What is the steam capacity of this generator?

The steam capacity is 100 kg/h (100 L/hr), designed for WFI-grade steam production.

How does the system ensure steam purity?

It uses a double tube sheet structure to prevent cross-contamination and triple separation technology to remove droplets, particles, and endotoxins.

Premium Pharmaceutical Steam Generator with cGMP Compliance for Reliable Production

Name: Premium Pharmaceutical Steam Generator with cGMP Compliance for Reliable Production
Brand: Shandong Eagle Pharma Machinery Co., Ltd.
SKU: 2143100162

Shandong, ChinaShandong Eagle Pharma Machinery Co., Ltd.

US$27,000.00

1 Piece

Product profile

Customization

Available

Application

Biotechnology Industry, Chemical industry, Clinical Diagnosis, Energy & Mining, Food & Beverage Factory, Food Safety, Forensic Science, Pharmaceutical Industry

Capacity

100 L/hr

Model NO.

100L/H

Certification

CE, FDA, GMP, ISO

Control System

Fully Automatic

Treatment Process

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

Warranty of core components

One Year

Model

Psg-100

Material

SS316L

Surface Finish

Ra ≤ 0.4 μm

Structure

Double Tube Sheet

Heating Source

Industrial Steam / Electric

Steam Dryness

≥ 0.95

Non-Condensable Gas

≤ 3.5%

Export Packaging

Vacuum + Wooden Case

Warranty

12 Months

Transport Package

Wooden

Specification

other

Trademark

WEMAC

Origin

China

HS Code

8419500020

Production Capacity

One Piece / Month

Key features

cGMP & FDA Compliance: Engineered per cGMP, compliant with FDA, USP, EP standards for pharmaceutical validation.

Zero Cross-Contamination: Double tube sheet structure separates heating steam and pure steam to prevent cross contamination.

Endotoxin Control: Triple separation technology removes liquid droplets, solid impurities, and endotoxins effectively.

Complete Validation Support: Provides DQ, IQ, OQ, PQ documentation and P&ID diagrams to reduce customer validation workload.

Intelligent Automation: Siemens PLC + HMI system with automatic startup, shutdown, and optional 21 CFR Part 11 features.

Flexible Heating Options: Heating source can be industrial steam or electric, adaptable to various plant utilities.

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: ≤2.63h

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 the warranty period for core components?

We provide a one-year warranty for core components and offer long-term after-sales service with regular follow-ups.

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

Yes, the control system offers optional features including audit trails, electronic records, and user access management compliant with 21 CFR Part 11.

Q:What validation documentation is provided?

We provide complete validation documentation including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), along with P&ID diagrams and material certificates.

Q:What are the available heating sources for the generator?

The heating source can be either industrial steam or electric, depending on your plant's utility requirements.

Q:Is installation service available?

Yes, we provide remote technical guidance and optional on-site installation and commissioning services.