What certifications does the product hold?

The product holds CE, FDA, GMP, and ISO certifications.

GMP and ISO Certified Steam Generator for Pharmaceutical Sterilization

Name: GMP and ISO Certified Steam Generator for Pharmaceutical Sterilization
Brand: Shandong Eagle Pharma Machinery Co., Ltd.
SKU: 2141828802

Shandong, ChinaShandong Eagle Pharma Machinery Co., Ltd.

US$20,000.00

1 Set

Sample price:US$20000.00/set.Request sample

Product profile

Customization

Available

Application

Pharmaceutical Industry

Capacity

100kg/H

Model NO.

PSG100KGH

Certification

CE, FDA, GMP, ISO

Control System

Fully Automatic

Treatment Process

High Temperature

Warranty of core components

2 Years

Material

SS316L

Evaporator

Double Tube Sheet Plate Heat Exchanger

Roughness

Less Than 0.4

Polish

Electric Chemical Polished

Document

Dq Iq Oq Pq Fat Sat

Transport Package

Wooden Package

Specification

100KG/H

Trademark

WEMAC

Origin

China

HS Code

8419409090

Production Capacity

1000sets/Year

Key features

GMP and ISO Certified: Certified by CE, FDA, GMP, and ISO for pharmaceutical sterilization applications.

SS316L Material: Constructed with SS316L stainless steel for superior corrosion resistance.

Multiple Capacity Options: Available in capacities ranging from 100kg/H to 3000kg/H.

Full Validation Documents: Provides DQ, IQ, OQ, PQ, FAT, and SAT documentation upon request.

2-Year Core Warranty: Core components covered by a comprehensive 2-year warranty period.

Electric Chemical Polish: Surface finish polished to less than 0.4 roughness via electric chemical process.

Double Tube Sheet Design: Features a double tube sheet plate heat exchanger evaporator for safety.

Global Export Experience: Exported to over 40 countries including Europe, Asia, Africa, and South America.

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: ≤3.13h

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.