Can the control system comply with 21CFR PART11?

Yes, the PLC automatic control system can comply with 21CFR PART11 requirements.

What is the power supply requirement?

The power supply options are 220V, 380V, or 110V.

Where is the product manufactured?

The country of origin is China.

High-Quality GMP Compliant Purified Water System with CIP Technology

Name: High-Quality GMP Compliant Purified Water System with CIP Technology
Brand: Shandong Eagle Pharma Machinery Co., Ltd.
SKU: 2138871922

Shandong, ChinaShandong Eagle Pharma Machinery Co., Ltd.

US$40,000.00

1 Piece

Product profile

Customization

Available

Application

Chemical industry, Energy & Mining, Food & Beverage Factory, Pharmaceutical Industry

Capacity

1000 L/hr

Model NO.

Purified Water System

Certification

CE, FDA, GMP, ISO

Control System

Fully Automatic

Treatment Process

Filtration, Ozonation, Reverse Osmosis, Softening

Warranty of core components

One Year

Components

Ultrafiltration, Water Softening, Reverse Osmosis

Material

Stainless Steal 304/316L

Weight

Customized

Size

Customized

Country of Origin

China

Core Components

Gear

Transport Package

Wooden Case

Trademark

WEMAC

Origin

China

HS Code

84212199

Production Capacity

One Piece/Month

Key features

GMP & FDA Compliant: Certified for Pharmaceutical Industry with CE, FDA, GMP, and ISO standards.

Fully Automatic Control: PLC technology with 21CFR PART11 compliance and online hot water disinfection.

Customized Dimensions: Weight and Size are fully customized to meet specific project requirements.

Stainless Steel Construction: Made of Stainless Steel 304/316L with arc automatic welding for quality.

Energy Saving Design: Frequency-controlled pumps reduce microbial growth and save energy.

Modular & Compact: Modular design allows flexible configuration and compact structure.

Dual Supply Mode: Automatic circulation prevents stagnant water and ensures quality.

Flexible Recording: Options for paperless or paper recorders for real-time parameter tracking.

Company profile

High Repeat Buyers ChoiceMulti-language PioneerQuality AssuranceFull 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: ≤2.73h

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.