Automatic Leak Test Apparatus with 21 CFR Part-11 Compliance
(Without Vacuum Desiccator)

Technical Specifications

• Vacuum Controller : Microcontroller Based
• Maximum Vacuum Level : Greater than 650 mmHg
• Vacuum Stability :
  ● Set Value Below 400 mmHg : ±10mmHg within 30 seconds
  ● Set Value Above 400 mmHg : ±5 mmHg within 30 seconds
• Vacuum Hold Time : Variable from 1 sec. to 99 min
• Vacuum Release Time : Variable from 1 sec. to 5 min
• Vacuum Initial Delay Time : Variable from 1 to 60 second to achieve 100 mmHg
  (Run will be aborted if 100 mmHg is not achieved in 60 seconds)
• Vacuum Release : Auto - after completion of Vacuum Hold Time
• Vacuum Measurement : Digital
• Vacuum Measurement Units : mmHg, bar, kPa, inHg, atm, psi, cmH2O, kg/cm2
• Number of Sample : 1 to 99
• Calibration : With NABL Certified Standard Digital Vacuum Gauge
• Method : 40 methods with View, Print & Delete facility.
• Pharmacopeia Complies : As per USP, IP, Ph. Eur.
• Material of Construction : Stainless Steel
• Display : 20 x 4 Line Alphanumeric Backlit LCD
• Keypad : Membrane waterproof polycarbonate soft touch keypad compliance to UL/ROHS
• Calibration Data Storage : Non-Volatile Memory which can store, print & view calibration date & time, company name, Username, set and actual reading of Vacuum, calibration done by, instrument serial number, instrument ID, model number etc.
• Analysis Data Storage : More than 1500 analysis data can be stored with company name, analysis date & time, record number, batch number / ID, sample name, username, assigned method number, numbers of samples, set vacuum, vacuum hold time, vacuum release time, vacuum calibration date, Instrument model number, serial number, instrument ID etc. Secondly, analysis data can print online.
• 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 have to 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%, 50Hz
• Dimensions:
  ● Net Dimension: 38 x 31 x 23 cm (L x W x H)
  ● Gross Dimension: 48 x 43 x 42 cm (L x W x H)
• Weight:
  ● Net Weight: 11 kg
  ● Gross Weight: 13 kg