Advanced Pure Steam Generator for Cell Therapy Systems

Name: Advanced Pure Steam Generator for Cell Therapy Systems
Brand: Shandong Eagle Pharma Machinery Co., Ltd.
SKU: 1989299591

Shandong, ChinaShandong Eagle Pharma Machinery Co., Ltd.

US$35,000.00-45,000.00

1 Piece

Product specifications

CZQ1000

Product profile

Customization

Available

Theory

Pressure Steam

Type

Pressure Steam Sterilization Equipments

Model NO.

CIP

Certification

CE, FDA, ISO13485

Electric Tension

380V

LCD Display

Without LCD Display

Ultra High Temperature Alarm

Sterilization Information Recording and Printing

Material

Stainless Steel

Feed Water

Purified Water

Heating Source

Industrial Steam

Separation Device

Three Stage Separation Device

Structure Form

Double Tube Plate Design

Insulation

Glass Fiber Needle Wire Mat

Surface Treatment

Electric-Chemical Polishing

Control System

Automatic Control

Recording

Paperless or Paper Two Options

Permission Level

Three Levels

Optional1

Electronic Signature(21 CFR Part 11 )

Optional 2

Audit Trail

Optional 3

Scada

Transport Package

Wood Packing

Specification

CZQ1000

Trademark

WEMAC

Origin

Weifang

HS Code

8419409090

Production Capacity

1000kg

Key features

GMP Compliant Pure Steam: Meets CP2020, USP43, and EP10 standards for water for injection specifications.

SS316L Construction: All parts contacting feed water and steam are made of SS316L stainless steel.

3-Stage Separation: Uses falling film evaporation, gravity separation, and spiral flow for high purity.

21 CFR Part 11 Ready: Optional electronic signature and audit trail functions for regulatory compliance.

Energy Efficient Design: Industrial steam to feed water ratio of 1:1.1 with waste heat recovery system.

Automatic PLC Control: HMI+PLC full-automatic control with multi-level authority and online monitoring.

Electrochemical Polishing: Internal and external surfaces polished to ensure high finish and corrosion resistance.

Comprehensive Documentation: Provides weld diagrams, pressure test reports, and system design documents.

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: ≤4.32h

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 warranty period and what does it cover?

Standard warranty is 12 months from installation completion. It includes free remote technical support via video/phone and free replacement of non-human damaged components. Shipping costs for parts are borne by the buyer.

Q:How can I visit your factory?

You can fly to Qingdao Airport, Shandong. Our company will arrange a car to pick you up directly from the airport and transfer you to our factory for a visit.

Q:What installation services are provided?

Option 1: Engineers visit for commissioning/maintenance; buyer bears airfare, visa, accommodation, and labor costs. Option 2: Online services provided; if under warranty, free accessories/parts provided, buyer bears shipping costs.

Q:Is the equipment customizable for specific needs?

Yes, options include electronic signature (21 CFR Part 11), audit trail, SCADA integration, and paperless or paper recorders. Dimensions can also be adjusted based on room space.

Q:What certifications does the equipment hold?

The equipment holds CE, FDA, and ISO13485 certifications, complying with the Machinery Directive and Electromagnetic Compatibility Directive.