Is the control system compliant with 21CFR PART11?

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

What materials are used for the system?

The system is made of Stainless Steel 304 or 316L.

How quickly can you provide answers to inquiries?

We provide answers online within 24 hours.

High Efficiency Pharmaceutical Pure Water Machine Purified Water System with EDI

Name: High Efficiency Pharmaceutical Pure Water Machine Purified Water System with EDI
Brand: Shanghai Medigrade Industry Co., Ltd.
SKU: 1967734705

Shanghai, ChinaShanghai Medigrade Industry Co., Ltd.

US$10,000.00-15,000.00

1 set

Product profile

Customization

Available

Certification

CE, GMP, ISO

Core Components

PLC, Motor, Engine

Model NO.

MDR-1200

Weight

Customized

Function

Purified Water Preparation

Filter Material

RO Reverse Osmosis

Type

Pharmaceutical Water Treatment Equipment

Finished Dosage Form

Liquid

Precision

High Precision

Voltage

220V

Computerized

Customized

Condition

New

Warranty

1 Year

After-sales Service

Answers Online Within 24 Hours

Transport Package

Wood Case

Specification

Stainless steel

Trademark

Medigrade

Origin

China

HS Code

8421219990

Production Capacity

300 Sets/Year

Key features

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

Comprehensive Certification: Certified with CE, GMP, and ISO standards for pharmaceutical safety.

Advanced Control System: PLC automatic control with 21CFR PART11 compliance and multiple communication modes.

Thermal Disinfection Capability: System supports thermal disinfection for RO membranes and EDI modules.

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

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

Flexible Water Quality Output: Configurable to meet CP2010, USP34, and EP7 standards for purified or ultra-purified water.

24-Hour Online Support: Answers provided online within 24 hours for technical inquiries.

Company profile

Years of Export ExperienceHigh Repeat Buyers ChoiceCustomization from DesignsQuality Assurance

Shanghai Medigrade Industry Co., Ltd.

Shanghai, China

CertifiedBusiness Type: Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 10 years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤4.94h

AI-Powered supplier vetting

SummaryThe supplier offers filling, sealing, labeling, washing, packaging, capsule, tube, sachet, track-and-trace, and cartoning equipment or services, with product scope covering labeling, filling, packing, and capping machines. It reports OEM service for popular brands, ODM capability, and broad customization options. Production information includes five production lines, 11–20 quality-control staff, inventory capability, and twelve qualified service suppliers. However, the supplier has no overseas agents or branches, overseas warehouse, showroom, or offline trade-show participation, and offers no service in any stated country. Quality assurance is reported, but complaint handling, corrective/preventive actions, and supplier-service assessment lack written procedures or records. The supplier reports no new products in the past year and has no available SDK. Certification is listed only as “Others,” without a specified certification. Financial figures are excluded; the provided financial indicators are...

Supplier typeThe supplier is a limited company with no stated affiliation to a larger group. Its stated product scope includes labeling, filling, packing, and capping machines, while its description also covers multiple vial, ampoule, and packaging processes.

After-Sales capabilityThe supplier lists debugging, maintenance, repair, training, and equipment installation services, and has in-stock service capability. However, it has no overseas agents or branches, no overseas warehouse or showroom, no stated overseas service countries, and no written complaint-handling, corrective/preventive-action, or service-assessment procedures.

Production capacityThe supplier reports five production lines, 11–20 quality-control staff, inventory capability, quality assurance, and twelve qualified suppliers for service capability. It also reports one-month lead times in both peak and off-season data in one record, while another record states two-to-three-month production lead times, creating inconsistent timing evidence.

Customization capabilityThe supplier explicitly offers customization from samples, designs, full or minor customization, flexible customization, and ODM services. Its equipment and packaging-process description further supports relevance to customized filling, sealing, labeling, and packaging solutions.