Tap Density Test Apparatus
With 21 CFR Part-11 Compliance

Model : µTDCal100 | Make : ANALAB | HSN Code : 90318000

Supplied with Holder for 100 ml & 250 ml Cylinder, 100 ml & 250 ml Cylinder, Power Cord, ANALABsafe software, USB Interface Cable, Operational & Instruction Manual with SOP, Calibration Test Certificate (Without Traceability Document) and Warranty Card.

Technical Specification

• No. of Station : Two
• USP Compliance :
  1) USP1 (300 taps per min.)
  2) USP2 (250 taps per min.)
  3) USP3 (55 taps per min.)
• Stroke Height : 14mm ±2mm / 3mm ±0.2mm
• Stroke / Minute : 300 ±10, 250 ±10, 55 ±5
• No. of taps : 1-9999
• Rotating and tapping motion : Simultaneous
• Display of Strokes/min : Simultaneously - Set & Actual
• Cylinder Supports : 100ml and 250 ml
• Pharmacopeia Complies : As per USP, IP, Ph. Eur.
• Method : 41 analysis method with View, Print & Delete facility.
• Calculation of result : Bulk Density, Tapped density, Compressibility index and Haunser ratio
• Weight Transfer : Possible through RS-232 Port (From Balance to Instrument)
• Display : 20 x 4 Line Alphanumeric Backlit LCD
• Keypad : Membrane waterproof polycarbonate soft touch keypad compliance to UL/ROHS
• Analysis Data Storage : More than 1500 data can be store in non-Volatile Memory which can print & view analysis data with Batch No., username, sample name, Bath Number/ID Tap/minute, Tap Hight, Tap Count 1, Tap Count 2, Tap Count 3, Tap Count Final,Weight of Sample, Total Number of taps, Initial Volume(Vo), Final Volume (Vf), Tap Density, Bulk Density, Compressibility Index, & Hausner Ratio, instrument serial number, Instrument Make & Model & Signature etc. Secondly, analysis data can be print online without saving analysis data in Instrument.
• Searching of data : With record number, batch number, date, date range and by scrolling.
• Report Formation : As per GLP Compliance
• 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 : Centronics Parallel Port / Serial (RS-232 C) Port
• Printer : 40 / 80 Column Dot Matrix Printer (Printer to be 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 : 230 VAC ± 10%, 50 Hz