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Ampoule Leak Tester

Ampoule Leak Tester

Ampoule Leak Tester It is suitable for sealing integrity testing of pharmaceutical packaging to prevent moisture, oxygen, and microorganisms from contaminating products. Medicines: bottled, bagged, boxed, ampoules, vials, cartridges, prefilled needles (PFS), (BFS), (FFS), etc.
Spray cans: plunger spray cans; bag-lined spray cans; "energy jacket" spray cans; flexible tube spray cans.

Product Introduction

Ampoule Leak Tester

 

 

Parameters:

Differential pressure sensor

±2kpa, error≤0.5%F.S.

Differential pressure resolution

0.1pa

Test pressure sensor

Error≤±1%F.S.

Test pressure range

-0.1~0.2Mpa /-0.1~0.7MPa/-0.1~1.0Mpa(optional)

Minimum detectable aperture

2μm ( for IV bag minimum 5μm)

Display method

10-inch touch color touch screen

Voltage

AC100V-240V, 50/60Hz, power ≤200W

Weight

Host: about 30kg

Audit trail

>=5 years of storage Multiple event logs, which can be queried according to time

Authority management

Login with username and password, level 4 authority, meet FDA 21CFR PART 11 requirements

Print function

Built in printer

History record

>=300000 storage

Data backup

Support U disk to export data

Interface

Ethernet USB RS485(optional)

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Different chamber and inside part for different products: storage tank , 25ml vial ,500ml vial 

 

 

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Ampoule Leak Tester Main Features:

● Comply with USP <1207>, ASTM F2338 standards and FDA standards.

● Semi-automatic detection, suitable for small batch and multi-variety testing.

● Non-destructive non-destructive testing, high accuracy, repeatability, sensitivity.

● The instrument is used for vacuum pressure ,pressure decay difference detection.

● The leak rate can be automatically converted into defect aperture μm.

● Database storage of test results for easy quality management.

● Database storage of test results for easy quality management.

● Touch-type man-machine interface, simple and quick operation: after setting/selecting the test program, only need to manually put in/take out the test sample.

 

Ampoule Leak Tester Advantage function:

● Adpot automous optimization Linux system

● Automatically test the flow rate and change the aperture size during the whole process.

● Automatic leak flow calibration function.

● Equipped with standard leaks (standard leak bottles, with third-party certification).

● Four-level user authority management meets FDA 21CFR PART 11 requirements.

● With audit trail function.

● Split design, the test chamber is located above the host, and various test chambers can be provided according to different product types.

● We also provide users with supporting services related to tightness testing, including positive bottle(mould) production, standard leak rate/annual leak verification, new sample mold customization, sample methodological parameter development and verification, etc.

● The test cavity is customized according to customer needs to ensure that the test cavity is fully matched with the customer's product, and rapid and sensitive testing.

 

Ampoule Leak Tester  Application:

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Certificate

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Deliver,shipping and Package

 

Wooden case carton inside

After payment 6-8 weeks, by air,ship

 

 

Aftersale service

Three month replacement for free,one year warranty and long-life maintenance.

 

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