Tablet Dissolution Tester DS 8000+ with Piston Pump & Automatic Filter Changer
Dissolution testing is considered one of the most important Quality control test performed on pharmaceutical dosage forms. The Labindia dissolution tester DS 8000 can be configured with a piston pump and automatic filter changer. Main concern of analysts is sample filtration process after collection of sample. Hence to overcome this the dissolution tester along with the pump and filter changer was developed by Labindia to ease the dissolution testing procedure.
Automatic filter changer FC 08 is controlled by the Dissolution tester for sample withdrawal from 6, 7 or 8 lines. Any standard 0.45 micron syringe filters with 25mm diameter can be used. Upto 96 filters can be stored for uninterrupted sample filtering for 16 sampling points. Used filters are automatically removed and replaced with new ones.
FC 08 is used in conjunction with high pressure piston pump PP 08 with filtration down to 0.2 micron syringe filters for UPLC analysis.
- Advanced, Micro-Controller based: User-friendly, complies with current USP, BP, IP & EP specifications.
- Splash waterproof keyboard: Alphanumeric polyester soft keys for keyboard.
- Moulded water bath with 6+2 (3+1 & 3+1) vessel configuration enables comparative studies.
- External vibration free Water Circulator: for uniform water circulation, with audible, low water level alarm, with indication on display for safety.
- Mono shaft design with automatic adjustment for 25 mm depth setting with easy changeover between Apparatus I & II eliminates routine height validation as per USP.
- Paddles, Baskets and Vessels are laser marked with serial numbers for traceability.
- Tablet dispenser - drops 6 dosage form at single instance.
- Low Evaporation Lids: The conical shape low evaporation recovery lids reduces media loss during long run.
- Integrated pre-centered lids; no manual removal or positioning of lids. This ensures automatic vessel centering and precise positioning of paddle/basket with shaft without any special tool as per pharmacopeia requirements.
- State-of-the-art design: Easy placement and locking of vessels, the Ease-align system allows the vessels to simply slide into the place (Bionet Locking). Once placed, vessels do not float even when empty.
- Facility to monitor Vessel temp., with DTS Technology (Digital Temperature Sensor)
- Piston Pump - PP 08 is Microprocessor controlled and is ideal for sample withdrawal from 6, 7, 8 channels
- The Piston Pump - PP 08 with inert ceramic rotor overcomes all absorption issues
- High flow rates of 25 ml / min can be achieved with accuracy better than ±5%
- Rinse function for reducing carryover issues
- Surfactant Media Compatibility
- Automatic Filter changer FC 08 is Microprocessor controlled and designed to filter 6, 7, or 8 sampling lines simultaneously.
- Accessory for Inline Filtering of Sample before collection through Syringe Filters
- FC 08 is used in conjunction with high pressure LABINDIA Piston Pump-PP 08 with filtration
- High Storage capacity – up to 96 filters at a time gives uninterrupted filtered sample collection for 16 Sampling Points.
- Individual channel Sensors to ensure filters are in place.
- Incase the syringe filter is missing, automatic switch-over of valves to collect unfiltered sample, with an indication in the printout
- DS 8000+ with Piston Pump & Filter Changer meets all requirements relating to validation, qualification and calibration.
- Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument.
- Built-in Validation software.
- Facility to RINSE the entire sampling path in between sampling time-point to eliminate contamination & carryover
- Specially developed cleaning system to clean the entire sampling path after each run.
- Facilities to perform the dissolution test using two buffers (Buffer changing) to cater the application of enteric coating tablets.
- Recovery Test facility to study 100% Drug Dissolution.
- Split & on-time interval
- Automated sampling as per USP Specifications. Sampling tubes are lowered in the media only at the time of sampling and withdrawn immediately after sampling, thus no part of the assembly contributes motion, agitation or vibration.
- Sampling tubes are accurately moved to the USP sampling position i.e. a zone mid way between the sur face of media and the top of paddle/basket parameters, not less than 1 cm from the vessels wall as selected in the method.
- 6 vessels temperature monitoring system automatically measures and records the temperature of individual vessel at specified sample points.
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Control |
Micro controller based (Advanced version of microprocessor). |
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Display |
40 x 2 line back lighted liquid crystal display (LCD) |
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Keyboard |
Alphanumeric splash waterproof polyester soft keys. |
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Method Storage |
15 programs with parameters. |
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Data Storage |
Available with Non-Volatile memory. |
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Water Bath |
17 litres capacity with built-in water level sensor / Front located drain tap for easy draining of the water bath. |
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Bath Circulation |
External vibration free water circulator |
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Temperature Range |
20°C to 55°C |
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Temperature Resolution |
0.1ºC |
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Temperature Control Accuracy |
up to 45°C ±0.1°C & >45°C up to 55°C ±0.2°C |
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Temperature Sensor |
DTS - Digital Temperature Sensor |
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Evaporation Loss |
1% (at 50 RPM / 37˚C / 1000mL / 24hrs) |
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Paddle/Basket Shaft Speed |
Range 20 to 350 RPM |
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RPM Speed Accuracy |
20 to 300 RPM ±0.5 RPM & Above 300 RPM ± 0.8 RPM |
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Dissolution Vessel |
option for Polycarbonate / Glass Vessels (clear, amber, peak vessels, 250, 150 & 100 ml. dissolution vessels available) |
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Sampling Time Selectivity |
Fixed/Programmable (varying intervals) |
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Time Interval Selectivity |
In steps of 1 minute |
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Sampling Volume Range |
0.5 - 25.5 ml |
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Replenishing mode selectivity |
User selectable |
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Rinsing Functionality |
Optional |
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Maximum Number of Intervals |
30 |
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Dissolution Process Time |
1 min. to 720 hours |
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Syringe Filter Compatibility |
MDI, WHATMAN, MILLIPORE & AXIVA (25 mm diameter) (Certified filters available from LABINDIA) |
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6 Channel Temperature Reader |
Built-In |
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Report Format |
a) GLP & Pharmacopeia compliant
b) Program parameter report |
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Output |
a) Printer: Compatible for deskjet, inject and dot matrix printer
b) RS232C: For PC Connectivity
c) 21 CFR Part 11 compliance software available (Optional) |
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Power |
110 / 220 V AC - 50 Hz / 60 Hz |
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Environmental Operating Conditions |
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<!--[if !supportLists]--> b) Temperature: Ambient to 45ºC.
<!--[if !supportLists]--> c) Humidity: 5 to 90% non-condensing. |
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Dimensions |
71.5 x 60 x 70.5cms (W x D x H) |
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Weight |
80 kgs. approx. (Basic Dissolution System) |
LABINDIA reserve the right to change specification without notice as part of its continuous product development.
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GLP Compliance:
- Alphanumeric entries of Sample Name, Sample Number and Identification Number for authentication.
- Built-in Real Time Clock (RTC) for date and time on display and on printout.
- Daily Auto Incremented Run Number and factory entered CUSTOMER NAME with Instrument Serial Number on report printouts make the system foolproof.
- Non-Volatile memory storage of 15 methods with parameters.
- Validation Software to validate RPM, Temperature, sampling volume & replenish volume.
- Protects Editing, Avoids invalid entries: Two tier password protection - Admin and User
- Ease in operation: Dissolution RUN can be started with last run parameters.
- Facility to view Set Parameters during RUN.
- Auto Start facility to continue the dissolution analysis in case of short power interruption (especially useful for long duration analysis of sustained release tablets).
- Reports can be obtained even after Resetting / Power off / Power failure conditions.
- Error indication helps user to trace the problem.
- Alarms and Indications: Audible indication for ready state of instrument.
- Wake-up Alarm: This unique feature automatically turns the bath heater ON at a predetermined time.