What is the operating pressure range?

The operation pressure range is 100-10000 Mbar (150psi).

Is the device suitable for cleanroom environments?

Yes, it features an IP54 dust and splash level (IP65 front) and is designed for cleanroom stability.

Lab Equipment Membrane Filter Integrity Tester, Compliance with CFR Part

Name: Lab Equipment Membrane Filter Integrity Tester, Compliance with CFR Part
Brand: Hangzhou Darlly Filtration Equipment Co., Ltd.
SKU: 2193736415

Zhejiang, ChinaHangzhou Darlly Filtration Equipment Co., Ltd.

US$9,500.00-15,000.00

1 Piece

Sample price:US$10000.00/piece.Request sample

Product profile

Customization

Available

Application

Pharmaceutical Industry, Medicine

Cleaning Method

Manual Cleaning

Model NO.

DL501

Operating Pressure

150psi

Trademark

Darlly

Origin

Hangzhou

HS Code

8421999090

Key features

FDA 21 CFR Part 11 Compliance: Meets FDA 21 CFR Part 11 and GMP guidelines for electronic records and calibration.

Comprehensive Test Methods: Supports BP, DF, WI, Pressure Holding, and Ultrafiltration membrane integrity tests.

High-Precision Sensors: Advanced sensors and algorithms extend gas path to 100m for accurate upstream volume tests.

Robust Data Integrity: Includes audit trail, electronic signatures, and 5-year irreversible record storage.

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

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

Built-in Thermal Printer: Avoids particle/ink contamination and keeps handwriting clear for over 10 years.

Versatile Filter Support: Tests up to 12-core 20-inch filter cartridges, including needle and capsule filters.

Company profile

Hangzhou Darlly Filtration Equipment Co., Ltd.

Zhejiang, China

Business Type: Manufacturer/FactoryExport Year: 2005-01-01Nearest Port: Ningbo, ShanghaiAverage Response Time: ≤4.79hTerms of Payment: LC, T/TInternational Commercial Terms(Incoterms): FOB, EXW, CIF, DDP

AI-Powered supplier vetting

SummaryHANGZHOU DARLLY FILTRATION EQUIPMENT CO., LTD. demonstrates broad customization, R&D, ODM, OEM, inventory, and export capabilities. It reports 19 years of export experience, self-operated import/export rights, structured finished-product inspection, and documented complaint-handling and corrective-action procedures. The supplier has valid contracts with associated subcontractors and 16 qualified service suppliers. However, no overseas warehouse, showroom, agents, branches, or overseas service countries are reported. Financial credibility cannot be assessed because the provided financial entries only identify years, without financial performance or monetary data. Certification holdings, production scale, and detailed customer outcomes are also not evidenced. Customer-case evidence is limited to one named buyer and participation in one offline trade show.

Supplier typeThe supplier is presented as an export-oriented manufacturer/service provider with self-operated import/export rights, 19 years of export experience, inventory capacity, and valid contracts with associated subcontractors. Shipment records identify filtration cartridge products and one associated buyer, while no overseas branches, agents, warehouses, or showrooms are reported.

After-Sales capabilityThe supplier has documented and followed procedures for customer complaints and corrective/preventive actions, with written service-assessment procedures and a partially provided approved-supplier list. However, it reports no overseas agents, branches, or overseas service countries, limiting evidence of local international after-sales coverage.

R&D capabilityThe supplier reports new products within the past year, ODM service, broad design customization, an available SDK, and ERP-based digital management covering production, procurement, quality control, and logistics. These entries support active R&D and digital-process capability, although no specific innovation outputs or technical performance metrics are provided.

Production capacityProduction-related evidence includes uniformly followed finished-product inspection instructions, inventory capacity, valid contracts with each associated subcontractor, one-month lead times in both peak and off-season periods, and 16 qualified suppliers. The slices do not provide production volume, facility scale, or equipment details, but the documented operating controls support a positive capability assessment.

Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, full customization, minor customization, and flexible customization. It also reports R&D capability, new-product activity within the past year, and ODM service, directly supporting a broad customization offering.

Client casesEvidence includes participation in the German Filtration & Separation Exhibition and a shipment-related record naming DAX WATER TECH INDUSTRIES PRIVATE LIMITED as an associated buyer for two spun cartridge filter specifications. The slices do not provide multiple verified case studies, project outcomes, or customer testimonials, so the evidence is limited but positive.

Product Q&A

Q:Does the device comply with FDA regulations?

Yes, the DLE-501 meets FDA 21 CFR Part 11 requirements for electronic records and 21 CFR 820.72 for calibration.

Q:What test methods are supported?

It supports BP, DF, WI, Pressure Holding, and Ultrafiltration membrane integrity tests.

Q:Can the external interfaces be customized?

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

Q:What is the data storage capacity?

The instrument can store 300,000 sets of historical records and audit trails for at least 5 years.

Q:How many users can access the system?

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

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Lab Equipment Membrane Filter Integrity Tester, Compliance with CFR Part