Friability Test Apparatus - Double Drum (21 CFR Part-11 Compliance)

Supplied with Roche Drum – 02 Nos., Drum Holding Knob with rubber bush, Removable Tablet Collecting SS Tray – 02 Nos., Acrylic Tablet Collecting Holder for SS Tray – 02 Nos., Power Cord, ANALABsafe software, USB Interface Cable, Operational & Instruction Manual with SOP, Calibration Test Certificate (Without Traceability Document) and Warranty Card.

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Technical Specifications:

Speed                                       : Variable from 20 to 70 RPM

Accuracy                                     : +0.5 RPM

Timer                                        : Variable from 1 sec. to 9 hrs. 59 min 59 sec.

Counter                                     : 1 to 9999 revolutions

No. of drums                              : Two

Display                                      : 20 x 4 Line Alphanumeric Backlit LCD

Keypad                                      : Membrane waterproof polycarbonate soft touch keypad compliance to UL/ROHS

Pharmacopeia Complies                : As per USP, IP, Ph. Eur.

Method                                      : 40 analysis method for single friability test with View, Print & Delete facility

Weight Transfer                        : Possible through RS-232 Port (From Balance to Friability)

Date                                          : 12/24 Hours Format

Time                                         : Real time clock

Tablet Discharge                         : Automatic in the Sample tray from drum after completion of analysis.

10º tilt                                       : With Audio Visual Alert message

Calculation of result                     : Friability in %

Calibration and Validation              : RPM, count, time & tilt with date & time

Power failure detection                 : Un-interrupted tablet testing after power resume

Report Formation                        : As per GLP Compliance

Searching of data                        : with record number, batch number, Date and by scrolling

Report Formation                        : As per GLP Compliance

Analysis Data Storage                   : More than 1500 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, user name, pharmacopeia, assigned method number, RPM,

  tilt status, drum type, set counts, actual counts, initial weight, final weight, friability

  result, analysis done on, model number, left & right drum number, serial number,

  instrument ID etc. Secondly, data can print directly without saving test data in the

  instrument.

21 CFR Part-11 Compliance       : ● In-built with system

  ● 1 Admin and 7 users with different Login ID & Password.

  ● Audit trail can store more than 5000 lines in system itself.

  ● 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.

  ● Once Audit trail transfer to the PC or Printer, automatically system

     will delete Audit trail records and before final deleting, the system

     will give warning twice.

Printer Interface                          : Centronics Parallel Port / Serial (RS-232 C) Port

PC Interface                               : USB Type – B

Printer                                       : 40 / 80 Column Dot Matrix Printer (Printer have to procure optionally)

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 and is password protected.

Power Supply                              : 230VAC ± 10%, 50 Hz

ANALAB SCIENTIFIC INSTRUMENTS PVT. LTD

ANALAB SCIENTIFIC INSTRUMENTS PVT. LTD
Manufacturer
India

Primary focus area

Analytical Products & Services

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