Does the device support wireless communication?

Yes, it supports wireless communication functions and can expand data communication and network interface requirements.

What is the warranty period for this equipment?

The product comes with a one-year warranty and includes free spare parts for after-sales service.

Filter Integrity Tester, Bubble Point Tester, Audit FDA/GMP

Name: Filter Integrity Tester, Bubble Point Tester, Audit FDA/GMP
Brand: Xiangyi Thermal Instrument Limited
SKU: 2073177995

Hunan, ChinaXiangyi Thermal Instrument Limited

US$5,300.00-5,961.00

1 Piece

Product profile

Customization

Available

After-sales Service

Free Spare Parts

Warranty

One Year

Model NO.

FIT-8.0

Voltage

100-240 VAC 50Hz

Power

120W

Operation Pressure

100-10000 Mbar (1.5-145psi) ;

How to Use

Online / Offline

Applicable Environment

Grade B or Above

Operating System

Linux System

Transport Package

Export Packing

Specification

10KG

Trademark

Xiangyi

Origin

China

Production Capacity

100 PCS/Month

Key features

FDA/GMP Compliance: Meets FDA 21 CFR Part 11 and GMP standards with electronic signatures and audit trails.

Extensive Test Functions: Supports Bubble Point, Diffusion Flow, Water Immersion, and Ultrafiltration Membrane tests.

Large Data Storage: Stores up to 300,000 records with 5-year audit trail retention and 1000 pre-stored programs.

Customizable Interfaces: External interfaces and industrial buses can be customized for automated control systems.

Robust Design: IP54 dustproof and splashproof rating with IP65 front protection for field use.

User Management: Supports 1000 user accounts with 4-level authority and password login security.

Versatile Connectivity: Features RS232, USB, and optional wireless communication for data export and network integration.

Company profile

Xiangyi Thermal Instrument Limited

Hunan, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service AvailableExport Year: 2010-05-05 CertifiedNearest Port: Shanghai PortAverage Response Time: ≤10.28h CertifiedTerms of Payment: LC, T/T

About Our Factory & Business Background

AddressNo. 175 Yunqi Rd, Xiangtan, Hunan, China

Plant Area8000 square meters

Number of Employees36

Registered Capital10,000,000 RMB

International Commercial Terms(Incoterms)FOB, CIF, CFR

Average Lead TimePeak Season Lead Time: one month Off Season Lead Time: one month

Our Production Capability & Technical Expertise

Main ProductsLab Equipment

Production MachinesCutting Machine, Drilling Machine, Drilling Machine, Slotting Machine, Milling Machine, Manual Assembly Line, CNC Machine

R&D Engineers5 people

Our Industry Experience & Global Business Record

Year of Establishment2005-04-06

Main MarketsNorth America, Europe, Southeast Asia/ Mideast, Domestic

Number of Foreign Trading Staff1

Overseas Agent/BranchNo

Product Q&A

Q:Does the device comply with FDA and GMP regulations?

Yes, it fully meets FDA 21 CFR Part 11 and GMP requirements with electronic signatures and comprehensive audit trails.

Q:What test functions does the instrument support?

It supports Manual Bubble Point, Basic Bubble Point, Extensive Bubble Point, Pressure Holding, Diffusion Flow, Water Immersion, and Ultrafiltration Membrane tests.

Q:Can the external interfaces be customized?

Yes, external interfaces and industrial buses can be customized according to customer requirements for automated control.

Q:What is the maximum number of user accounts supported?

The system supports up to 1000 user accounts with four levels of authority management.

Q:How long can the audit trail records be stored?

Audit trail records can be stored for at least 5 years and are exportable and irreversible.