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High-Quality cGMP Standard Pure Steam Generator for Pharmaceutical Applications
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: Designed per cGMP, ensuring compliance with FDA, USP, EP, and validation standards for pharmaceutical use.
Zero Cross-Contamination: Double tube sheet structure creates a physical barrier between heating medium and pure steam.
High Steam Purity: Triple separation technology removes droplets, particles, and endotoxins for dry, pyrogen-free steam.
Smart Control System: Siemens PLC + HMI with optional 21 CFR Part 11 audit trail and electronic records.
Complete Validation Support: Provides full DQ, IQ, OQ, PQ documentation and P&ID diagrams to reduce project timelines.
Flexible Heating Source: Optional plant steam or electric heating sources to suit different facility requirements.
12-Month Warranty: One-year warranty on core components with long-term spare parts availability and support.

Company profile

Shandong Eagle Pharma Machinery Co., Ltd.
In-stock CapacityQuality AssuranceR&D CapabilitiesFull Customization
Business Type: Manufacturer/Factory, Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service AvailableAverage Response Time: ≤3.16h

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 steam capacity of this generator?
A:
The steam capacity is 100 kg/h, suitable for pharmaceutical and biotech facilities needing WFI-grade clean steam.
Q:Does the system support 21 CFR Part 11 compliance?
A:
Yes, the control system offers optional 21 CFR Part 11 features including audit trails, electronic records, and user access management.
Q:What validation documents are provided?
A:
We provide complete validation documentation including DQ, IQ, OQ, PQ, P&ID diagrams, material certificates, and FAT & SAT reports.
Q:What after-sales services are offered?
A:
We provide remote technical guidance, optional on-site installation, long-term spare parts availability, and regular follow-ups.
Q:What is the warranty period for core components?
A:
The warranty for core components is one year, with long-term support to minimize system failures.

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