Does the control system support audit trails and electronic signatures?

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

What certifications does the equipment hold?

The equipment is certified with CE, GMP, and ISO.

Premium CE Certified Pure Steam Generator for Pharmaceutical Applications

Name: Premium CE Certified Pure Steam Generator for Pharmaceutical Applications
Brand: Shandong Eagle Pharma Machinery Co., Ltd.
SKU: 1988612091

Shandong, ChinaShandong Eagle Pharma Machinery Co., Ltd.

US$34,000.00

1 Piece

Product specifications

500kg

Product profile

Customization

Available

Application

Chemical Industry, Cosmetic Industry, Food Industry, Pharmaceutical Industry

Certification

CE, GMP, ISO

Model NO.

CZQ500

Control System

Fully Automatic

Customized

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

Transport Package

Wood Packing

Specification

CZQ500

Trademark

WEMAC

Origin

Weifang

HS Code

8419409090

Production Capacity

500kg

Key features

Pharma Grade Compliance: Condensate meets CP2020, USP43, and EP10 standards for water for injection.

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

Advanced Separation Technology: Three-stage separation with falling film evaporation, gravity separation, and spiral flow.

Fully Automatic Control System: HMI+PLC control with electronic signature, audit trail, and 21 CFR Part 11 compliance.

Energy Saving Design: Utilizes waste heat and condensate preheating to maximize energy efficiency and reduce consumption.

High Quality Welding: Argon gas protection automatic welding with post-weld electrochemical polishing to prevent contamination.

CE, GMP, ISO Certified: Equipment holds CE, GMP, and ISO certifications ensuring international quality standards.

Customizable Configuration: Customized options available for feed water, heating source, separation device, and structure form.

Company profile

High Repeat Buyers ChoiceMulti-language PioneerQuality AssuranceFull 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: ≤3.01h

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 many years of experience do you have in the pharmaceutical industry?

We have 67 years of experience in pharmaceutical water equipment.

Q:What installation services do you provide?

We provide two options: 1) On-site commissioning and maintenance by our engineers (travel, visa, accommodation, and labor costs borne by the buyer). 2) Online services.

Q:Are spare parts provided during the warranty period?

If the equipment is under warranty, necessary accessories and parts will be provided free of charge, but the shipping costs will be borne by the buyer.

Q:What standards does the pure steam condensate meet?

The condensate meets the requirements of Chinese Pharmacopoeia (CP2020), U.S. Pharmacopoeia (USP43), and European Pharmacopoeia (EP10) for water for injection.

Q:What material is used for parts contacting the steam and water?

SS316L stainless steel is used for all parts in contact with feed water, pure steam, and pure steam condensed water.