Does the system support electronic records?

Yes, the control system can be equipped with electronic signatures and records to meet 21 CFR Part 11 and GAMP5 requirements, including audit trail functions.

What certifications does the equipment have?

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

High-Efficiency Steam Generator for Lyophilization and SIP Use

Name: High-Efficiency Steam Generator for Lyophilization and SIP Use
Brand: Shandong Eagle Pharma Machinery Co., Ltd.
SKU: 1984686361

Shandong, ChinaShandong Eagle Pharma Machinery Co., Ltd.

US$37,000.00

1 Piece

Product specifications

CZQ1000

Product profile

Customization

Available

Application

Biotechnology Industry, Chemical industry, Food & Beverage Factory, Food Safety, Forensic Science, Pharmaceutical Industry

Certification

CE, FDA, GMP, ISO

Model NO.

1000KG

Control System

Automatic Control

Treatment Process

UV Disinfection

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

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 & cGMP Compliant: Meets GMP/cGMP standards for biopharma SIP equipment and sterilization.

Premium Material SS316L: All parts contacting water/steam use SS316L with electrochemical polishing.

Advanced Separation Tech: Three-stage separation with falling film evaporation and spiral flow.

Smart Control System: HMI+PLC automatic control with 3-level authority and optional SCADA.

Energy Efficient Design: 1:1.1 industrial steam to feed water ratio with heat exchange recovery.

Regulatory Compliance: Meets 21 CFR Part 11, GAMP5, and Pharmacopoeia CP2020/USP43/EP10.

Comprehensive Documentation: Provides FAT reports, weld diagrams, and verification 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: ≤3.40h

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: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?

We offer two options: 1) Send engineers for commissioning (buyer bears airfare, visa, accommodation, and labor costs). 2) Provide online services with free parts during warranty (buyer bears shipping costs).

Q:What is the warranty period?

We provide a standard 12-month warranty period, commencing upon completion of installation.

Q:Is technical support available?

Yes, free remote technical support is provided via video and phone communication throughout the warranty period.

Q:What materials are used for construction?

SS316L is used for all parts in contact with feed water, pure steam, and condensed water, with electrochemical polishing for internal and external surfaces.