TYPICAL SPECIFICATIONS [Link]-analytical.

com
Control Micro Controller
Method Storage Minimum 1000 methods with parameters

TABLET DISSOLUTION

BLUE SERIES
Software Compliance 21 CFR Part 11
Temperature Range 20˚C to 55˚C
Temperature Accuracy up to 45°C ±0.1°C & >45°C up to 55°C ±0.2°C
TEST APPARATUS (6+2)
Temperature Resolution 0.1˚C
Temperature Sensor
Evaporation Loss
DTS - Digital Temperature Sensor
1% (at 50 RPM / 37˚C / 1000mL / 24hrs)
DS 8000
Display 7’’ high resolution display with capacitive touch screen (Auto)
Paddle/Basket Shaft Stirring Speed 20 to 350 RPM (20 to 250±1, 251 to 350±2)
Sampling Time Selectivity
Time Interval Selectivity
Vessel Capacity
Fixed / programmable (Varying Intervals)
In steps of 1 Minute
1000 mL
SMART
Water Bath 17 litres capacity with built-in water level sensor / front loaded
drain tap for easy draining of the water bath
Maximum Number Of Intervals 50
Dissolution Process Time 1 min to 1200 hrs
Print Interface USB / WiFi Direct enabled Printer
Data Backup Interface USB / LAN Port
Electrical Power 110/220V AC - 50 Hz/60 Hz
Dimension (W*D*H) 71.5*60*70.5 cm
Weight 80 kg Approx
Dissolution Vessel Option Polycarbonate / Glass Vessel (Clear & Amber)

21 CFR
PART 11
FULLY
COMPLIANT

[Link] / For Enquiries: [Link]@[Link]

Labindia Analytical Instruments Pvt. Ltd.

REGIONAL OFFICES:
Delhi: Tel.: +91-11-4330 6001 / 10 Chennai: Tel.: +91-44-2434 7008 / 2432 0352 Kolkatta: Tel.: +91-33-2466 3362
BRANCH OFFICES:
Bangalore: Tel.: +91 80 4565 6200 Lucknow: Tel.: +91-522-2346 535 / 2346 496 Hyderabad: Tel.: 040 4444 3530
[Link]

Vadodara: Tel.: +91-265-2986 005 / 2986 006 Pune: Tel.: +91-20-2545 3386 Chandigarh: Tel.: +91-172-4090 001-07 / 4090 009
The new LABINDIA Dissolution Apparatus DS8000 provide great versatility and configurability . It fulfils all requirements relating to ASTM & FDA
FACTORY 1: Plot No. EL-72, Electronic Zone, TTC Industrial Area, Thane Belapur Road, Navi Mumbai - 400 [Link].: +91-22-6107 6666 Mechanical Calibration. The state-of -the-art Dissolution Testing with touch screen is elegant in design and user friendly with advanced features. The
FACTORY 2: Plot No. W-401, TTC, MIDC Industrial Area, Rabale, Thane-Belapur Road, Navi Mumbai 400 701. Tel.: +91-22-6107 6555 DS8000 is precision engineered for USP<711> dissolution for ease of use.
APPLICATION & TRAINING CENTRE: R-909, TTC Industrial Area, Thane Belapur Road, Rabale, Navi Mumbai - 400 701. Tel.: +91-22-6107 6555 Allows storage of up to 1000 product test r un parameters.
Diagnostic functionality and validation repor t of the system is reliable enough for QC applications and flexible for R&D use.
Striving to become the best individuals, we endeavour to foster the best team. Performing sensibly, we try to achieve the best
efficiency. Working innovatively, we seek to make the best products. Listening patiently, we excel to offer the best service. So, no
matter what you needs are, come to us, GET THE BEST
LABINDIA reserve the right to change specification without notice as part of its continuous programme of product development. [Link]
 REGULATORY COMPLIANCE ADDITIONAL FEATURES
• DS 8000 meets all requirements relating to validation, qualification • Built-in Validation software.
• Advanced, Micro-Controller based: and calibration. • Facility to RINSE the entire sampling path in between sampling time-
User-friendly, complies with current USP, BP, IP & EP specifications. • Appropriate qualification documents (I.Q. / O .Q.) can be supplied with point to eliminate contamination & car ryover
• Moulded water bath with 6+2 (3+1 & 3+1) vessel configuration enables comparative studies. the instrument. • Specially developed cleaning system to clean the entire sampling
• Mono shaft design with easy changeover between Apparatus I & II eliminates routine height validation as per USP. path after each run.
• Paddles, Baskets and Vessels are laser marked with serial numbers for traceability. • Facilities to per form the dissolution test using two buffers (Buffer
• Automatic Tablet dispenser - drops 6 dosage form at single instance.
PERISTALTIC PUMP
changing) to cater the application of enteric coating tablets.
• Low Evaporation Lids: • Imported Pump with click-n-go Cassette design provides defined
• Recovery Test facility to study 100% Dr ug Dissolution.
» The conical shape low evaporation recovery lids reduces media loss during long run. and repeatable occlusion conditions.
• Split & on-time inter val
» Integrated pre-centered lids; no manual removal or positioning of lids. This ensures automatic vessel centering and precise positioning • Fixed length pump tubing with stopper for sampling
of paddle/basket with shaft without any special tool as per pharmacopeia requirements. volume accuracy.
• State-of-the-art design: • Volume calibration through software. REPORTS
» Easy placement and locking of vessels, the Ease-align system allows the vessels to simply slide into the place (Bionet Locking). • Tygon pump tubing for SLS Compatibility with long life. Selectable Report Format, complying with GLP requirements.
Once placed, vessels do not float even when empty. • High repeatability on all Channels. RUN REPORT
» Facility to monitor Vessel temp., with an external RTD Temperature Sensor (DTS - Digital Temperature Sensor) • 12 actively driven stainless steel rollers. a) Report giving Run No., Set parameters and Actual parameters during
the dissolution process.
b) Diagnostic functionality repor t to ensure proper working of the system
SAMPLE COLLECTION c) Printout of each vessel temperature and paddle/basket speed at ever y
• 10 X 8 or 16 X 8 sets of samples can be collected. F or more sampling sampling interval for validation.
interval, 24 X 8 collection trays are available. d) Validation repor t for Temperature, RPM, Sample Volume and
• Option of 1.5ml & 2ml HPLC vial tray is available. Replenishing Volume.
External vibration
free flow • Sensor to locate proper position of tray with alar m facility for
Water Circulator. collection of sample 21 CFR Part 11 COMPLIANCE
• Wide mouth vial to minimise SLS spillover problem due to foaming • Audit Trail for all activities with search facility , repor t generation and
characteristics printing
• Easy positioning with respect to vials or test tube tray for easy • 200 User ID’s with alphanumeric entries of user name, password and
changeover role based privileges selection
• Multi-level roles with password protection
• User authentication is per formed for each and ever y operation done
by user
• Customizable PDF repor t file can be created through print
• USB Printing eliminates the need of serial por t to connect with
instrument.
The user can take printout on any local or network printer as well
• Electronic signature functionality
• Manual Archive and Data Backup facility available

• GLP Compliance:
» QWERTY Keyboard for 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 1000 methods with parameters.
» Validation Software to validate RPM, Temperature, sampling volume & replenish volume.
• Protects Editing, Avoids invalid entries:
» User interactive software for ease of operation with protection against invalid entries.
» Multilevel password protection for method editing.
INTELLIGENT SAMPLING SYSTEM
• Ease in operation:
• Automated sampling as per USP Specifications. Sampling tubes are
» Dissolution RUN can be started with last run parameters.
lowered in the media only at the time of sampling and withdrawn
» Facility to view Set Parameters during RUN. immediately after sampling, thus no par t of the assembly contributes
» Auto Start facility to continue the dissolution analysis in case of short power interruption (especially useful for long duration analysis motion, agitation or vibration.
of sustained release tablets).
• Sampling tubes are accurately moved to the USP sampling position
» Reports can be obtained even after Resetting / Power off / Power failure conditions. i.e. a zone mid way between the sur face of media and the top of
» Error indication helps user to trace the problem. paddle/basket parameters, not less than 1 cm from the vessels wall
• Alarms and Indications: as selected in the method.
Audible indication for ready state of instrument. • 6 vessels temperature monitoring system automatically measures and
• Wake-up Alarm: records the temperature of individual vessel at specified sample points.
This unique feature automatically turns the bath heater ON at a predetermined time.