MLT-01 Micro Tester di perdite

MLT-01 Micro Tester di perdite
Micro Leak Testing Machine MLT-01

Il tester per microperdite MLT-01 utilizza una tecnologia avanzata di decadimento del vuoto per effettuare test di tenuta precisi e non distruttivi su varie forme di imballaggio, garantendo un'elevata accuratezza nel rilevare anche le microperdite.

Introduzione

ASTM F2338 Vacuum Decay Leak Tester

The MLT-01 Micro Leak Tester applies the vacuum decay method, a non-destructive technique ideal for identifying micro-leaks in rigid and flexible packaging. With dual-sensor technology and a highly sensitive detection system, the MLT-01 guarantees reliable results for industries focused on product protection and safety.

The MLT-01 Micro Leak Tester is designed to provide advanced leak detection using the vacuum decay method. This non-destructive, highly accurate testing technique ensures the integrity of various packaging types, from vials to infusion bags, by detecting leaks within the headspace or below the product fill line. Equipped with dual-sensor technology, it offers precision measurement for micro-leak detection, making it suitable for industries requiring stringent packaging validation.

The system’s automated functions, intuitive PLC controls, and HMI interface streamline testing processes, enabling reliable and repeatable results. Capable of customizing test parameters, the MLT-01 caters to a broad range of applications, ensuring package integrity and compliance with critical standards like ASTM F2338, YY-T 0681.18, and USP <1207.2>.

Plastic Ampoule Vacuum Decay Leak Test
Plastic Ampoule Vacuum Decay Leak Test
Syringe in Vacuum Decay Leak Test
Syringe in Vacuum Decay Leak Test

Applicazione

Il MLT-01 Micro Tester di perdite is primarily used to evaluate the packaging integrity of sealed containers that require sterility and product safety. It is ideally suited for applications requiring stringent leak detection.

  • Vials
  • Ampoules
  • Prefilled syringes
  • Infusion bottles and bags
  • Pharmaceutical and medical device packaging

By identifying micro-leaks that can’t be seen with the naked eye, the MLT-01 helps companies protect their products from contamination and ensure compliance with regulatory standards.

Metodo di prova

The MLT-01 employs the vacuum decay method, which detects leaks by measuring pressure loss in a vacuum-sealed chamber. The test process consists of several phases:

Processo di test:

Fill: The sample is secured in the test chamber, and negative pressure is applied.
Settle: The pressure is stabilized to allow for any stretching or flexing.
Test: Any increase in pressure during the vacuum decay phase indicates a leak.
Vent: The chamber returns to atmospheric pressure.
Pass/Fail: The system evaluates the pressure data to determine if the sample passes or fails based on predefined criteria.

This non-destructive testing method is highly sensitive, with the ability to detect leaks as small as 1-2 microns.

Vacuum Leak Rate Profiles and Test Stages
Vacuum Leak Rate Profiles and Test Stages

Caratteristiche tecniche principali

Absolute Pressure Range (0~300) kPa
Differential Pressure Range (-2~2) kPa
Sensitivity 1~2 μm
Balance/Test time 1~3600 s
Vacuum Time 1~3600 s
Set Flow Rate0-3 ml/min
Test SystemDual Sensor Technology / Dual Cycle Test
Test ChamberCustomized based on sample dimensions
Configurazione:
Standard: Main machine, vacuum pump, high-precision gas flowmeter, test chamber, 3 sets of positive and negative control
Opzionale: Software, camere di prova personalizzate

Caratteristiche tecniche

Dual-Sensor Technology

Offers highly precise pressure monitoring and leak detection.

Customizable Settings

Adjustable vacuum pressure, sensitivity, and test parameters to suit various applications.

Interfaccia facile da usare

HMI a colori da 7 pollici per facilitare il funzionamento e il monitoraggio dei dati.

Ampia gamma di applicazioni

Compatibile con diversi tipi di confezioni, da quelle rigide a quelle flessibili.

High-quality vacuum components per prestazioni stabili

Impostazioni di autorità multiple a livello di utente per soddisfare i requisiti GMP

Non-destructive Testing

Ensures the sample remains intact post-test.

Alta sensibilità

Capable of detecting micro-leaks down to 1-2 μm.

Advanced Reporting

Test result printing and data storage. Auditing and access level setting.

Advanced Reporting

Test result printing and data storage. Auditing and access level setting.

Software per PC (opzionale) per migliorare il monitoraggio e la gestione dei dati

Unità di pressione commutabili tra mbar e Pa per applicazioni versatili

Domande frequenti

Standard

Conformità agli standard globali per i test di tenuta

ASTM F2338: Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
YY/T 0681.18-2020: Test methods for sterile medical device package–Part 18: Nondestructive detection of leaks in packages by vacuum decay method
USP 1207.2〉: Package Integrity Leak Test Technologies

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Contatto

Indirizzo

No. 5577, Gongyebei Rd, Licheng Dist. 250109, Jinan, Shandong, Cina

marketing@celtec.cn
+86 185 6001 3985
08.00 - 18.00 (GMT+8)

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