Penetrability Tester

This equipment is used to measure the force required by a 21-gauge hypodermic needle to penetrate the rubber stoppers on glass vials.

Confirm to : USP 381

PackTest Product Video on Youtube

Description

Penetrability Tester
Variable Speed Model with Stepper Drive
Computer Controller Model with facility to capture test data on to the PC directly through the software and generate PDF test reports.
Digital Model with Backlit LCD Display for easy readability.
With Peak hold facility.
Motorised operation with Ball screw mechanism for extra smooth operation.
Not dependent on operator skill.
Variable Speed of Travel : 10-500 mm/min. (Menu based user-settable option)


Model: PT-10-DS-DX          Capacity:         10 Kg with least count of 1 gm.


Includes :

  • Syringe Holder (common fixture using standard syringe 2ml)           1 nos
  • Vial Holder (for each vial type of different diameter)                          3 nos
    • Extra Vial Holders can be purchased at additional cost.
  • Starter set of 100 needles (0.8mm / 21G)                                          1 set
    • Extra Set of needles can be purchased in pack of 100 pcs (or can be purchased from any medical consumable vendor).
  • Serial Port (9 Pin DB Connector)
  • RS-232 Data Cable
  • Standard Software for Win7 or higher. You have to take printout and store hardcopy of report. Hence 21CFR is not applicable.

Note : Software can be customized as per your requirement. Charges for the same can be quoted after receiving your detailed URS.

Excludes :

  1. Calibration Weight : 3 Kg (in any combination) Bullion weight to be supplied by you.
  2. Desktop PC (with Serial Port)
  3. Laser / Inkjet Printer 

Note : The Software is not fully 21-CFR-11 compliant.


Existing Security Features of the current software version:

  • 8 User Logins + 1 Admin/Supervisor Login.
  • Only admin can add/delete users and change passwords.
  • All users have individual Full Name, Username and Password.
  • Full Name of the user (Digital Signature) is pasted on the Test Report automatically.
  • Test Data is compiled as a PDF Test Report and no raw data is saved on the PC.
  • Calibration also done via software and PDF Test Report Generated.
  • Audit Trail Report with basic details.
  • Audit Trail also captures “Aborted Tests”

Utilities Required :

  • Power : 230/110 Volts A.C., 50/60 Hz. Clean power.
  • Calibration weights : 3 Kg (5 + 0.5 + 1 + 1 Kg)
  • Desktop PC or Laptop PC
    • Processor Type :   Intel Core I3 or better. (Preferably Core I5 or Higher)
    • Memory :              4 GB RAM or better
    • Space :                  50 GB free HDD space           (minimum)
    • Monitor :               17” or larger Color Monitor with 1280 x 1024 resolution or better
    • Operating System: Windows 7 Home Premium or higher (with latest updates & patches)
    • Supporting Software :       Adobe Acrobat Reader and Microsoft Dot Net Framework           (Latest Version)
    • Printer :                 Laser or Inkjet Printer.           (No Dot-matrix support)

IQOQ / Validation Documentation Set available for Pharmaceutical Companies

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