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High-Quality cGMP Compliant Pure Steam Generator for Pharmaceuticals
US$27,000.00
1 Piece
Product profile
Customization
AvailableApplication
Biotechnology Industry, Chemical industry, Clinical Diagnosis, Energy & Mining, Food & Beverage Factory, Food Safety, Forensic Science, Pharmaceutical IndustryCapacity
100 L/hrModel NO.
100L/HCertification
CE, FDA, GMP, ISOControl System
Fully AutomaticTreatment Process
Chlorination, Electrodeionization, Filtration, Ozonation, Reverse Osmosis, Softening, Ultrafiltration, UV DisinfectionWarranty of core components
One YearModel
Psg-100Material
SS316LSurface Finish
Ra ≤ 0.4 μmStructure
Double Tube SheetHeating Source
Industrial Steam / ElectricSteam Dryness
≥ 0.95Non-Condensable Gas
≤ 3.5%Export Packaging
Vacuum + Wooden CaseWarranty
12 MonthsTransport Package
WoodenSpecification
otherTrademark
WEMACOrigin
ChinaHS Code
8419500020Production Capacity
One Piece / MonthKey features
cGMP & FDA Compliance: Strictly engineered for pharmaceutical and biotech facilities, ensuring compliance with FDA, USP, EP, and cGMP standards.
Zero Cross-Contamination: Double tube sheet structure creates a physical barrier between heating medium and pure steam, eliminating contamination risks.
Endotoxin-Free Steam: Triple-stage mechanical separation effectively removes liquid droplets, solid impurities, endotoxins, and non-condensable gases.
21 CFR Part 11 Support: Optional electronic records, audit trails, and user access management to meet strict pharmaceutical data integrity requirements.
Complete Validation Docs: Provides full DQ, IQ, OQ, PQ documentation, P&ID diagrams, and material certificates to reduce validation workload.
Flexible Heating Options: Supports both industrial steam and electric heating sources, adaptable to different plant infrastructure needs.
Company profile
Business Type: Manufacturer/Factory, Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service AvailableAverage Response Time: ≤3.32h
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 Pure Steam Generator has a capacity of 100 kg/h (100 L/hr).
Q:Does the system support 21 CFR Part 11 compliance?
A:
Yes, optional features include electronic records, audit trails, and user access management to support 21 CFR Part 11 compliance.
Q:What validation documentation is provided?
A:
We provide complete validation documentation including DQ, IQ, OQ, PQ, P&ID diagrams, material certificates, and FAT & SAT reports.
Q:What is the warranty period for core components?
A:
We provide a one-year warranty for core components.
Q:What are the available heating sources?
A:
The generator can be heated by either industrial steam or electric heaters, depending on your preference.
Send Inquiry
*To:
Shandong Eagle Pharma Machinery Co., Ltd.
Shandong Eagle Pharma Machinery Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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