Packaging sealing tester

NegotiableUpdate on 01/30

Model

Nature of the Manufacturer: Producers

Product Category

Place of Origin

Online Consult

Overview

The packaging sealing tester $n is a device developed based on the ASTM F2338 testing standard approved by the US FDA, and has added pressure attenuation testing function on this basis, expanding the detection capability of the device. Suitable for rigid packaging containers or flexible packaging in the pharmaceutical industry, with easy operation, fast testing speed, repeatable test results, high sensitivity, non-destructive testing process on packaging, and no need for sample preparation. It can be used for research and development, QC quality control, or production workshop use.

Product Details

Packaging sealing tester

Dual system of vacuum attenuation and pressure attenuation

Model: MC Duo (VP)

Product Introduction

MC Duo (VP) is suitable for rigid packaging containers or flexible packaging in the pharmaceutical industry, with easy operation, fast testing speed, repeatable test results, high sensitivity, non-destructive testing process, and no need for sample preparation. It can be used in research and development, QC quality control, or production workshops. This device can replace traditional dyeing water bath and bubble methods.

MC Duo (VP) is a device developed based on the ASTM F2338 testing standard approved by the US FDA, and has added pressure attenuation testing functionality to expand its detection capabilities.

MC Duo (VP) is assembled with high-precision sensors to ensure fast testing speed, high testing accuracy, and reproducible test results.

Product Features:

The optimal detection sensitivity can reach 1-2 microns

Fast testing speed and wide applicability, suitable for products such as powder injection, freeze-drying, and water injection, suitable for rigid packaging containers or flexible packaging

Compliant with FDA, EU, China CDE regulations, and ASTM testing standards

Compliant with FDA 21 CFR part 11 requirements, with access control, audit trail, and electronic signature capabilities

Integrated design of vacuum attenuation and pressure attenuation

Quick switching between vacuum decay and pressure decay, easy to operate

Technical Specifications:

System or principle: Dual system of vacuum attenuation and pressure attenuation

Dual sensors

The optimal sensitivity equipment can reach 1-2 microns, and the sample sensitivity is related to specific packaging and products.

Packaging types include rigid packaging containers or flexible packaging in the pharmaceutical industry.

Product powder, freeze-dried or liquid

Application research and development, QC quality control, or offline sampling in production workshops

Compliant with FDA, EU, and China CDE regulations, ASTM F2338 testing standard, and FDA 21 CFR part 11 requirements

The data integrity meets the requirements of FDA 21 CFR part 11, with access control, audit trail, electronic signature, and database management functions

Parameters and data are stored in a database with a large storage capacity

Test results Pass/mail and differential pressure values

Differential pressure value resolution 0.1Pa

Vacuum or pressure source: external dry vacuum pump; Pressure source: external air compressor

Validation Package IQ/OQ/PQ and Methodology Development Validation Package

Verify micro flow meters or standard leak holes

Power supply 100-240VAC, 50/60Hz

Packaging sealing tester