What certifications are available?

The generator is designed to ASME BPVC Section VIII, Div. 1 or PED 2014/68/EU standards, with certifications available upon request.

What is the warranty period?

We provide a one-year warranty for the equipment.

Advanced cGMP Compliant Pure Steam Generator for Medical Use

Name: Advanced cGMP Compliant Pure Steam Generator for Medical Use
Brand: Shandong Eagle Pharma Machinery Co., Ltd.
SKU: 2124804632

Shandong, ChinaShandong Eagle Pharma Machinery Co., Ltd.

US$60,000.00

1 Piece

Product profile

Customization

Available

Application

Clinical Diagnosis, Forensic Science, Pharmaceutical Industry

Disposable

Model NO.

PSG-500

Injection Site

Subcutaneous

Material

Stainless Steel

Needle Gauge

18G

Safety Feature

Auto-Retractable Needle, Locking Mechanism

Usage

Medical

Warranty

One Year

Steam Output

50 - 5,000 Kg/H (Customizable)

Working Pressure

up to 5 Bar (G) (Customizable)

Shell Material

304 or 316L Stainless Steel

Control System

PLC with Color Touch Screen HMI

Sterilization-in-Place (SIP)

for Sterilizing Bioreactors, Fermenters, Piping, a

Pure Steam for Humidification

in Cleanrooms and Controlled Environments

Preparation of Water for Injection (Wfi)

Used as The Thermal Source in Wfi Distillation Uni

Laboratory and R&D Use

Providing High-Purity Steam for Research Applicati

Transport Package

Wooden Package

Specification

other

Trademark

WEMAC

Origin

China

HS Code

84198990

Production Capacity

One Piece / Month

Key features

cGMP & USP/EP/JP Compliance: Produces 100% pure, pyrogen-free steam meeting strict pharmacopoeia standards.

Advanced Tubular Heat Exchanger: Ensures complete segregation of pure steam from plant steam, preventing contamination.

Fully Automated PLC Control: Features HMI touch screen, data logging, and password protection for GAMP compliance.

Customizable Capacity: Steam output adjustable from 50 to 5,000 kg/h to fit specific project needs.

Energy Efficient Design: Optimized structure significantly reduces energy and water usage, lowering operational costs.

Comprehensive Validation Support: Provides DQ, IQ, OQ, PQ documentation and technical support for seamless installation.

ASME/PED Certified: Designed to ASME BPVC Section VIII or PED 2014/68/EU standards for global safety.

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: ≤4.35h

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.