Does the system comply with 21 CFR PART 11?

Yes, it supports electronic signature and record capabilities to ensure compliance with 21 CFR PART 11.

What is the main material used for the pipes?

The main material used is 316L stainless steel.

Purified Water Generation System for Pharmaceutical Industry

Name: Purified Water Generation System for Pharmaceutical Industry
Brand: Shandong Eagle Pharma Machinery Co., Ltd.
SKU: 2146855332

Shandong, ChinaShandong Eagle Pharma Machinery Co., Ltd.

US$80,000.00

1 Piece

Product profile

Customization

Available

Certification

ISO9001

Salt Rejection Rate

Model NO.

1900

Application

Industry

Capacity

19000L

Applicable Industries

Pharmaceuticals Laboratories Hospitals

Does It Support Inspection

Yes

Does It Support Customization

Yes

Electrical Control System Brand

Siemens

Transport Package

Wooden Case

Specification

304

Trademark

WEMAC

Origin

Weifang Shandong

Production Capacity

1/30days

Key features

Modular Compact Design: Boasts a compact structure and aesthetically pleasing layout for effortless operation and maintenance.

Dual Softener System: Features dual softeners with automatic regeneration, ensuring 100% water supply capacity and full program control.

Variable Frequency Control: Utilizes VFD for pumps to ensure precise pressure management, energy savings, and reduced microbial growth.

Stainless Steel Craftsmanship: Pipes are stretch-bent to minimize welding, with gas-protected automatic welding and electrochemical polishing.

Comprehensive Verification: Includes endoscope photos, solder joint diagrams, pressure test reports, and passivation reports for quality assurance.

HMI+PLC Automation: Features full-automatic control with intuitive interface, diverse communication modes, and three authority levels.

Real-time Monitoring: Monitors conductivity, temperature, and flow with optional paperless or traditional recorders for data management.

GAMP 5 & 21 CFR Compliance: Supports electronic signature and record capabilities to meet GAMP 5 and 21 CFR PART 11 audit tracking standards.

Company profile

In-stock CapacityQuality AssuranceR&D CapabilitiesFull Customization

Shandong Eagle Pharma Machinery Co., Ltd.

Shandong, China

Business Type: Manufacturer/Factory, Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service AvailableAverage Response Time: ≤2.53h

AI-Powered supplier vetting

SummaryThe supplier is identified as a trading company with a broad technical, equipment, software, and engineering-related business scope. It demonstrates professional technical R&D positioning, 3D software design, ODM, OEM, and multiple customization options. Quality and service procedures are partly established, including inspection instructions, complaint handling, supplier assessment, and corrective-action records. However, the supplier has only one quality inspector, has exported for one year, lacks raw-material traceability labels and written quality records, and has no overseas warehouse or showroom. Innovation evidence is mixed because no new products were reported in the past year and no SDK is available. Financial information is present only as year references, without sufficient evidence to assess credibility.

Supplier typeThe supplier is explicitly classified as a Trading Company. Its stated scope covers technical services, technology development, equipment sales, software development, IoT services, industrial engineering design, and equipment repair, indicating a technically oriented trading and service business rather than a clearly documented manufacturer.

After-Sales capabilityThe supplier has documented and followed procedures for complaint handling, supplier service-capability assessment, and corrective/preventive actions, and it reports in-stock service capability. However, it lacks overseas warehouse and showroom capabilities, so the evidence supports structured service handling but not comprehensive overseas support.

R&D capabilityThe supplier reports professional technical R&D capability, 3D software design, ODM services, and OEM services for popular brands. Counterbalancing this, it reported no new products during the past year and has no available SDK, so the evidence supports design and development services but not strong recent product innovation.

Customization capabilityThe supplier explicitly provides customization from samples, full customization, and customization from customer designs. It also offers 3D software design and ODM services, providing clear evidence of broad customization capability.