Tablet Dis-integration Test Apparatus with 21 CFR Part-11 Compliance
(Independent Motor & Timer for Two Basket)

Technical Specification

• Stroke Length : 55mm ±2mm
• Number of Stroke Frequency Rate : 29–32 Cycles Per Min.
• Readable Temperature Range : 10.0°C to 50.0°C
• Temperature Control Range : 30.0°C to 40.0°C
• Temperature Accuracy : ±0.2°C
• Temperature Resolution : 0.1°C
• Programmable Timer : 1 sec. to 9 hrs.: 59 min.: 59 sec.
• Heating time to 37°C : Less than 20 min.
• Heating Technology : Bathless
• Heater Capacity : DC Heater-150 Watt
• Heating : Bathless heating results into fast heating and save water
• Temperature Sensor : PT-100
• Number of Beaker : Two – Capacity 1000 ml
• Number of Motor : Two
• Number of Timer : Two
• Number of Basket : Two (Six Test Tube Per Basket)
• Control of Basket : Independent Motor & Timer for Two Basket
• Display : 40 x 4 Line Alphanumeric Backlit LCD
• Loading of Basket : Magnetised for ease of cleaning
• Illumination : White Light for better visibility of dis-integration process
• Parking of Basket : Automatic after completion of test
• Keypad : Membrane waterproof polycarbonate soft touch keypad compliance to UL/ROHS
• Pharmacopeia Complies : As per USP, IP, Ph. Eur.
• Method : 40 analysis method with View, Print & Delete facility
• Date : 12/24 Hours Format
• Time : Real time clock
• Searching of data : With record number, batch number, Date and by scrolling
• Report Formation : As per GLP Compliance
• Analysis Data Storage : More than 750 data can be store in non-Volatile Memory which can print & view company name, print date and time, analysis date & time, record number, batch number / ID, sample name, username, pharmacopeia, assigned method number, analysis done on, model number, serial number, instrument ID, individual dis-integration time of each sample when you did visually detect the dis-integration of the tested sample by simply pushing the relevant character key (1-6), Basket Set & Actual Temperature, Media Used, etc. Secondly, data can print online without saving analysis data in the instrument.
• 21 CFR Part-11 Compliance :
  ● In-built with system for ease of operation without PC.
  ● 2 Admin, 10 Reviewers, 40 Users & 1 Manufacturer with individual Login ID & Passcode.
  ● Audit trail can store more than 5000 lines in instrument.
  ● Audit trail includes action taken, date & time, action taken by whom.
  ● Audit trail can be transfer to PC through ANALABsafe software and can print on 40 / 80 column dot matrix printer for record.
  ● Admins can set up operation permission of each Users & Reviewers.
  ● Strict Admins control to audit and monitor usage and access.
  ● Audit trail record can be printed with Date, Date Range and by individual User’s ID.
  ● Once Audit trail transfer to the PC or Printer, system will delete Audit trail records and before final deletion, the system will give warning twice.
  ● Data integrity with database capability to store Analysis Data, Calibration Data, Calibration and Analysis Method, Audit trail and Passcode in instrument.
  ● No direct access to data from outside the instrument, thereby creating a closed system.
  ● Audit traceability to ensure that the device and results are appropriately handled.
  ● Auto User’s logout after defined Logout time.
  ● Auto Users & Reviewers block when password is entered incorrectly 3 consecutive times
• Printer Interface : Serial (RS-232 C) Port
• Printer : 40 / 80 Column Dot Matrix Printer (Printer must procure optionally)
• PC Interface : USB Type - B
• PC Connectivity : By USB Interface Cable with Driver, ANALABsafe software to transfer Analysis data in GLP format, Calibration data and Audit trail from Instrument to PC in non-editable format (Cannot Delete)
• Power Supply : 230VAC ± 10%, 50 Hz
• Dimensions : 460 x 450 x 710 mm (L x W x H)
• Weight : 24.5 Kgs (Net) & 29.0 Kgs (Gross)