Dissolution Tests are conducted to determine the drug release patterns, physiological availability and bioavailability of formulated drug products. It is also used as a quality control tool. The Koehler Dissolution Apparatus provides state-of-theart dissolution testing with advanced features, which supports USP 1, 2, 5 & 6. This product is designed on the basis ofspecifications recommended by international regulatory bodies and the future needs of the Pharmaceutical Industry.

• Advanced, Micro-Controller based
• User-friendly, complies with current USP, IP & EP specifications
• Splash waterproof keyboard: Alphanumeric polyester soft keys for keyboard
• Molded water bath with 6+2 (3+1 & 3+1) vessel configuration enables comparative studies
• Built-in immersion pump for uniform water circulation with audible, low water level alarm with indication on display for safety
• Mono shaft design with easy changeover between Apparatus I & II eliminates routine height validation as per USP
• Tablet dispenser-drops 6 dosage forms at a single instance (Optional)
• 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 an external RTD Temperature Sensor (PT100)
• The Dissolution Tester meets all requirements relating to validation, qualification and calibration
• Appropriate qualification documents (I.Q. / O.Q.) can be supplied with the instrument

Features of the Automatic and Plus Dissolution Apparatus include: 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.

Ability to perform the dissolution test using two buffers (Buffer changing) for enteric coating tablets. Recovery Test facility to study 100% Drug Dissolution. Special software program for calculating % Drug dissolve v/s Time using individual tablet weight.

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. 6 vessel temperature monitoring system automatically measures and records the temperature of individual vessel at specified sample points.

Peristaltic Pump - Automatic Option

• Pump with click-n-go Cassette design provides defined and repeatable occlusion conditions
• Fixed length pump tubing with stopper for sampling volume accuracy
• Volume calibration through software
• Tygon pump tubing for SLS Compatibility
• High repeatability on all Channels
• 12 actively driven stainless steel rollers

Piston Pump System - Plus

• Microprocessor controlled and ideal for sample withdrawal from 6, 7, or 8 channels
• Eases filtration of sample before collection by using 0.22 & 0.45 μm Luer tip Syringe filters (fulfils the regulation of USP and other Pharmacopeias)
• Inert ceramic rotor overcomes absorption issues
• High flow rates of 25 ml / min can be achieved with accuracy better than 1%
• Rinse function for reducing carryover issue

Filter Changer - Plus

• Microprocessor controlled and designed to filter 6, 7, or 8 sampling lines simultaneously
• Accessory for Inline Filtering of Sample before collection through Syringe Filters
• High Storage capacity – up to 96 filters at a time gives uninterrupted filtered sample collection for 16 Sampling Points
• Used in conjunction with the Piston Pump for filtration down to 0.22 & 0.45 μm
• Individual channel sensors ensure filters are in place
• If syringe filter is missing, automatic switch-over of valves to collect unfiltered sample, with an indication in the printout

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.

Protects Editing, Avoids invalid entries: User interactive software in dialogue mode for ease of operation with protection against invalid entries. Multilevel password protection for method editing (10 users)

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.

• 10 x 6 or 16 x 6 sets of samples can be collected. For more sampling interval, 24 x 6 collection trays are available.
• Option of 1.5ml & 2ml HPLC vials tray is available
• Over Head Design for electronic safety and fail safe operation
• Sensor to locate proper position of tray with alarm facility for collection of sample
• Wide mouth vial to minimize SLS spillover problem due to foaming characteristics
• Easy positioning with respect to vials or test tube tray for easy changeover

Display: 40 x 2 line back light liquid crystal display (LCD)

Water Bath: 17 L capacity with built-in water level sensor and front located drain tap for easy draining

Temperature Range: 30ºC to 40ºC

Temperature Resolution: 0.1ºC

Temperature Control Accuracy: ±0.1ºC

Temperature Sensor: Pt-100 (RTD)

Paddle/Basket Shaft Speed: Range 20 to 250 RPM ±1%

Dissolution Vessel: option for Polycarbonate / Glass vessels (clear, amber, peak vessels, 250, 150 & 100 ml dissolution vessels available)

Sampling Time Selectivity: Fixed/Programmable

Time Interval Selectivity: In steps of 1 minute

Maximum Number of Intervals: 30

Dissolution Process Time: 1 min. to 720 hours

Environmental Operating Conditions:

  Operation: Indoor

  Temperature: Ambient to 45ºC

  Humidity: 5 to 90% non-condensing.

Output:

  Printer: Compatible for deskjet, inject and dot matrix printer with parallel port

  RS232C: For PC Connectivity

  21 CFR Part 11 compliance software available

Automatic and Plus Arrangements:

  Sampling Volume Range: 0.5 - 25.5 ml

  Replenishing mode selectivity: User selectable

  Rinsing Functionality: Optional

  Syringe Filter Capability (Plus ONLY)

Standard Units

• SS Paddles
• Baskets (USP Apparatus -1) with Mono Shaft
• Glass Bowls
• 25mm Depth Balls
• Cannula for Manual Sampling with Syringe
• Special Tablet Dispensing Attachment for simultaneous dropping of tablets/capsules/pellets

Automatic Units

• Intelligent Sampling Manifold
• Sample Collector with 72 position tray and 15 mL bottles
• Teflon Carrier Tubing with Tubing Connectors
• 10 Micron Filters
• Validation Software
• Cleaning Software with Waste Tray and Beakers