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High-Quality cGMP Standard Pure Steam Generator for Pharmaceutical Applications
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: 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
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.
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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