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Beijing Niuyin Huaxin Technology Development Co., Ltd
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Beijing Niuyin Huaxin Technology Development Co., Ltd

  • E-mail

    2850659689@qq.com

  • Phone

    18600288605

  • Address

    2-501 Ziyu International, No. 2 Yinhe South Street, Shijingshan District, Beijing

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Xisen bottle safety and bottle sealing tester

NegotiableUpdate on 01/30
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Overview
Xisen bottle safety bottle sealing tester: The packaging sealing tester is suitable for testing the integrity of drug packaging sealing to prevent product contamination by moisture, oxygen, and microorganisms. Pharmaceutical products: bottled, bagged, boxed, ampoule, penicillin bottle, cartridge bottle, pre filled needle (PFS), (BFS), (FFS), etc; Spray cans: plunger spray cans; Lined bag spray cans; Energy set spray cans; Elastic tube spray can;
Product Details
Xisen bottle safety and bottle sealing tester


1、 Instrument features:

◎ Complies with USP<1207>、 ASTM F2338 standard and FDA standard

Semi automatic detection, suitable for small batch and multi variety testing;

Non destructive non-destructive testing, high precision, repeatability, and sensitivity;

Dual detection system: vacuum attenuation testing system, pressure attenuation testing system;

According to different testing modes, provide measured leakage rates and equivalent aperture sizes;

The detection result database is stored for easy quality management;

Flexible information display, operating status, and testing curves to meet different process requirements;

◎ Adopting vacuum pump and compressed air detection, with low cost of use

◎ Touch based human-machine interface, simple and fast operation: after setting/selecting the testing program, only manual insertion/removal of the testing sample is required;

2、 Advantages and functions of packaging sealing tester:

Adopting independently optimized Linux system;

Optimized testing calculations have shortened testing time, and different testing parameters can be set for different tested objects, and multiple predetermined plans can be established to facilitate customer use;

◎ Automatic leak rate testing throughout the process and conversion to equivalent aperture size

◎ Automatic leakage rate and equivalent aperture calibration function

◎ Equipped with standard leak holes (standard positive bottles with third-party certification)

Compliant with GMP and FDA CFR 21 Part 11, supports multi-level user access permission settings to ensure data integrity, has comprehensive audit tracking functions, and supports manual or electronic signatures;

Up to four poles of user management permissions, and each user's permissions can be determined by default or customized methods, more flexibly meeting the management needs of on-site production and laboratories;

◎ Split design, with the testing chamber located above the host, providing various testing chambers according to different product types;

The design of the testing chamber combines the positive and negative pressure systems organically through the coordination of software and hardware, which not only improves the testing accuracy but also ensures the reliability of the instrument;

We also provide users with supporting services related to sealing testing, including the production of positive bottles, annual calibration of standard leakage rates/holes, customization of new sample molds, and development and validation of sample methodological parameters.

◎ The testing chamber is customized according to customer needs to ensure that it matches the customer's product and can be tested quickly and sensitively

Optimize the instrument structure to achieve a dust-proof and splash proof level of IP54. Use quick connectors (Staubli connectors can be used) to avoid incorrect connections in the inlet and outlet pipelines and gas leakage;

◎ Support the data export function of USB drive, which can not only export the raw data of testing, but also export metadata and configuration data, so that the requirement of data integrity is reflected in this instrument;

◎ Can expand data communication and network interface functions according to customer requirements, and support wireless communication functions;

◎ Adopting a bilingual operation interface in both Chinese and English to facilitate the use of different users;

Optimized the intake control unit, significantly increasing the intake speed and stability;

IIIXisen bottle safety and bottle sealing testerSpecifications:

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

Minimum detectable aperture

1~2μm

display mode

10 inch color touch screen

power supply voltage

AC100V-240V,50/60Hz, Power ≤ 200W

audit trail

Store multiple event logs for ≥ 10 years, which can be queried based on time

Permission Management

Login with username and password, level 4 permissions, meeting FDA 21CFR PART 11 requirements, automatic screen lock, password unlock,

Print function

Built in micro printer

history

≥ 10 years of storage

data backup

Support exporting data from USB flash drive

signal output

(4-20) mA, RS485, 12V alarm output

interface

Ethernet, USB, RS485