Versatile GMP Standard Water Distiller for Pharma Applications

Name: Versatile GMP Standard Water Distiller for Pharma Applications
Brand: Shandong Eagle Pharma Machinery Co., Ltd.
SKU: 2147136672

Shandong, ChinaShandong Eagle Pharma Machinery Co., Ltd.

US$10,000.00

1 Set

Sample price:US$10000.00/set.Request sample

Product profile

Customization

Available

Application

Biotechnology Industry, Pharmaceutical Industry

Capacity

1500lph

Model NO.

LDS 1500L/H

Certification

CE, FDA, GMP, ISO, USP./Ep/Cp

Control System

Fully Automatic

Treatment Process

Chlorination, Electrodeionization, Filtration, Reverse Osmosis, Softening, Ultrafiltration, UV Disinfection

Warranty of core components

2 Years

Contact Part Material

SS316

Surface Polish

Electric Chemical Polished

Surface Roughness

Less Than 0.4

Spares

Heat Exchanger,High Pressure Pump Valves etc

Distillation Technology

Multi-Effect Thermal Compression Distillation

Compliance Standard

GMP, cGMP, FDA, ASME Bpe, Ep, USP

Water Quality Standard

Meets Wfi (Water for Injection) Requirements

Data Traceability

Automatic Data Recording & Audit Trail

Working Temperature

100℃ - 130℃

Warranty Period

18 Months with Lifelong Technical Support

Working Pressure

0.3MPa - 0.8MPa

Transport Package

Wooden Package

Specification

1500L/H

Trademark

WEMAC

Origin

China

HS Code

8419409090

Production Capacity

1000sets/Year

Key features

Full GMP & Global Pharmacopoeia Compliance, produces certified WFI matching CP2020, USP, EP, JP standards for all pharmaceutical production

Wide pharmaceutical versatility: applicable for injectables, eye drops production, sterile formulation, medical device washing & lab research

Double tube-sheet condenser design, completely prevents cross-contamination between raw water and finished WFI

PLC+HMI fully automatic control system compliant with GAMP5 & 21CFR Part11, real-time monitoring of conductivity, TOC, temperature & pressure

Complete validation document package (DQ/IQ/OQ/PQ/FAT/SAT) + CE, ISO9001 certification, supports FDA factory audit

Low maintenance structure with argon shield fully welded sanitary piping, long service life & low operation cost

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: ≤1.67h

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.

Product Q&A

Q:What is a multi-effect distiller used for in pharmaceutical production?

The multi effect distiller is core pharmaceutical water equipment designed to produce high purity Water for Injection (WFI). It uses purified water as feed water and industrial steam as heat source, fully complying with USP, EP and cGMP standards for pharma formulation, LVP preparation and sterile process rinsing.

Q:What is the material construction of your multi-effect distiller?

The whole equipment housing and all wetted parts adopt **316L stainless steel**. The internal surface is treated with **electrolytic polishing** to achieve ultra-smooth finish, no dead corners, no residue accumulation, effectively preventing bacterial growth and cross-contamination.

Q:What WFI quality can this distiller guarantee?

The output WFI meets global pharmacopoeia standards. Stable conductivity, low TOC, zero pyrogen and low microbial count. Online real-time monitoring ensures unqualified water is automatically drained to guarantee consistent water quality.

Q:Does the system support 21 CFR Part 11 and GAMP5 compliance?

The control system supports complete audit trail, user permission management, electronic records and electronic signature, fully compliant with FDA 21 CFR Part 11 and GAMP5 for pharmaceutical data integrity requirements.

Q:What validation documents can you provide?

Complete DQ, IQ, OQ, PQ and CSV validation documents are available, together with weld inspection reports, passivation records and borescope reports to support factory audit and global regulatory inspection.