media has to be collected the “PRECISION/lq” Kit needs to withdraw media twice while the “PRECISION/hq” Kit can withdraw up to 20 ml at once.
Additional price for 8-channel version 15-138-xxxx Additional price for Titanium sample withdraw tubes, instead stainless steel 15-xxx-1xxx Additional price for Titanium collection tubes in the Autosampler, instead st.steel 15-xxx-x2xx Additional price for electronic temperature sensors for media temperature measurement/documentation in each test-station 15-xxx-xx1x Rack for holding 25x 8 glass tubes, 10 ml 81-200-0003 Glass tubes, 10 ml (100 pcs.
“FAST” Kit (storage/doses into tubes & HPLC vials, media replacement and HPLC vial membrane piercing) Optional the sample withdraw system can be equipped with electronic temperature sensors for each vessel to archive media temperature documentation for each test-station. The dosing-by-valves “FAST” Kit offers best possible dosing results in combination with the easy-to-use, budget 8-channel peristaltic pump in combination with short sampling intervals (from 2 minutes).
Additional price for 8-channel version 15-148-xxxx Additional price for Titanium sample withdraw tubes, instead stainless steel 15-xxx-1xxx Additional price for Titanium collection tubes in the Autosampler, instead st.steel 15-xxx-x2xx Additional price for electronic temperature sensors for media temperature measurement/documentation in each test-station 15-xxx-xx1x Rack for holding 25x 8 glass tubes, 10 ml 81-200-0003 Glass tubes, 10 ml (100 pcs.
“POWER” Kit (storage/doses into tubes & HPLC vials, media replacement, HPLC vial membrane piercing, filtration from 0.22 µm) The dosing-by-valves “POWER” Kit represents the high-end ERWEKA Offline Kit which offers features such as membrane filtration from as low as 0.22 µm, precision dosing (better ± 0.5 ml without regular pump-channel calibration/adjustment) and extremely short sampling intervals (from 2 minutes).
Additional price for 8-channel version 15-158-xxxx Additional price for Titanium sample withdraw tubes, instead stainless steel 15-xxx-1xxx Additional price for Titanium collection tubes in the Autosampler, instead st.steel 15-xxx-x2xx 7/8 channel “Double-Filtration-System” to insert membrane filters from 0.
“BASE-14” Kit (storage/doses into tubes only) The “BASE-14” Offline Kit represents the basic USP/EP compliant ERWEKA offline system for 14 test-stations where the stainless steel (316) sample withdraw tubes are driven into the media, to the exact USP/EP sampling height, only while the sample is withdrawn – not to change the hydrodynamics constantly. The “BASE-14” version allows collecting into glass tubes of 10 ml or 25ml.
Additional price for Titanium sample withdraw tubes, instead stainless steel 15-xxx-1xxx Additional price for Titanium collection tubes in the Autosampler, instead st.steel 15-xxx-x2xx Additional price for electronic temperature sensors for media temperature measurement/documentation in each test-station 15-xxx-xx1x Rack for holding 25x 8 glass tubes, 10 ml 81-200-0003 Glass tubes, 10 ml (100 pcs.) 91-200-0003 Rack for holding 17x 8 glass tubes, 25 ml 81-200-0004 Glass tubes, 25 ml (100 pcs.
“FAST-14” Kit (storage/doses into tubes & HPLC vials, media replacement and HPLC vial membrane piercing) The dosing-by-valves “FAST-14” Kit offers best possible dosing results in combination with the easy-to-use, budget 16-channel peristaltic pump in combination with short sampling intervals (from 2 minutes). Optional the sample withdraw system can be equipped with electronic temperature sensors for each vessel to archive media temperature documentation for each test-station.
Additional price for Titanium sample withdraw tubes, instead stainless steel 15-xxx-1xxx Additional price for Titanium collection tubes in the Autosampler, instead st.steel 15-xxx-x2xx Rack for holding 25x 8 glass tubes, 10 ml 81-200-0003 Glass tubes, 10 ml (100 pcs.) 91-200-0003 Rack for holding 17x 8 glass tubes, 25 ml 81-200-0004 Glass tubes, 25 ml (100 pcs.) 91-200-0004 Rack for holding 25x 8 vials, 1.5 ml 81-200-0001 Rack (cooled) for holding 25x 8 vials, 1.
“POWER-14” Kit (storage/doses into tubes & HPLC vials, media replacement, HPLC vial membrane piercing, filtration from 0.22 µm) Optional the sample withdraw system can be equipped with electronic temperature sensors for each vessel to archive media temperature documentation for each test-station. The dosing-by-valves “POWER-14” Kit represents the high-end ERWEKA Offline Kit which offers features such as membrane filtration from as low as 0.22 µm, precision dosing (better ± 0.
Additional price for Titanium sample withdraw tubes, instead stainless steel 15-xxx-1xxx Additional price for Titanium collection tubes in the Autosampler, instead st.steel 15-xxx-x2xx 14 channel “Double-Filtration-System” to insert membrane filters from 0.
“DUAL” Kit (storage/precision doses into tubes & HPLC Vials, media replacement and HPLC Vial membrane piercing- from 2 Dissolution baths) point, drop the tablets, start the stirring action etc. The “DUAL” Offline Kit is designed to collect samples from 2 independent operation dissolution testers which are running with the same product/media but e.g. with different batches. The samples from both baths are withdrawn by only one SP 725/25 syringe pump and collected into just one Autosampler.
Additional price for 2x 8-channel version 15-168-xxxx Additional price for Titanium sample withdraw tubes, instead stainless steel 15-xxx-1xxx Additional price for Titanium collection tubes in the Autosampler, instead st.
ERWEKA UV-VIS In- or Online System (analysis only) 1. Sample Transfer Pump 2. UV-VIS Spectrophotometers Shimadzu 1800 Double beam including 8 position cell changer, ready for Online Systems 1.1. Sample Transfer Pump IPC 8 (Peristaltic Pump) 230V/50 Hz 230V/60Hz 115V/60Hz 127V/60Hz With the standard ERWEKA 8-channel Peristaltic Pump (IPC 8) the sample is taken from the test vessel and injected to the flow-through cells of the spectrophotometer.
Perkin Elmer Lambda 25 Double beam including 8 position cell changer, ready for Online System including tubing and Perkin Elmer WinLab 2 Software Package 230V/50Hz 230V/60Hz 115V/60Hz 127V/60Hz 3. System Control 3.1. Disso.net Software Windows based ERWEKA Disso.net software Disso.net. Windows based CFR 21/11 compliant ERWEKA Dissolution System Software Disso.net 72-203-2001 72-203-2002 72-203-2003 72-203-2004 Recommended PC configuration: - Processor: Pentium IV 1.
Prices include: 1. ERWEKA Peristaltic Pump IPC 8 or Agilent Peristaltic Pump 2. UV-VIS Spectrophotometer incl. CellChanger, 3. ERWEKA Windows based 21 CFR 11 com- pliant Software, Type Disso.net, with Interface Boxes for control of UVVIS of ERWEKA, Perkin Elmer, Shimadzu, Analytic Jena and Agilent or Agilent Chem Station and Driver for ERWEKA Dissolution Bath 4. Computer, TFT monitor, colour printer 5. Teflon Tubing/Connector Kit and PreConfiguration 2. Cuvettes for UV-VIS With Teflon tubing (0.8 mm o.d.
ERWEKA UV-VIS Dual Online Systems (analysis for 2 independent Dissolution Testers) 1. 2 off Sample Transfer Pump, IPC 8 (Peristaltic Pump) 2. UV-VIS Spectrophotometers ERWEKA SPM double beam including 16 position cell changer and tubing, ready for Online Systems. 3. System Control ERWEKA Dissolution Software type Disso.net The ERWEKA Disso.net Software is able to run under Windows XP and Windows 7. For Dual Online System (Dissolution Testers, Sample Transfer Pumps and UV-VIS Photometer Perkin Elmer).
5. System Pre-Configuration Options Control and pre-configuration of the complete system at the ERWEKA laboratory. Control of function and numbering of all tubes and interface cables for easy connection at the customers site. 1. Cuvettes for UV-VIS (other than standard) 6. Computer 80-203-2110 80-203-2105 80-203-2102 80-203-2101 2. IQ/OQ/PVT Documents for UV-VIS Brand name computer in minitower housing • CPU Intel Pentium 4 min. 2.8 GHz • Hard disk min. 40 GB • Main memory min.
ERWEKA UV-VIS Off-/Online System (storage, media replacement, dilution and UV-VIS analysis) 1. Sample Transfer Pump, SP 825/25 (Syringe Pump) 2. Autosampler, FRL 820 The ERWEKA 8-channel Syringe Pump, Type SP 825/25 with 25 ml Syringes is the ideal Media Transfer Pump for all kind of Dissolution Systems. It offers very accurate volume flow, elimination of absorption (glass/Teflon) and high flexibility due to an electric 4-way valve at the in-/outlet of each syringe.
container by a Peristaltic Pump integrated in the FRL 820). In combination with the ERWEKA Windows based Disso.net software and an UV-VIS Spectrophotometer with Cell-Changer, the withdrawn sample can be either transferred directly from the Dissolution Tester to the UV-VIS, be stored in the tubes of the FRL 820 and later analysed or stored in tubes, automatically diluted and transferred to the UV-VIS for analyses using only one pump! 3.
1.2 Racks for Autosampler 7. Computer Brand name computer in minitower housing • CPU Intel Pentium 4 min. 2.8 GHz • Hard disk min. 40 GB • Main memory min. 512 MB • 1 serial interface • 6 USB 2.0 interfaces • 16x DVD-ROM device Operating system Windows XP, keyboard, scroll mouse, 17“ flat-screen TFT monitor. Customer specified computer, printer and monitor available on special request!!!Prices include: 1. ERWEKA Syringe Pump SP 825/25 2. Autosampler FRL 820 3. UV-VIS Spectrophotometer incl. CellChanger 4.
ERWEKA Half-Automated UV-VIS- and HPLC-Online Dissolution System “HADs” UV-VIS Online Connection In addition to the HPLC connection the ERWEKA HADs offers the possibility to include a UV-VIS Spectrophotometer (ERWEKA, Perkin Elmer, Shimadzu, Analytic Jena, Agilent) into the close-loop sample withdraw system, so i.e. between the sample transfer pump and the PEEK flow-through vial block or the PEEK flowthrough vial block and the return to the dissolution tester.
sample itself or by system errors such as coming, sticking etc. So what to do with the incorrect results? To through them and hide them from the authorities? To eliminate that problem completely the ERWEKA HADs is available with video monitoring of six dissolution vessels of one or both connected dissolution testers. The video monitoring allows recording of each testrun in combination with real-time overlapping dissolution profile to identify disturbances such as coning etc.
Full-Teflon Paddle and Shaft (one piece mould); numbered, certificate of compliance MagniShaft UniShaft 4. Filtration The kind of filtration required depends on the product to test 89-000-7001 89-010-7001 Tip Filtration by Poroplast filters (from 1 µm) attached to the sampling tube of the Sampling System comes as standard Full-Teflon Basket holder and Shafts; numbered UniShaft 84-010-6011 MagniShaft 89-000-6001 St.
Dual System Upgrade Possibility of connecting a 2nd Dissolution Tester to HADs; incl. 2nd block of sealed PEEK flow-through vials, system tubing/configuration and software upgrade.2nd Dissolution Tester and Sample Transfer Pump required! 72-211-xxxx dated HADs Dissolution software for Online UV-VIS analysis incl. protocols.
ERWEKA RoboDis Cleaning On completion of the test-run the vessels are emptied by sucking (no valves in the vessel), remaining tablet debris can be dissolved by cleaning solution or sucked out by a special sucking arm and the complete system is rinsed/sprayed by either water, hot water or a combination of cleaning solution and water. A valve allows splitting the used media into either standard waste water and contaminated waste water.
Analytics The RoboDis® offers maximum flexibility concerning the analytical method applied as well as full visual supervision of the dissolution process: - UV-VIS “in-vitro” measuring based on fiber optics (no Multiplexer used) - Online measuring based on UV-VIS and/or HPLC analysis - Measuring of calibration and control standards in case of online-operations 1. Base Unit RoboDis, Base Module with 7 test-station dissolution tester for USP 2 Paddle method.
3. Extensions Media Degassing and pre-heating automated integrated container for pre-heating and automated degassing by vacuum. 3000 Video Monitoring/Recording of Dissolution Tester 2 (6 stations).
Analytical Modules Fibre Optics UV-VIS Online Fiber Optics UV-VIS System Module in-situ measurement of the absorption (exchangeable tips for various path-length) in either one or two dissolution testers, incl. calibration and verification routine. In combination with the Video Recording/Monitoring option this Module allows to record a timelaps movie with real time dissolution result overlay.
Dissolution Accessories Glassware for Dissolution Polycarbonate, 1000 ml 85-000-2004 UV-resistant USP round-bottomed vessel with stand, made of glass, numbered with certificate of compliance, 2000 ml 80-000-1001 USP round-bottomed vessel, made of plastics, 1000 ml As of 2010 1000 and 2000 ml vessels will be delivered with integrated stand. The stand is ® made of Polyoxymethylene-Delrin and can be removed - if necessary.
Stirring Elements USP apparatus 1 (Basket) 1.
Baskets; for UniShaft & MagniShaft 90-000-6040 USP Basket mesh 40, numbered 95-000-6040 USP Basket mesh 40, numbered with certificate of compliance 90-000-6020 USP Basket mesh 20, numbered 95-000-6020 USP Basket mesh 20, numbered with certificate of compliance 90-000-6010 USP Basket mesh 10, numbered 70-000-5004 Suppository Basket, plastic 73
USP apparatus 2 (Paddle) 1.
Apparatus 5 (Paddle over Disc) USP apparatus 6 (Rotating Cylinder) UniShaft 1. MagniShaft Paddles and Shafts 81-000-9000 USP st.steel Rotating Cylinder, short version, to screw to Shaft; for Low-Head use 84-050-7002 89-050-7002 84-000-6012 Upper shaft (integrated in drive head) and lower shaft with Paddle (Teflon) for USP 5, numbered; for Low-Head use 86-000-9000 USP st.
Enhancer Cell MagniShaft Enhancer cell, Teflon Enhancer cell kit, Teflon, including 250 ml round-bottomed vessel made of glass, Teflon coated st.
Membrane Filters for Double Filtration System and AFC 825 Filter Changer Dissolution Consumables Filters for manual and automated sampling 82-085-0101 To connect to automatic sampling station of DT 90, DT 80, DT 70, DT 80, DT 700, DT 800, DT 720 and DT 820 as well as for fixed sampling tubes and manual sampling manifold.
84-096-0002 Additional st. steel sampling tube with marks and holder for High-Head Basket use. Tubing and Connectors Teflon tubing, 1.6 mm o.d., 25 m 90-200-0016 84-096-0012 Ditto., but Titanium sampling tube Teflon tubing, 3.0 mm o.d., 25 m 90-200-0030 14-096-0006 Syringe connected to stainless steel sampling probe; for High- and Low-Head use Verderprene tubing, 25 m 90-200-0020 10-096-0003 Eppendorf Sampling Pipette for Low-Head Dissolution Testers. One-hand operation PEEK Tubing, 2.1 mm o.
Qualification tools for Dissolution Testers Manual QA-Station 69-001-0011 Standard Qualification (certified) 80-124-0003 Holder for former ERWEKA dissolution tester, DT 70 / 80, DT 6 / /R to handle wobble measurement device, tachometer and spirit-level Includes: - Electronic RPM measuring unit - Horizontal measurement tool - Wobble and centricity measuring unit - Qualification tool for height of method - Digital Thermometer 99-001-0001 Electronic RPM measurement unit, contact less; including reflector ma
Dissolution Tester (USP apparatus 3 and 7) CALEVA BioDis Dissolution Tester with 6, 7 or 8 rows RRT 10 (for USP 3 use), with 6 rows, each 6 test positions + 2 reference position 230V/50Hz 72-226-0001 230V/60Hz 72-226-0002 115V/60Hz 72-226-0003 127V/60Hz 72-226-0004 RRT 10 (for USP 3 use), with 6 rows, each 7 test positions 230V/50Hz 72-227-0001 230V/60Hz 72-227-0002 115V/60Hz 72-227-0003 127V/60Hz 72-227-0004 The CALEVA RRT 10 is the perfect unit for multiple media change and complies with USP apparatus 3 a
USP 7 Options Qualification 1000 ml conversion kit Comprising of 4x 3 1000 ml vessel, 12x adaptor for rack, 12x evaporation cover and 12 adaptors for vessel 82-226-1007 IQ/OQ/PVT Document 66-121-9999 IQ/OQ/PVT tool kit, certified (includes: Digital Tachometer, Calibrated Thermometer, Steel Ruler, Stopwatch) 65-121-0000 100 ml conversion kit Comprising of 48x 100 ml vessel, 48x adaptor for rack, 48x evaporation cover and 48 adaptors for vessel 82-226-0107 Bottle (60) Chlorpheniramine Maleate
Dissolution Tester (USP apparatus 4) ERWEKA DFZ 720 ERWEKA USP apparatus 4 Flow-Through-Cell with 7 stations according to USP apparatus 4 Pump, HKP 720 The ERWEKA DFZ Dissolution Testers offer the typical advantages of USP apparatus 4 but eliminate the typical disadvantages. ERWEKA designed a new valve-free pump with automatic deaeration and volume adjustment. The valve-free ERWEKA Piston Pump HKP 720 is specially designed for the use with USP apparatus 4 Flow-Through-Cell.
Options Peristaltic Pump for Low-Flow Filters for Flow-Through-Cell Filter for USP 4; 0.7 µm; 25 pcs; 15 mm 70-212-1507 Filter for USP 4; 1.4 µm; 25 pcs; 15 mm 70-212-1514 Filter for USP 4; 0.7 µm; 25 pcs; 22 mm 70-212-2207 Filter for USP 4; 1.4 µm; 25 pcs; 25 mm 70-212-2214 Glass beads The standard ERWEKA 8-channel Peristaltic Pump for transfer of the sample from the media container through the test-stations of the Flow-Through-Cell Dissolution Tester.
80-012-0007 Set (7) of USP 12.0 mm Cell 80-012-1007 Set (7) of USP 22.6 mm Cell Media temperature measurement in each cell by integrated electronic PT 100 temperature sensors (temperature displayed and printed by Control Unit, Type SE) 10-013-xxxx Media Transfer Station, Type LMT, to create a “Closed Loop” system.
Dissolution Systems ERWEKA Dissolution System Open - Loop Offline Kit (storage and control only) 1. USP apparatus 4 Dissolution Tester 2. System Control Unit, Type SE The System Control Unit allows controlling automated Media Change Valve Unit (up to 3 media changes), HKP 720 USP 4 compliant Piston Pump and Fraction Collector FRL 704. The System Control Unit allows storing test-run parameters for up to 40 different products which may be recalled for testing.
Options 1. Racks Rack for 24x 8 HPLC vials of 4.0 ml volume 80-200-0002 Rack for 16x 8 glass tubes of 10 ml volume 80-200-0004 2.
ERWEKA Dissolution System Closed - Loop Offline Kit (to complete the DFZ Closed Loop system required one; HKP, LMT, DFZ) 1. Autosampler 3. Peristaltic Pump The ERWEKA standard USP 4 Fraction Collector, Type FRL 804 allows sampling up to 16 sampling cycles (up to 25 ml each). Via the system control unit, type SE; all sample parameters can be entered. The standard ERWEKA 8-channel Peristaltic Pump for transfer of the sample from the media container to the Flow-Through-Cell Dissolution Tester.
6. Media Transfer Station LMT Media Transfer Station, Type LMT, to create a “Close- Loop” system. Thermostatically heated water bath with 7x 1000 ml beaker glass, stand with magnetic stirrer for each beaker glass, Teflon tubing 80-012-1000 !!! Closed-Loop-Offline Kit System price includes the IPC/FRL 804/SE Kit (incl. rack for 25x 8 1.2 ml HPLC vials rack, tubing, preconfiguration).
ERWEKA Dissolution System Closed-Loop UV-VIS Online Kit (to complete the DFZ Closed Loop system required one; LMT, HKP, DFZ) 1. UV-VIS Spectrophotometer 4. System Pre-Configuration Shimadzu 1800 double beam including 8 position cell changer, ready for Online Systems excl. Cuvettes Control and pre-configuration of the complete system at the ERWEKA laboratory. Control of function and numbering of all tubes and interface cables for easy connection at the customers site. 5. Media Transfer Station LMT 2.
Options 1. UV-VIS Spectrophotometers ERWEKA SPM double beam including 8 position cell changer, ready for Online Systems. Additional price, instead Shimadzu 1701 incl. Cell Changer 230V/50Hz 230V/60Hz 115V/60Hz 127V/60Hz 8-channel Syringe Pump 8 electric 4-way valves, absorption free Hamilton syringes 25 ml Accuracy of volume 0,1 ml (25 ml syringes) RS 232 serial interface Teflon tubing 71-030-xx1x 4. Cuvettes for UV-VIS With Teflon Tubing (0.8 mm o.d.) and screwfittings.
Dissolution Media Preparation and Dosing ERWEKA MediPrep 120 Media Tank ERWEKA Media PreHeating Tank MT66, MT120, and MT160 (for connection to MediPrep 120). For your media storage ERWEKA offers tanks made of Polyethilen or st.steel (66 l, 120 l, or 160 l volume – other sizes on request.) The tanks pre-heat the media and can be moved around the laboratory on 3” diameter casters. Media is heated by means of the integrated 1.
ERWEKA MultiPrep Technical Data Display/Keypad: 4-line LCD/ Numeric touch pad with additional function keys Printer/Interface: parallel Memory: 60 methods/ 11 users Container volume: 18 litre Media types: almost all, including HCI solutions Dispencing volumes: 500ml, 750ml, 900ml, 1000ml Dispencing accuracy: +/-1% Temperature range: 30°C – 50°C Temperature accuracy: +/- 0,5°C Vacuum: max. 800 mbar Dosing: volumetric Mixing: gravimetric Preparing time for 8 x 1000ml Vessels: approx.
Chewing Gum Tester DRT - Test equipment to masticate chewing gums, especially medicated ones for the in vitro release of substances from the samples into a surrounding liquid medium. - Up and down strokes (vertical) of the lower jaw in combination with a revolving movement of the upper jaw which provides mastication of the chewing gum and at the same time an agitation of the test medium.
DRT 1 with 1 test station 230V/50Hz 230V/60Hz 115V/60Hz 127V/60Hz Options for DRT 12-091-0001 12-091-0002 12-091-0003 12-091-0004 1000 pcs. Nets, extra 82-090-0003 100 pcs.
Automatic Blasting Station Semi-Automatic Cleaning Station Measures: approx 0.6 x 0.8 m, height 0.6 m. Measures: Cylindric drum with a diameter of approx 0.6 m, height 0,3 m. A crank and gearbox is connected to the side of the drum. Demands on supply: compressed air 68 bar, 100 litres/min at 6 bar, compressor, reservoir of 50-100 litres. Power supply 100-240 VAC, 50/60 Hz, less than 1 A. Blaster sand: Aluminium dioxide 0.2 – 0.4 mm, 1.5 kg per batch of 18 pair of jaws.
Detergents Tester (Tergotometer) ERWEKA RT 700 Detergents Tester RT 700 is versatile laboratory test equipment with which the washing process of a common washing machine / dishwasher can be simulated, in order to determine different quality parameters of cleaning agents (tabs). The RT 700 is equipped with 7 test stations with 1.000 ml or 2.000 ml glass vessels and a further station into which the supply of the immersion cooler is integrated.
Disintegration Testers Options ERWEKA ZT 120 Series Basket Cleaning and Media Preheat Station (ZT 121/123 only) 11-25x-x1xx USP compliant “Quick-Clean” Basket Rack Assembly instead standard version. The “Quick-Clean” Baskets allows cleaning of the test stations from Tablet leftovers without the need of disassembling tools.
Options ERWEKA ZT 220 Series Basket Cleaning and Media Preheat Station (ZT 221/223 only) 12-25x-x1xx Basket Rack Assembly, Type “B”, with 3 test-stations 82-240-0011 In contrast to the ZT 120 series, on the ZT 220 series (available 1 to 4 test stations, operating simultaneously) the counting of the elapsed test duration is automatically started/ stopped when the arm with the basket is lowered/raised manually.
ERWEKA ZT 320 Series The ERWEKA ZT 320 Series offers individual operation of each test station. Each test-station comes with its own function keypad and LE display/s for individual programming of the testrun time. In standard configuration each test station offers manual (optional automatic) lift-in and out of the basket rack assembly on start/ completion of the pre-set run-time. An alarm can be selected to be reminded.
Options Upgrade Automated lift-In and -out of the Basket Rack Assembly/-ies on start/completion of the pre-set run-time of each test station. This option guarantees that the disintegration of the samples cannot go on when the pre-set run-time is completed Graphical display of the disintegration process of each individual sample. This addition to the ZT.
Options ERWEKA ZTm 320 Series mBasket type B instead of type A 82-231-0000 Disc Remover (“Spider-Arm”) for type A 80-270-0001 The automated ZTm 320 disintegration tester series is based on the manual ZT 320 series available with optional basket lift out feature; but is also upgradable by one or more basket rack assemblies with automated detection, controlled then via PC and the CFR 21/11 compliant ZT.net software package. Computer package; incl. colour printer 50-271-0002 Notebook, incl.
90-240-0004 St.steel ruler for control of stroke height ERWEKA PQ Tablets 95-240-0004 St.steel ruler for control of stroke height, numbered with certificate 95-270-0005 Set of 18 Distance Plates: 0.6, 1.0 and 1.5 mm (6 plates per size), certified 62-000-0006 Distance plates of sizes 0.6mm, 1.0mm and 1.
Tablet Friability-/ Abrasion Testers ERWEKA TA Series ERWEKA TAR Series Tablet Friability-/-Abrasion Testers of the TA Series comply 100% with all USP/EP requirements. The drum is turned at 25 1 rpm, the run-time can be adjusted by membrane function keys in either time or turnings. The remaining run-time as well as the actual rpm are shown at 2 LE displays. According to the latest specifications the unit is equipped with one additional switching leg to bring the drum to the 10° position.
Balances for Connection to TDR ERWEKA TDR 100 The ERWEKA TDR 100 has been designed to offer even more comfort as well as documentation. The TDR 100 is equipped with an interface to connect either Mettler AB 54 or Sartorius CP 64 balances. The test procedure is completely menu guided and test run parameters such as rpm, weight before and after the test as well as lost in percent is displayed (when a balance is connected).
Friability Drums Abrasion Drums Friability Drum, left for TA 120/220 (not for automatic emptying) 11-3x0-1xxx Abrasion Drum, left for TA 120/ 220 (not for automatic empt.
IQ/OQ/PQ documents for Friability-Abrasion Testers 66-310-9999 ERWEKA PQ Tablets IQ/OQ/PQ documents for ERWEKA TA/TAR/TDR 100 series IQ/OQ/PQ tools for Tablet Friability-/ -Abrasion Testers 60-310-0000 Qualification tool kit for TA, TAR and TDR Series, including of stop watch, electronic rpm measuring tool and reflector plates (35) 1 Bottle (75) of ERWEKA PQ Tablets with specified friability loss to check the performance of the unit, complete with certificate.
ERWEKA GTA 120 ERWEKA friability tester type GTA 120 designed for any form of tablets, granules and pellets according to the Pharm. Eur. Excellent reproducibility is possible due to the precise constancy of the input energy and due to the irrelevance of the tackiness of the test material inside the glass bottle (test station). The single glass bottle is fixed to a holder which is connected to an arm performing the shaking (oscillation) procedure as described in the Pharm.Eur.
Tablet Hardness Testers Options ERWEKA TBH 125 Diameter measurement; up to 28.00 mm; resolution 0.01 mm; accuracy +/- 0.03 mm 12-422-1000 Thickness measurement; up to 28.00 mm; resolution 0.01 mm; accuracy +/- 0.
ERWEKA TBH 225 ERWEKA TBH 225 D The new TBH 225 series is the basic hardness tester developed for those customers who require robust design, easy handling and fast Qualification without fulfilling 21 CFR 11 regulations. Since the samples are inserted into the test station manually all kind and shapes of samples can be tested. The unit is handled by a block of numeric membrane keys and the menu displayed at the illuminated full graphic LC display (240x64 dots).
ERWEKA TBH 225 TD ERWEKA TBH 225 WTD Similar to the TBH 225 the ERWEKA TBH 225 TD offers the possibility to measure with the “constant speed” and “constant force” hardness testing principles. The programme menu may select the required measurement principle within seconds. The TBH 225 TD in addition offers automatic measurement of sample diameter/length and semi-automatic measurement of sample thickness.
Options Sartorius CPA 64 balance incl. windshield and integrated calibration weight for connection with TBH 225 WTD 13-xx8-0xx6 Sartorius CPA 64 OCE balance (gaugeable) incl. windshield and integrated calibration weight for connection with TBH 225 WTD 13-xx8-0xx7 Mettler AB 54 balance incl. windshield for connection with TBH 225 WTD 13-xx8-0xx8 Extended Measuring Range, 3 - 1.
Software Special Versions ERWEKA MC.net Software Special version of ERWEKA TBH 225 for testing of compressed detergents (TABS) 12-420-9xxx The ERWEKA MC.net software is directly connected with the serial LAN interface of the TBH x25 and therefore allows PC operated external control of the Hardness-/Combination Tester as well as online storage of user management, product data, results as well as CFR 21/11 compliant Audit Trail. AutoCal 2.0 (Dynamic Calibration) The new AutoCal 2.
Options ERWEKA TBH 225 “Industrial Version” Diameter/length measurement for samples with a diameter/length of up to 28.00 mm (accuracy ± 0.03 mm), Version –D/28; 13-424-xx10 The stainless steel, dust-protected “Industrial Version” of the TBH 225 series was developed for those customers who require robust design, easy handling and fast Qualification without fulfilling 21 CFR 11 regulations. Since the samples are inserted into the test station manually all kind and shapes of samples can be tested.
ERWEKA TBH 325 ERWEKA TBH 325 D The new TBH 325 series is the hardness tester with integrated product memory for up to 20 products developed for those customers who require robust design, easy handling and fast Qualification without complying 21 CFR 11 regulations. Via the numeric membrane keypad with alphanumeric sub function the nominal hardness in combination with 2 individual plus/minus tolerances and remarks may be stored for up to 20 different products and recalled for testing.
ERWEKA TBH 325 TD ERWEKA TBH 325 WTD Similar to the TBH 325 the ERWEKA TBH 325 TD offers the possibility to measure with the “constant speed” and “constant force” hardness testing principles. The programme menu may select the required measurement principle within seconds. The TBH 325 TD in addition offers automatic measurement of sample diameter/length and semi-automatic measurement of sample thickness.
Options Sartorius CPA 64 balance incl. windshield and integrated calibration weight for connection with TBH 325 WTD 13-438-0006 AutoPosition tool not only aligns convex shaped oblongs, additionally it moves the tablets against the end point! Therefore the risk of wrong measurement results by either inaccurate manual positioning or turning of the samples is dramatically lowered. For testing of standard samples a standard test-station, without rollers, is implemented.
Software Packages WIN.print software Print software for hard-copy documentation at any network printer when TBH is connected to the computer Network via the optional Ethernet (LAN) adapter 50-431-0000 ERWEKA MC.net Software The ERWEKA MC.
ERWEKA TBH 425 ERWEKA TBH 425 D Hardness Tester for automatic measurement of up to 10 samples. Via the numeric membrane keypad with alpha-numeric sub function the nominal hardness in combination with 2 individual plus/minus tolerances (T2 = pass/fail criteria) and remarks may be stored for up to 20 different products and recalled for testing. Information such as product name and remarks can be entered similar to writing a message on a mobile phone.
ERWEKA TBH 425 TD ERWEKA TBH 425 WTD The semi-automated TBH 425 TD in addition to the standard TBH 425 offers automatic measurement of sample diameter/length and thickness by a motor-driven and calibratable electronic linear potentiometer. The unit can either fulfil a 3 parameter hard-copy print-out by a connected printer (optional) or transfer the data to a PC with the optional MC.net software. The ERWEKA TBH 425 WTD is based on the TBH 425 TD.
Options AutoCal 2.0 (Dynamic Calibration) Sartorius CPA 64 balance incl. windshield and integrated calibration weight for connection with TBH 425 WTD 13-xx8-0xx6 The new AutoCal 2.0 System is an automated calibration tool for calibration of the hardness test station without weights and without the need of external PC and software. With the new AutoCal 2.
ERWEKA TBH 525 such as product name and remarks can be entered similar to writing a message on a mobile phone. Stored product data can be transmitted via SD card or USB stick to other devices of the TBH 325/425 family. Cleaning of the unit is fast and easy: the magazine is to be removed so the complete transport way with all test stations to offer easy access to the transport way and all test station for manual cleaning.
group including additional rights for individual users etc. Since, due to CFR 21/11 users can not be deleted from the memory the MC.net software allows to switch users inactive and, on request, only to display active users. Options Diameter/Width Measurement (measuring range 0.10 to 26.00 mm with an accuracy of +/- 0.03 mm) 14-xx6-xxxx Thickness Measurement (measuring range 0.10 to 12.00 mm with an accuracy of +/0.
Function: The samples are individualised automatically by a new system for separation of the samples via an oscillating funnel and then deposited onto the weight measurement boat. From there the samples are transported to the test stations by a linear feeder which allows alignment of oblongs as well as odd shaped samples such as sugar coatings. In case of problematic samples a down holder in the hardness test station is available as an option.
Important Information - The area in front of the hardness and under the width measurement station should be always dust-free and free of damage. We recommend scheduled service (approximately every 300 operating hours) from an ERWEKA service engineer or qualified personnel - We recommend pre-adjustment with PQ tablets in our service department - The option width measurement should be always offered with the option down holder - Measuring range 3 – 500 N, optional 3 – 1.000 N, thickness up to 12.
PC in ERWEKA standard configuration (brand name PC in minitower housing, CPU Intel Pentium Dual Core 2 Duo with minimum 2.6GHz, Hard disk with minimum 250 GB, Main Memory with minimum 2048 MB, 3 serial interfaces, 6 USB 2.0 interfaces, 16x DVD-ROM device, Windows XP, keyboard, scroll mouse and 19'' flat screen TFT monitor) 80-430-0009 Options Down Holder for alignment of difficult to position samples including one universal down holding tool for oblong shaped tablets.
Calibration/Qualification tools for diameter and thickness measuring station Tablet Press Connection 82-455-0001 TabSelect (for the connection of tablet press with MC 5.1) 80-455-0002 Venturi Transport VTS-1, with interface 80-455-0003 AutoDoc Control Software package, instead MC.net software 80-421-0010 1.0 mm block, st.steel System, 85-421-0010 1.0 mm block, st.steel with certificate L 80-421-0030 3.0 mm block, st.
Hardness Test Station Static Calibration Tools ERWEKA PQ Tablets 80-420-0500 Calibration weight, 5.0 kg, class M3 85-420-0500 Calibration weight, 5.0 kg, class M1, calibrated with certificate 80-420-1000 Calibration weight, 10.0 kg, class M3 85-420-1000 Calibration weight, 10.0 kg, class M1, calibrated with certificate 1 Bottle (75) of ERWEKA PQ Tablets with specified weight, hardness, diameter and thickness to check the performance of the unit, complete with documentation.
Modular Check Weighing Systems Options for ERWEKA CWS ERWEKA CWS Three diversion flaps to sort the samples of 1 batch according to the entered tolerances (pass/fail or up to 3 individual tolerances) 10-41x-1xxx CWS Check Weighing System with 10 chamber storage magazine for 10 batches of up to 100 samples per chamber or 1 batch of up to 1.
IQ/OQ/PQ Documents for Check Weighing System, Type CWS 66-410-9999 IQ/OQ/PQ documents ERWEKA CWS for Calibration/Qualification tools for weight measuring station 85-423-0050 Calibration weight 50.0 g, class F1, calibrated with certificate 85-423-0100 100 mg weight, class F1, calibrated with certificate 85-423-0500 500 mg weight, class F1, calibrated with certificate 85-423-0001 1.
Powder and Granulate Testers – Bulk Density ERWEKA GTL ERWEKA GT The ERWEKA GTL is the basic ERWEKA unit for testing the flow characteristics of powders and granulates. It is equipped with an exchangeable stainless steel hopper (200 ml) with exchangeable outlet nozzle (3 sizes of nozzles standard: 10.0, 15.0 and 25.0 mm; 3 different sizes optional). The pre-weighed sample is filled into the hopper and a light sensor located under the outlet of the hopper measures the flow time.
ERWEKA GTB ERWEKA SMG The manual ERWEKA SMG is the unit for the reproducible determination of apparent (bulk) density which can be used with all free flowing powders or granules. According to DIN ISO 697 and DIN 53 466, the apparent density is determined by measuring the mass of powder in a receiver of known dimension after filling from a funnel of a specified shape under specified conditions.
Powder & Granulate Testers – Tapped Density ERWEKA SVM 121 and 221 ERWEKA SVM 122 and 222 The ERWEKA SVM 121 (one test station) and SVM 221 (two test stations) meet the specifications of USP apparatus 1 (stroke height 15 mm, 300 strokes per minute tapped metal on metal). The test run duration can be adjusted either in time or strokes (up to 99.999) by membrane function keys.
Glassware for SVM Series ERWEKA SVM 223 (only two test stations) All ERWEKA Glass Cylinders are with adaptor kit according to USP or EP Glass Cylinder, 100 ml 80-453-0100 Glass Cylinder, 250 ml 80-453-0250 Glass Cylinder, 500 ml including conversion plate for holder of SVM Series 80-453-0500 IQ/OQ/PQ documents Tapped Density Testers ERWEKA Tapped Density Testers, Type SVM 223 combines the two different specifications in only one unit.
Suppository Testers ERWEKA Suppository Hardness Tester, Type SBT 2 ERWEKA Circulation Heater, EST 2 230V/50Hz 230V/60Hz 115V/60Hz 127V/60Hz Suppository Hardness Tester comprising of an electrical heated chamber with a number of inserts to accept various size of suppositories. The hardness is checked by weights (included in the standard delivery range) which are added until the suppository collapses.
ERWEKA Suppository Disintegration Tester, Type ST 32 Options for PM Glass test tubes, 2g, with adaptor, for PM 30 acc. to EP App. B 81-000-1001 The ST 32 is a basic suppository disintegration tester and complies with the latest EP specifications. The unit comes with 3 test stations, either located inside a thermostatically heated 12 liter water bath. The test stations are automatically turned 180° in adjustable intervals.
IQ/OQ/PQ documents ERWEKA Suppository Disintegration Tester, Type ST 35 In contrast to the ST 32, the ST 35 comes with each test station located inside a 4 liter glass vessel (with optional magnetic stirrer) which are placed inside a thermostatically heated water bath (leak-free, double secured). The test stations are automatically turned 180° in adjustable intervals. ST 35 features an integrated "high-power" flowthrough heating system (accuracy ± 0.
All-Purpose-Equipment 1. Motors 1.1. AR 403 1.3. AMD This Drive Unit features a 230V (single phase) or 400V (three phase) asynchronous motor. It is adjustable between 46 and 410 rpm by means of a lockable hand wheel. AMD 230V/50Hz (single phase) 400V/50Hz (three phase) 230V/60Hz (single phase) 400V/60Hz (three phase) 115V/60Hz (single phase) 200V/60Hz (three phase) The sturdy ball bearing worm gear drive is completely maintenance free and provides an output torque of max. 30 Nm.
2. Attachments Universal Gear, UG Homogeniser, HO/HHO The ERWEKA Universal Gear is required for adjustment of the operation angle and for speed reduction. It is needed to operate the following attachments: KB 15/20/S, PT, DKE/S and GTE. UG For oil-in-water or water-in-oil emulsions. The mixing is done by compression by st.steel piston. The volume of the st.steel hopper is 1.5 litres. Max. output 30kg/h.
Laboratory Kneader, LK5 Filling and Dosing Machine for Liquids, FDF Two position filling and dosing machine. Precision dispensing, no-drip filling, easy adjustment of volume, quick removal of the dosing pumps and valves for cleaning, sterili-sation and space saving tabletop design. Max. Output 2.000 fillings/h. Dosing pumps for 5 - 30 ml (DP 30) and 20 150 ml (DP 150) and filling nozzles in different diameter are available. The FDF is the basic unit without pumps. Two st.
Ball Mills, KM Drum Hoop Mixer, RM For grinding crystalline materials and for mixing dry, or - under certain circumstances - moist materials. The balls are made of porcelain having a diameter from 30 to 50 mm. The drum is sealed air-tight with a lid and is delivered incl. frame for drive unit. Drum and Balls can be sterilised in water. For using the Ball Mill, a drive support is needed, which is optional available lengthened for the simultaneous use of two Mixers of the same size (KM 5 or KM 10).
Vibration Sieve Shaker, VT Reciprocating cam system. The intensity of the shaking action can be adjusted by the speed of the motor drive. Different sieve sets can be fitted to the sieve shaker. 10-521-0000 Sieve set comprising of 4 sieves (315 µm; 71 µm; 1,25 mm; 2,0 mm MW) acc. to ISO 9044, 20 cm diameter, made of st.steel, Type PS/S 80-521-0002 Cover made of stainless steel with collection vessel (A+D), d=200 80-521-2310 Sieve sets Sieve set comprising of 9 sieves (Kresner) acc.
Polishing Drum Dry Granulator, St. Steel, TG 2000 Designed for polishing of coated tablets. The interior of the drum is covered with interchangeable felt parts. The cover of the drum has a 120 mm diameter opening for control of the coating process as well as for adding polishing agent during the production process. To connect to an ERWEKA motor drive, a Universal Gear, Type UG is needed. PT 10-523-0000 Spare set of felt parts 90-523-0000 Two st.
Cube Mixers, KB Conical Mill, CM 60/UD Is a product in feed system for application for development in pharmaceutical and food industry which comminute powdery and freeflowing products by a sieve (adjustable 0.3 – 3.0 mm; perforated round holes, grater holes or square holes; see list) with fixed maximum sizes of impurity-free granule. Rotation speed (continuous 60 – 1200 revs/min) and sieve crack (standard 1.5 mm, adjustable 0.5 – 3.0 mm in 0.25 mm steps) can be varied for detailed adjustment of process.
Tablet Presses Options for Tablet Press, Type EP-1 Single Punch Tablet Press, EP-1 Measurement and display of compression force 72-xxx-1xxx Data transfer option RS 232 interface 72-531-0006 Data logging Software 72-531-0005 Standard data export via RS232 interface 82-531-0001 Support table in stainless steel; H/D/W (mm): 750/600/800 82-531-0004 Single punch and die set, 4.0 mm to 20.0 mm diameter, Type STR 1, for round tablets 72-531-0001 Single punch and die set, 4.0 mm to 20.
Options for TR-B 16 16-Station Rotary Tablet Press ERWEKA TR-B 16 Set (18) of round tooling, diameter to be agreed 80-532-0001 Set (18) of shaped tooling (oblong, oval), length/diameter to be agreed 80-532-0002 Set (18) blind Dies 80-532-0003 Open Die Feeder 70-532-xx1x Level Control Sensor in Hopper 80-532-0005 Support Table in stainless steel 80-532-0004 Table top GMP tablet press with 16 stations for production of up to 38.400 tablets/hr (effective production = 70 % max.
8-Station Rotary Tablet Press ERWEKA TR-D 8 Options for TR-D 8 Set (8+2) of round tooling, diameter to be agreed 80-533-0001 Set (8+2) of shaped tooling (oblong, oval), length/diameter to be agreed 80-533-0002 Set (10) Blind Dies 80-533-0003 Open Die Feeder 70-533-xx1x Level Control Sensor in Hopper 80-532-0005 Table top GMP tablet press with 8 stations for production of up to 19.200 tablets/hr (effective production = 70 % max. production), Tooling type EU “D” (IPT).
Accessories and Instrumentation of TR-B 16/TR-D 8 Device for upper compression force meter and recorder (upper roller). Strain-gauge load cell fitted in the shaft, which supports the upper compression roller (complete with single amplifier) to be connected to computer with software 75-532-0001 Device for lower compression force meter and recorder.
Options ERWEKA Roller Compactor RCC 100x20 Pharma Roller Compactor for dry granulation which turn powder into granules within seconds. This machine is especially designed to cater for frequent product changes and to work with small quantities of product, like 10 - 20 g batches. With a maximum throughput capacity of up to 10 kg/h this machine can also used for small scale production.
Options ERWEKA Fluid Bed System FB-05 Mobile undercarriage to place the FB-05. Table approximate dimensions: width/ depth/height: 1000mm/800mm/900mm 80-602-0005 Micro-Kit. Micro-Kit can be used for granulating and coating. Minimum batch sizes of 2,5 – 50 g can be processed.
Universal Automated Documentation for all kind of Rotary Tablet Presses Automated Quality Control For automated Quality Control the TRB 16/TRD 8 as well as any other tablet press wit single- or double outlet can be connected to the ERWEKA MultiCheck by an automatic Switch and a Vacuum Transport System. At the Windows based AutoDoc software the interval for withdraw of the tablets from the tablet press, transport to the MultiCheck and the number of samples to test is entered.
Blister Density Checker Options for VDT/S ERWEKA Vacuum Density Tester, Type VDT/S Upgraded electronic with USB printer interface for documentation of the test procedure 11-630-1xxx Qualification Tool Kit for VDT/S comprising of: - Vacuummeter Type DVR - Stop Watch 90-630-0000 Qualification Tool Kit, certified, for VDT/S comprising of: - Vacuummeter Type DVR - Stop Watch 95-630-0000 To verify the function of blister packaging machines ERWEKA offers the Vacuum Blister Density Tester, Type VDT/S.
Metered Dose Inhalers (MDI's) ERWEKA Type Dosage Unit Sampling App. DUSA-MDI Andersen Type Cascade Impactor, App. 1 The "Andersen" Type Multi-Stage Cascade Impactor Type ACI-MDI 1000 has been designed for determining the particle size (aerodynamic size distribution) of Metered Dose Inhalers (MDI's) in accordance with the specifications as laid down in USP and EP. The unit is available in two versions for operation at 28,3 litres per minute or 60 litres per minute. The ERWEKA Type Dosage Unit Sampling App.
Dry Powder Inhalers (DPI's) ERWEKA Type Dosage Unit Sampling App., Type DUSA-DPI Andersen Type Impactor, App. 3 Cascade The "Andersen" Type Multi-Stage Cascade Impactor has been designed for determining the particle size (aerodynamic size distribution) in accordance with the specifications as laid down in USP and EP. The unit is available in two versions for operation at 28,3 litres per minute or 60 litres per minute.
ASTRA Draco Multi-Stage Liquid Impinger (MSLI), Type ALI 1000 Single Stage Glass Impactor Glaxo (EP App. A) The Astra Draco Type Multi-Stage Liquid Impinger (MSLI) is a versatile five stage cascade impactor, which can be used for determining the particle size (aerodynamic size distribution) of inhalers.
Inhaler Accessories ERWEKA Vacuum Pump Type VP 1000 Testing Unit for Dry Powder Inhalations, Type TP-DGDPI 1000 The ERWEKA Vacuum Pump VP 1000 used for testing MDI's and DPI's employs a Rotary Vane Vacuum Pump rated at 250 litres/min. free air (210 Litres/min. when used with the control valve). The unit is supplied complete with an Electronic Digital Flow Meter as standard. The air-flow is adjusted by means of the screw valve on the front of the pump.
ERWEKA High Power Vacuum Pump, HVP Digital Flow Meter Type DFM Stand Alone Unit The standard pump VP 1000 rated at 250 litres/min free air (i.e., with nothing attached to it). However, this flow rate can fall dramatically when the resistance of both test device and inhaler are taken into account. For tests where the flow-rate of the standard pump is not enough to create a Sonic-Flow a second “High-Power” version of the ERWEKA Vacuum Pump, Type HPV, is available.
Options Inhaler Leak Test Kit IVIS Stage Mensuration All impactors should be periodically tested to check that there is no external leakage. Excessive leakage of air from an impactor can result in the incorrect flow rate being achieved, poor aerodynamic performance and possible loss of drug. Leak testing is a simple and effective means of checking that all the impactor components are assembled correctly and that there is no critical wear associated with the inter-stage seals.
Services Qualification/Qualification ERWEKA offers Installation Qualification (IQ), Operation Qualification (OQ) and Performance Verification (PV) documents for all its testing units. These documents allow the user to validate/ qualify the equipment independently by following the instructions and filling in the attached forms. To outsource the Qualification/Qualification procedure, ERWEKA offers installation as well as Operation Qualification and Performance Verification (IQ/OQ/PV) services on site.
Calibration Maintenance Before shipping all ERWEKA Hardness- and Combination Testers as well as all electronic temperature sensors are calibrated. The calibration documentation comes with the unit. To ensure a long lifetime for your units ERWEKA recommends regular maintenance. Dissolution Testers of the new generation are equipped with a Service Interval Display, which reminds the user every 3.000 hours of operation (stirring action), that maintenance is recommended.
Dissolution Testing – General Information Major organizations and groups that influence dissolution testing standards in the US: Official Methods of Dissolution Testing and the corresponding ERWEKA equipment: In the United States, Dissolution testing for pharmaceutical products in tablet and capsule form is required by the US Food and Drug Administration (FDA). The standards for testing are put by the US Pharmacopoeia (USP).