PHARMA TEST – PTBA 211E

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Hãng sản xuất: PHARMA TEST

Model: PTBA 211E

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Features

Dual force mode instrument with linear speed increase and linear force increase modes
Multiple point validation procedure built-in
Programmable print-out of force increase curve

Advantages

Breakpoint testing of empty ampoules in compliance with the DIN EN ISO <9187-1/2:2010>
Force standard setting: linear speed increase 10mm/min. (adjustable)
Automatic re-start facility to speed up the testing sequence
Entry of time and date
Enter a 12 digit batch number
Documentation of all results using a separate PCL5 or dot-matrix printer
Programmable print-out of force increase curve
Data transfer via RS-232 interface
Validation and calibration program for the measurement station
Dual point adjustment of the load cell for the hardness test station
Multiple point validation (calibration)

Technical Specifications

Parameter	Specification
Display	LED Display showing number of tests and breakpoint result
Data Entry	Numerical and Functional keys
Standard Force Range	5.0 to approximately 300N (optional 500N)
Accuracy	< 1N
Resolution	0.074N (300N model) – 0.1482N (500N model)
Force Settings	Linear speed or linear force increase (standard setting: linear speed 10mm/Min)
Selectable Range	4.0 – 200 Millimeter/Minute or 5.0 – 200 N/Second
Accuracy	< 2% force or < 0.1% speed
Printer	Parallel Interface to connect Dot-Matrix or PCL 5 Printer
Interface	RS232 COM port
Calibrations	Multiple point for load cell precision using certified weights (PT-CAL15/30 and PT-CAL 50)
Calibration Guidance	Built-in calibration procedures the digital load cell
Adjustments	Two point adjustment – zero and 10kg
Force Detection Reproducibility	PT-MT3 Magnetic Tablet and suitable support
Instrument Housing	Stainless Steel (312) to meet GLP requirements
Bench Space Requirement	L 30cm x W 30cm x H 48cm (without external printer )
Certification	All components certified to DIN EN ISO requirements
CE / EMC Certification	All CE / EMC Certification provided
Validation	All IQ & OQ documents included

PTBA 211E

Ampoule Breakpoint Tester

The PTBA 211E ampoule breakpoint tester is designed and manufactured in compliance to the DIN EN ISO <9187-1/2:2010> standard. According to this standard the break point of ampoules has to be tested to control the quality during production of empty ampoules and prior to the filling process.

Print-Out Results

The result is immediately displayed and printed to a connected laser printer (PCL5 capable) or a dot-matrix printer. Repeat this until your series has been tested, get a full print-out including each individual result, date, time, serial number of the instrument, batch number of the product tested, mean value and deviations of the test series.

Operating Principle

The testing jaw is moved by means of a stepper motor into the neck of the ampoule to be tested. The ampoule is placed onto a DIN/ISO compliant support. As soon as the jaw meets the ampoule the instrument increases the force in a linear speed mode until the sample breaks, the usual force rate is 10 mm/min. As soon as the ampoule is broken, the maximum force will be displayed and printed. The test jaw moves back to the home position ready for the next test. As the operator can enter an automatic re-start time, the next test will be performed immediately after a new sample has been placed onto the ampoule support.

A movable tray holds the ampoule support; a Plexiglas (Perspex) screen protects the operator. A built-in lamp illuminates the handling area to ease the correct positioning of the ampoule at the support. Exchangeable ampoule supports allow the test of all kinds of ampoules from 1-30ml.