Reliable Clean Steam Solutions for Pharmaceutical Injection Applications

Customization:	Available
Application:	Clinical Diagnosis, Forensic Science, Pharmaceutical Industry
Disposable:	No

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Basic Specifications

Model NO.

PSG-500

Material

316L/304 Stainless Steel

Steam Output

50 - 5,000 Kg/H (Customizable)

Working Pressure

up to 5 Bar (G)

Control System

PLC with Color Touch Screen HMI

Compliance

USP, EP, JP, cGMP, GAMP

Surface Finish

Ra ≤ 0.6 µm (Internal Electropolished)

Origin

China

HS Code

84198990

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Product Description

Our high-performance Pure Steam Generator is masterfully crafted to deliver 100% pure, pyrogen-free steam that aligns with the stringent international pharmacopoeia standards, including USP, EP, and JP. This solution is indispensable for critical applications across the pharmaceutical, biotechnology, and cosmetic sectors where uncompromised steam purity is essential.

Expertly constructed from 316L stainless steel with an internal electropolished finish (Ra ≤ 0.6µm), our generator ensures unparalleled corrosion resistance and prevents particle shedding. The innovative tubular heat exchanger design ensures that feed water remains completely isolated from unclean steam, resulting in steam of extraordinary quality.

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Key Features & Advantages

Guaranteed Pure Steam Quality: Consistently produces condensate that adheres to the rigorous requirements for Water for Injection (WFI).

Superior Construction: Crafted from premium 316L stainless steel. All wetted components are precisely electropolished to significantly reduce microbial adhesion.

Efficient Tubular Heat Exchanger: Ingenious design ensures optimal heat transfer efficiency and complete separation between pure and plant steam.

Fully Automated Operation: Boasts a user-friendly PLC + HMI control system for seamless automatic operation and comprehensive data logging.

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Technical Parameters

Steam Output	50 - 5,000 kg/h (Customizable)
Design Standard	ASME BPVC Section VIII, Div. 1 or PED 2014/68/EU
Working Pressure	Up to 5 bar (g) (Customizable)
Heat Exchanger Material	316L Stainless Steel, Electropolished
Shell Material	304 or 316L Stainless Steel
Surface Finish	Ra ≤ 0.6 µm (Electropolished) internally
Compliance	cGMP, GAMP
Lead Time	60 days (1 - 1 Pieces)

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Frequently Asked Questions

What standards does the pure steam comply with?

The pure steam produced adheres to the most rigorous international pharmacopoeia requirements, including USP, EP, and JP standards for Water for Injection (WFI).

What materials are used for the wetted parts?

All wetted parts and the heat exchanger are constructed from high-grade 316L stainless steel with an internal electropolished finish (Ra ≤ 0.6µm) for maximum purity.

Is the control system automated?

Yes, the system features a fully automated PLC + HMI (Touch Screen) control system that allows for seamless operation, data logging, and compliance with GAMP guidelines.

Can the steam output be customized for my project?

Absolutely. We offer customizable steam output capacities ranging from 50 kg/h to 5,000 kg/h to suit specific pharmaceutical or laboratory requirements.

What kind of documentation is provided for validation?

We provide comprehensive validation documentation including DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

What certifications are available for the pressure vessels?

Our pure steam generators can be manufactured to comply with ASME BPVC Section VIII or PED 2014/68/EU standards based on your regional requirements.