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>.
- Tablet Dissolution Testing Instruments
- Offline Automated Dissolution Systems
- Online Automated Dissolution Systems
- In-Situ Dissolution Testing (Coming Soon)
- Media Preparation
- UV/VIS Spectrometers
Tablet Dissolution Testing Instruments
A dissolution test is a means of identifying and proving the availability of active pharmaceutical ingredient (API) in their delivered form.
Offline Automated Dissolution Systems
The DFC offline semi-automated dissolution testing systems include a dissolution bath, a pump and a fraction collector which collects the sampled dissolution media.
Online Automated Dissolution Systems
Automated dissolution testing in this case means sampling, measuring, and result calculation are automated. The user adds the samples when prompted to do so by the system and takes care of filling and cleaning of the vessels.
Media Preparation
Media preparation and degassing are vital parts of a tablet dissolution test as deaerated media are critical to the reproducibility of dissolution results.
UV/VIS Spectrometers
UV/VIS Spectrometers for Tablet Dissolution Applications
PTWS 820-MA
DESCRIPTION
FEATURES
SPECIFICATION
SUPPLY SCOPE
DATA SHEET
DESCRIPTION
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.
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
Advantages
>Very fast buffer adding which 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
>Includes an additional heating system which will preheat the buffer in the USP Tolerance of 37 +/-0.5°C
>No temperature change in the dissolution vessel
>Unattended operation for the media change
SPECIFICATION
| Parameter | Specification |
| Number Vessels | 8 |
| Standard Vessels | 250 milliliter USP/EP Borosilicate glass vessel, each individually coded |
| Vessel Covers | Ultra-low evaporation design (< 0.7% within 24h) |
| Heating System | Pump for water circulation and 1500W heater for fast heating up (230/240V units only) |
| Heater Range | 25-45°C |
| Heater Accuracy | ± 0.2°C inside the water bath |
| Water Circulation | Water circulated from external heating system through special diffuser inside the water bath |
| Vibration Elimination | External heating system, spring loaded pump assembly |
| Instrument Dimensions | Bath: approx. 60cm x 25cm x 64cm (width x depth x height) Heater: approx. 26cm x 37cm x 21cm (width x depth x height) |
| Net Weight | Approx. 12kg waterbath, 5kg heater |
| Certification | All components certified to USP / EP requirements |
| CE / EMC Certification | All CE / EMC Certification provided |
| Validation | All IQ & OQ documents included |
SUPPLY SCOPE
Included in the Standard Scope of Supply
>Plexiglass water bath
>One set of 250ml Borosilicate glass vessels
>Comprehensive documentation folder including:
>>User manual
>>DQ/QC instrument compliance test certificate
>>IQ documentation
>>OQ documentation
>>Instrument logbook
DATA SHEET
PT-DR
DESCRIPTION
FEATURES
SCOPE
DATA SHEET
DESCRIPTION
Dispersion Releaser – Release Apparatus for Nano- and Microformulations
The Dispersion Releaser PT-DR is a dialysis-based apparatus for the release testing of nanomedicines, microformulations and semi-solid dosage forms within a standard dissolution tester. It is composed of a sample holder cell serving as the donor compartment for dispersed dosage forms. A dialysis membrane is disposed around this housing. This donor chamber is agitated by a paddle stirrer that is connected to the USP Apparatus 2.
FEATURES
>Providing a uniform, constant and reliable release of the active substance which leads to reproducible results
>Tube membranes with a width between 26-32 mm can be used
>Typical materials for membran are cellulose ester and regenerated cellulose
Advantages
>Reproducible release through the additional stirring movement in the donor compartment
>Increased throughput of the dialysis process
>Mixing inside the donor and the acceptor compartment for an optimal homogeneous suspension
SCOPE
Included in the Standard Scope of Supply
>PT-DR with mounting tool for the membrane (part. no. 318-5010)
DATA SHEET
PTWS 1420
DESCRIPTION
FEATURES
SPECIFICATION
SUPPLY SCOPE
DATA SHEET
DESCRIPTION
USP/EP Tablet Dissolution Testing Instrument
The PTWS 1420 is a 14+2-position, “dual 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 BP, DAB and Japanese Pharmacopeia section <15>. The instrument features 14 testing positions and includes two additional standard size vessels for media refilling and reference standard media. PTWS 1420 features independent stirrer speed control for the left and right half of stirrers.
FEATURES
>Automated temperature check and log at all sampling times
>Fully USP <711/724> and EP <2.9.3/4> compliant
>14 stirred vessel positions, 2 additional heated vessels for replacement media
>Dual drive configuration with two stirrer motors
>CAN Bus technology offering instrument suitability check prior to start of a test run
>Staggered start capability
>Vessel low evaporation sealing covers
>Removable water bath for easy cleaning
>Drainage tap to empty the bath
>Method management and user administration
>User access control
>Optical and acoustic signals to inform about sampling intervals,
>Timer count down function
>Traffic Light optical information on display shows the instrument status by different colors (green = ready to use, yellow = preparing to use, red = error encountered)
>OQ, PQ interval warning with programmable interval
>Interfaces: USB port for remote control of the PTWS 1420, RS232 port to connect serial devices, I/O port for remote control of external instruments in automated applications, like DSR-M, pumps
>Calibration menu for stirrer speed, bath temperature and moreand PTFC-16
Advantages
>14 stirred vessel in one instrument is ideal for Biowaiver applications and offline automated systems
>Dual drive configuration with independent speed control for left and right side of instrument enables flexible use of the PTWS 1420
>Replacement media is stored in two additional heated vessels eliminating influences from cold media refilling
>Easy to use auto vessel centering system
>Eco friendly double walled vacuum molded water bath for improved temperature insulation
>Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>Wake up functionality to start heating at a pre-programmed time
>Programmable infinity test
>MonoShaft™ system to avoid re-adjustment of immersion depth after tool exchange
>Staggered start feature for convenient manual sampling
>Water diffuser for even temperature distribution
>IQ/OQ documents included free of charge
SPECIFICATION
| Parameter | Specification |
| Display | 6″, 320×240 pixel color LCD, illuminated |
| Data Entry | Resistive touch screen, functional touch keys |
| Acoustic Signal | Programmable acoustic signal for operator information |
| Timer | Programmable sampling times, wake-up and sleeping mode, operation time information and timer count-down mode |
| Stirrer Position | 8 programmable stirrer immersion positions (paddle over disk, transdermal cylinder etc.) |
| Testing Method Programming | Unlimited number of different test descriptions can be stored on SD card |
| User Access Control | Multiple level access control, CFR compliant |
| OQ, PQ control | Programmable time periods to remind on QO or PQ testing |
| Printer | External PT-RP80 report printer using long-life printer paper |
| Number of Stirred Vessels | 14 vessels in a 2x 6+1 arrangement |
| Number of Additional Vessels | 2 unstirred and heated vessels to store replacement medium |
| Standard Vessels | 1 liter USP/EP Borosilicate glass vessel, each individually coded |
| Vessel Covers | Ultra-low evaporation design (< 0.7% within 24h) |
| Stirring Speed Control | 25 – 250 RPM |
| Speed Accuracy | ±2% of set speed, typically < 1% |
| Stirrer Shaft Wobble | Better than 0.2 mm total run out |
| System Tools | MonoShaft™ stirrer design, USP/EP apparatus 1, 2, 5, 6 tool adapter, cream cell, transdermal patch tools, each tool and vessel individually coded |
| Heating System | Pump for water circulation and 1500W heater for fast heating up (230/240V units only) |
| Heater Range | 25 – 45°C |
| Heater Accuracy | ± 0.2°C inside the water bath |
| Heat Up Process | Energy saving, programmable “wake up” heater function and “sleep mode” |
| Water Circulation | Water circulated from external heating system through special diffuser inside the water bath |
| Vibration Elimination | External heating system, spring loaded pump assembly |
| Calibration | Built-in calibration procedures for speed, temperature control, OQ/PQ interval programmable including alarm indicator |
| Instrument Dimensions | Bath: approx. 97cm x 69cm x 82cm (width x depth x height) Heater: approx. 26cm x 37cm x 21cm (width x depth x height) |
| Net Weight | Approx. 105 kg |
| Certification | All components certified to USP / EP requirements |
| CE / EMC Certification | All CE / EMC Certification provided |
| Validation | All IQ & OQ documents included |
SUPPLY SCOPE
Included in the Standard Scope of Supply
>One set of 14 stainless steel paddles
>One set of 16 batch coded 1000ml Borosilicate glass vessels
>One set of depth adjustment balls
>One bottle of ALGEX water preservative
>Comprehensive documentation folder including:
>>User manual
>>DQ/QC instrument compliance test certificate
>>IQ documentation
>>OQ documentation
>>Instrument logbook
>>Compliance certificates for vessels and stirring tools
DATA SHEET
WinDiss ARGUS Dissolution Software
DESCRIPTION
FEATURES
SPECIFICATION
DATA SHEET
DESCRIPTION
21 CFR Part 11 compliance as well as compliance to the new requirements for Data Integrity
The WinDiss ARGUS Dissolution Software is a scientific dissolution data management software for instrument control, data acquisition, data management, processing and reporting – designed by users for users. WinDiss ARGUS Dissolution is compatible to almost all dissolution systems in the laboratory. Just one software needs to be trained and qualified. Whether you perform dissolution tests occasionally or several times each day WinDiss ARGUS Dissolution will make you more productive in running tests and analyzing results.
FEATURES
>Connect multiple dissolution test laboratories to one central database
>ARGUS/Dissolution can be used offline to query, review, approve, release and electronically sign methods and analyses.
>Use ARGUS/Dissolution to exchange data with your LIMS or enterprise document management system (EDMS).
>Database Compatibility
>>MariaDB
>>MySQL
>>Microsoft SQL Server
>>Oracle
>Additional USP/EP compliance features:
>>One or more Q-values for each API
>>High/low dissolution boundaries
>>USP S1, S2 and S3 testing in one record
Advantages
>Instant recording of raw data
>Standard database backup and recovery procedures
>Long term persistence in XML
>Detailed audit trail for electronic records
>System log for tracking application events
>Electronic signature support
>Cryptographical record protection
>Role specific access to program functions
>IQ/OQ/PQ support with reminder function
>Built in system suitability check
>Failsafe technology for data recovery
>Full Spectrometer OQ (as outlined in USP38)
>Groupware Functionality (Enterprise Edition):
>Method deployment via shared database
>Centralized user account management
>LDAP authentication (ActiveDirectory)
>Prepared for LIMS connectivity
>Review Data through your web browser
SPECIFICATION
| Instrument Category | List of Supported Instruments |
| Drivers for Dissolution Tester | Pharma Test PTWS 120D/S, PTWS 820, PTWS 620, PTWS 1220, PTWS D620, PTWS 1420, IDS 1000, PT-DT8, PTWS 300, PTWS 310, PTWS 610, PTWS 1210, PTWS D610 Hanson SR8 Plus, Vision Elite & Classic 6, Vision G2 Elite & Classic 6 Sotax AT7/AT7smart, AT Xtend; Varian VK70XX Distek 2100, 5100, Evolution series ERWEKA DT800, DT700, DT720 Copley DT600, DT800 |
| Drivers for Spectrophotometers
| Pharma Test TIDAS L, T70, SA500 Agilent 8453, 8454 Agilent/Varian Cary50 J&M Tidas II (9-channel fiber optic) AnalytikJena 200/205/210/250 Beckman DU800 Kontron Uvikon XL Cecil 2000/3000/4000/7000/9000 series PerkinElmer LAMBDA 2/20/25/35/45 Shimadzu UV1700 PharmaSpec, UV1800 Tec5 MultiSpec Thermo Evolution 300 Zeiss MCS5XX, MCS6XX(2-channel fiber optic) |
| Drivers for Pumps | Pharma Test PT-SP6, PT-SP8 ISMATEC IPC/IPC-N Hanson AutoPlus MAXIMIZER, Vision G2 AutoPlus Hamilton Dynamix III Sotax CY-7-50, CP7 Varian Vk806 Watson Marlow 323Du Distek Evolution 4300 Solvias Micamix Dual Syringe |
| Drivers for Dilutor Autosampler & Fraction Collector Driver | Pharma Test DSR-M, PTFC Gilson 223 (Agilent G1811A) Hanson AutoPlus MultiFill, G2 AutoFill PerkinElmer AS90, AS93plus, S10 Sotax C613/C615 Varian Vk8000 Distek Evolution 4300 Valve Driver Hamilton MVP Rheodyne MX Series II Injector Drivers available on demand Agilent 8452A Beckman Du600 Distek 2230A PerkinElmer L265,365,465 |
DATA SHEET
PTWS 120D
DESCRIPTION
FEATURES
SPECIFICATION
SUPPLY SCOPE
DATA SHEET
DESCRIPTION
6-Station Tablet Dissolution Testing 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
SPECIFICATION
| Parameter | Specification |
| Display | 6″, 320×240 pixel color LCD, illuminated |
| Data Entry | Resistive touch screen, functional touch keys |
| Acoustic Signal | Programmable acoustic signal for operator information |
| Timer | Programmable sampling times, wake-up and sleeping mode, operation time information and timer count-down mode |
| Stirrer Position | 8 programmable stirrer immersion positions (paddle over disk, transdermal cylinder etc.) |
| Testing Method Programming | Unlimited number of different test descriptions can be stored on SD card |
| User Access Control | Multiple level access control, CFR compliant |
| OQ, PQ control | Programmable time periods to remind on QO or PQ testing |
| Printer | External PT-RP80 report printer using long-life printer paper |
| Number of Stirred Vessels | 6 (3 by 2 or 2 by 3 arrangement) |
| Standard Vessels | 1 liter USP/EP Borosilicate glass vessel, each individually coded |
| Vessel Covers | Ultra-low evaporation design (< 0.7% within 24h) |
| Stirring Speed Control | 25 – 250 RPM |
| Speed Accuracy | ±2% of set speed, typically < 1% |
| Stirrer Shaft Wobble | Better than 0.2 mm total run out |
| System Tools | MonoShaft™ stirrer design, USP/EP apparatus 1, 2, 5, 6 tool adapter, cream cell, transdermal patch tools, each tool and vessel individually coded |
| Heating System | Pump for water circulation and 1500W heater for fast heating up (230/240V units only) |
| Heater Range | 25 – 45°C |
| Heater Accuracy | ± 0.2°C inside the water bath |
| Heat Up Process | Energy saving, programmable “wake up” heater function and “sleep mode” |
| Water Circulation | Water circulated from external heating system through special diffuser inside the water bath |
| Vibration Elimination | External heating system, spring loaded pump assembly |
| Calibration | Built-in calibration procedures for speed, temperature control, OQ/PQ interval programmable including alarm indicator |
| Bench Space Requirement | 45 x 65 cm (2 by 4) or 65 x 45 cm (4 by 2) |
| Certification | All components certified to USP / EP requirements |
| CE / EMC Certification | All CE / EMC Certification provided |
| Validation | All IQ & OQ documents included |
SUPPLY SCOPE
Included in the Standard Scope of Supply
>Eco saving double walled vacuum molded water bath
>One set of stainless steel paddles
>One set of batch coded 1000ml Borosilicate glass vessels
>One set of depth adjustment balls
>One bottle of ALGEX water preservative
>Comprehensive documentation folder including:
>>User manual
>>DQ/QC instrument compliance test certificate
>>IQ documentation
>>OQ documentation
>>Instrument logbook
>>Compliance certificates for vessels and stirring tools
DATA SHEET
PTWS 120S
DESCRIPTION
FEATURES
SPECIFICATION
SUPPLY SCOPE
DATA SHEET
DESCRIPTION
USP/EP Tablet Dissolution Testing Instrument
The PTWS 120S is a 6-position, multiple 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 BP, DAB and Japanese Pharmacopeia section <15>. Its design for manual operation and ease of use.
FEATURES
>Automated temperature check and log at all sampling times
>Fully USP <711/724> and EP <2.9.3/4> compliant
>6 individually motorized stirred positions
>Centrally located motorized lift drive to raise and
>lower the drive head
>Individually coded Borosilicate vessels
>File up a nearly unlimited number of different test descriptions (methods)
>CAN Bus technology offering instrument suitability check prior to start of a test run
>Staggered start capability
>Vessel low evaporation sealing covers
>Removable water bath for easy cleaning
>Drainage tap to empty the bath
>Method management and CFR compliant user administration
>User Access control
>Optical and acoustic signals to inform about sampling intervals,
>Timer count down function
>Traffic Light optical information on display shows the instrument status by different colors (green = ready to use, yellow = preparing to use, red = error encountered)
>OQ, PQ interval warning with programmable interval
>USB port for remote control of the PTWS 120S
>RS-232 port to connect a serial PT-RP80 report printer, printing date/time, sampling time information, selected sampling position, used stirring tools, media temperature, operator name etc.
>I/O port for remote control of external instruments in automated applications, like DSR-M, Pumps and PTFC-2/8
Advantages
>6 stirring positions, individually electronically regulated high precision drive system for each one of the 6 stirrers.
>Grouping of stirrers, like 2 groups of 3, or 3 groups of 2 running at the same speed
>Modular design to minimize bench space requirements
>3-point individual vessel centering system
>Borosilicate glass vessels including extra low evaporation vessel covers
>Individual vessel batch code at the top of the vessel flange for easy identification
>Excellent access to all vessels
>Eco saving double walled vacuum molded water bath
>Motorized Drive Head lifting mechanism including head position programming facility
>Screen saver functionality and count-down timer offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>Wake up functionality to start heating at a pre-programmed time
>Ultra-fast heating system due to newly designed heat exchanger, saves up to 1/3rd of the heating up time compared to most other models
>MonoShaft™ system to avoid re-adjustment of immersion depth
>Staggered stirrer start feature for convenient manual sampling
>Water diffuser inside the vacuum moulded water bath for even temperature distribution and fast temperature equilibration
>Spring loaded pump assembly to eliminate vibration transfer
>Extraordinary safety features for pump and heating system, flow control, digital temperature control, thermo switch, thermo fuse
>Auto stirrer stop when drive lift is moved
>Excellent stirrer shaft verticality inside the vessels due to central position of lift columns, drive head assembly and rigid anodized aluminum framework
>Easy removal of the water bath from of the frame work for cleaning and maintenance work
>Energy saving double walled bath option, less heat transfer into the lab environment, less power consumption during instrument operation
>DQ/QC, IQ and OQ documents included free of charge
SPECIFICATION
| Parameter | Specification |
| Display | 6″, 320×240 pixel color LCD, illuminated |
| Data Entry | Resistive touch screen, functional touch keys |
| Acoustic Signal | Programmable acoustic signal for operator information |
| Timer | Programmable sampling times, wake-up and sleeping mode, operation time information and timer count-down mode |
| Stirrer Position | 8 programmable stirrer immersion positions (paddle over disk, transdermal cylinder etc.) |
| Testing Method Programming | Unlimited number of different test descriptions can be stored on SD card |
| User Access Control | Multiple level access control, CFR compliant |
| OQ, PQ control | Programmable time periods to remind on QO or PQ testing |
| Printer | External PT-RP80 report printer using long-life printer paper |
| Number of Stirred Vessels | 6 (3 by 2 or 2 by 3 arrangement) |
| Standard Vessels | 1 liter USP/EP Borosilicate glass vessel, each individually coded |
| Vessel Covers | Ultra-low evaporation design (< 0.7% within 24h) |
| Individual Speed Control | 25 – 250 RPM for each stirrer |
| Speed Accuracy | ±2% of set speed, typically < 1% |
| Stirrer Shaft Wobble | Better than 0.2 mm total run out |
| System Tools | MonoShaft™ stirrer design, USP/EP apparatus 1, 2, 5, 6 tool adapter, cream cell, transdermal patch tools, each tool and vessel individually coded |
| Heating System | Pump for water circulation and 1500W heater for fast heating up (230/240V units only) |
| Heater Range | 25 – 45°C |
| Heater Accuracy | ± 0.2°C inside the water bath |
| Heat Up Process | Energy saving, programmable “wake up” heater function and “sleep mode” |
| Water Circulation | Water circulated from external heating system through special diffuser inside the water bath |
| Vibration Elimination | External heating system, spring loaded pump assembly |
| Calibration | Built-in calibration procedures for speed, temperature control, OQ/PQ interval programmable including alarm indicator |
| Bench Space Requirement | 45 x 65 cm (2 by 4) or 65 x 45 cm (4 by 2) |
| Certification | All components certified to USP / EP requirements |
| CE / EMC Certification | All CE / EMC Certification provided |
| Validation | All IQ & OQ documents included |
SUPPLY SCOPE
Included in the Standard Scope of Supply
>Eco saving double walled vacuum molded water bath
>One set of stainless steel paddles
>One set of batch coded 1000ml Borosilicate glass vessels
>One set of depth adjustment balls
>One bottle of ALGEX water preservative
>Comprehensive documentation folder including:
>>User manual
>>DQ/QC instrument compliance test certificate
>>IQ documentation
>>OQ documentation
>>Instrument logbook
>>Compliance certificates for vessels and stirring tools
DATA SHEET
PTWS 820D
DESCRIPTION
FEATURES
SPECIFICATION
SUPPLY SCOPE
DATA SHEET
DESCRIPTION
USP/EP Tablet Dissolution Testing Instrument
The PTWS 820D is an 8-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>.
FEATURES
>Automated temperature check and log at all sampling times
>Fully USP <711/724> and EP <2.9.3/4> compliant
>8 stirred positions in a 4 + 4 arrangement
>Centrally located motorized lift drive to raise and lower the drive head
>Individually coded Borosilicate vessels
>File up a nearly unlimited number of different test descriptions (methods)
>Instrument suitability check prior to start of a test run
>Staggered start capability
>Vessel low evaporation sealing covers
>Removable water bath for easy cleaning
>Drainage tap to empty the bath
>Method management and user administration with access control
>Optical and acoustic signals to inform about sampling intervals, timer count down function
>Traffic light optical information on display shows the instrument status by different colors (green = ready to use, yellow = preparing to use, red = error encountered)
>OQ, PQ interval warning with programmable interval
>Interfaces: USB port for remote control of the PTWS 820D, RS-232 port to connect a serial PT-RP80 report printer, printing date/time, sampling time information, selected sampling position, used stirring tools, media temperature, operator name etc., I/O port for remote control of external instruments in automated applications, like DSR-M, Pumps and PTFC-2/8
Advantages
>Modular design to minimize bench space requirements
>3-point individual vessel centering system
>Excellent access to all vessels
>Eco saving double walled vacuum molded water bath
>Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>Wake up functionality to start heating at a pre-programmed time
>Ultra-fast heating system due to newly designed heat exchanger
>MonoShaft™ system to avoid re-adjustment of immersion depth
>Staggered stirrer start feature for convenient manual sampling
>Water diffuser for even temperature distribution
>Spring loaded pump assembly to eliminate vibration transfer
>Extraordinary safety features for pump and heating system, flow control, digital temperature control, Thermo switch, Thermo fuse
>Auto stirrer stop when instrument head is moved
>Excellent stirrer shaft verticality inside the vessels due to central position of lift columns and drive head assembly
>Easy removal of the water bath from of the frame work for cleaning and maintenance work
>DQ/QC, IQ and OQ documents included free of charge
SPECIFICATION
| Parameter | Specification |
| Display | 6”, 320×240 pixel color LCD, illuminated |
| Data Entry | Resistive touch screen |
| Acoustic Signal | Acoustic signal for operator information at programmable intervals |
| Timer | Programmable sampling times, wake-up and sleeping mode, operation time information and timer count-down mode |
| Stirrer Position | 8 programmable stirrer immersion positions (paddle over disk, transdermal cylinder etc.) |
| Testing Method Descriptions | Unlimited number of different test descriptions can be stored on SD card |
| User Access Control | Multiple level access control |
| OQ, PQ control | Programmable time periods to remind on QO or PQ testing |
| Printer | External PT-RP80 report printer |
| Number of Stirred Vessels | 8 (4 by 2 or 2 by 4 arrangement) |
| Standard Vessels | 1 liter USP/EP Borosilicate glass vessel, each individually coded |
| Speed Control | 25 – 250 RPM |
| Speed Accuracy | ±2% of set speed, typically < 1% |
| Stirrer Shaft Wobble | Better than 0.2 mm total run out |
| System Tools | MonoShaft™ stirrer design, USP/EP apparatus 1, 2, 5, 6 tool adapter, cream cell, transdermal patch tools, each tool and vessel individually coded |
| Heating System | Pump for water circulation and 1400W heater for fast heating up |
| Heater Range | 25 – 45°C |
| Heater Accuracy | ± 0.2°C inside the water bath |
| Heat Up Process | Energy saving, programmable “wake up” heater function and “sleep mode” |
| Water Circulation | Water circulated from external heating system through special diffuser inside the water bath |
| Vibration Elimination | External heating system, spring loaded pump assembly |
| Calibration | Built-in calibration procedures for speed, temperature control, OQ/PQ interval programmable including alarm indicator |
| Bench Space Requirement | 45 x 75 cm (2 by 4) or 75 x 45 cm (4 by 2) |
| Instrument Dimensions | Approx. 75 x 45 x 75cm (width x depth x height) |
| Packaging Dimensions | Approx. 120 x 80 x 110cm (width x depth x height) |
| Net / Gross Weight | 76 / 131kg |
| Certification | All components certified to USP / EP requirements |
| CE / EMC Certification | All CE / EMC Certification provided |
SUPPLY SCOPE
Included in the Standard Scope of Supply
>Eco saving double walled vacuum molded water bath
>One set of stainless steel paddles
>One set of 1000ml Borosilicate glass vessels
>One set of depth adjustment balls
>One bottle of ALGEX water preservative
>Comprehensive documentation folder including:
>>User manual
>>DQ/QC instrument compliance test certificate
>>IQ documentation
>>OQ documentation
>>Instrument logbook
>>Compliance certificates for vessels and stirring tools
DATA SHEET
PTWS 620
DESCRIPTION
FEATURES
SPECIFICATION
SUPPLY SCOPE
DATA SHEET
DESCRIPTION
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.
FEATURES
>Automated temperature check and log at all sampling times
>Fully USP <711/724> and EP <2.9.3/4> compliant
>8 stirred positions in a 6 + 2 arrangement
>Rigid motorized lift drive to raise and lower the head
>Individually coded Borosilicate vessels
>File up a nearly unlimited number of different test descriptions (methods)
>Instrument suitability check prior to start of a test run
>Staggered start capability
>Vessel low evaporation sealing covers
>Drainage tap to empty the bath
>CFR compliant method management and user administration with access control
>Built-in thermo printer to print a test-log at the end of a run
>Optical and acoustic signals to inform about sampling intervals, timer count down function
>Status bar with traffic light information on display shows the instrument status by different colors (green = ready to use, yellow = preparing to use, red = error encountered)
>OQ, PQ interval warning with programmable interval
>Interfaces: USB port for remote control of the PTWS 620, RS-232 port to connect serial devices, I/O port for remote control of external instruments in automated applications, like DSR-M, pumps and PTFC-2/8
>Calibration menu for stirrer speed, bath temperature
Advantages
>6 front line vessels for easy access in manual operation and optimal visibility
>Rigid aluminum water bath cover
>Individual 3-point vessel centering
>Excellent access to all vessels
>Staggered start feature for convenient manual sampling
>Screen saver functionality offers most important information at a glance (stirrer speed, bath temperature, time to next sampling interval, elapsed time, media temperature etc.)
>Wake up functionality to start heating at a pre-programmed time
>Programmable infinity test
>MonoShaft™ system to avoid re-adjustment of immersion depth
>Ultra-fast heating system with excellent temperature stability due to newly designed heat exchanger
>Water diffuser for even temperature distribution
>Vibration absorber to avoid vibration transfer into the USP/EP vessels
>Spring loaded pump assembly to eliminate vibration transfer to the frame work
>Extraordinary safety features for pump and heating system, flow control, digital temperature control, water level sensor, thermo switch, thermo fuse
>DQ/QC, IQ and OQ documents included free of charge
SPECIFICATION
| Parameter | Specification |
| Display | 6″- 320*240 pixel color LCD, illuminated |
| Data Entry | Resistive touch screen, alpha-numerical and functional keys |
| Acoustic Signal | Acoustic signal for operator information at programmable intervals |
| Timer | Programmable sampling times, wake-up and sleeping mode, operation time information and timer count-down mode |
| Stirrer Position | 8 freely programmable stirrer immersion positions (paddle over disk, transdermal cylinder etc.) |
| Testing Method Descriptions | Unlimited number of test descriptions can be stored on SD card |
| User Access Control | Multiple level access control |
| OQ, PQ control | Programmable time periods to remind about QO or PQ testing |
| Printer | Built-in thermo printer |
| Number of Stirred Vessels | 8 (6 + 2 arrangement) |
| Standard Vessels | 1 liter USP/EP Borosilicate glass vessel, each individually coded |
| Speed Control | 25 – 250 RPM |
| Speed Accuracy | ±2% of set speed, typically < 1% |
| Stirrer Shaft Wobble | Better than 0.2 mm total run out |
| System Tools | MonoShaft™ stirrer design, USP/EP apparatus 1, 2, 5, 6 tool adapter, cream cell, transdermal patch tools, tools & vessels individually coded |
| Heating System | Pump for water circulation and 1400W heater for fast heating up |
| Heater Range | 25 – 45°C |
| Heater Accuracy | ± 0.2°C inside the water bath |
| Heat Up Process | Energy saving, programmable “wake up” function and “sleep mode” |
| Water Circulation | Water circulated from external heating system through special diffuser inside the water bath |
| Vibration Elimination | Water bath rests on vibration absorbers, spring loaded pump assembly |
| Calibration | Built-in calibration procedures for speed, temperature control, OQ/PQ interval programmable including alarm indicator |
| Bench Space Requirements | Approx. 112 x 58 cm |
| Packaging | Approx. 137 x 78 x 87 cm (W x D x H) |
| Weight | 75 kg net weight, 100 kg gross weight |
| Certification | All components certified to USP / EP requirements |
SUPPLY SCOPE
Included in the Standard Scope of Supply
>One set of stainless steel paddles
>One set of batch coded 1000ml Borosilicate glass vessels
>One set of depth adjustment balls
>One bottle of ALGEX water preservative
>Comprehensive documentation folder including:
>>User manual
>>DQ/QC instrument compliance test certificate
>>IQ documentation
>>OQ documentation
>>Instrument logbook
>>Compliance certificates for vessels and stirring tools
DATA SHEET
