Pure Steam Generator

Industry Standards

1. Southeast Asia Standards：Malaysia: American ASME Standards, British BS1633 Standards，Indonesia: ISPE Guidelines, EU Aseptic Preparation Standards, WHO (World Health Organization) Requirements, British Sterilization Standard HTM 2010, European Standard EN 285

2. Europe & America Standards：United States: United States Pharmacopeia (USP-NF 2025), ASME BPE (Bioprocessing Equipment Standard)，European Union (EU): European Pharmacopoeia (EP 12.0), British Sterilization Standard HTM 2010, European Standard EN 285

3. Middle East Standards：United States Pharmacopeia (USP-NF 2025), European Pharmacopoeia (EP 12.0), American ASME Standards

4. Africa Standards：American ASME Standards, European Standard EN 285

二、Basic Parameters

Design Features

• This product is designed and manufactured in compliance with the latest GMP and FDA standards, adopting a multi-stage vapor-liquid separation method.

• Using purified water as feed water, it is heated by industrial steam (or electricity) to produce sterile and pyrogen-free pure steam, featuring fast steam generation and high purity.

• Compact footprint, safe, easy and reliable operation.

Product Advantages

• The equipment features high modularization, standardization, and serialization.

• Dual-shell seamless tube sanitary exchanger, compliant with cGMP requirements, effectively eliminating medium contamination.

• The entire equipment is made of AISI 316L stainless steel, with the cylinder and exchanger working surfaces subjected to standard pickling and passivation treatment.

• All sealing rings are made of pharmaceutical-grade polytetrafluoroethylene material.

• The pure steam quality meets the requirements for non-condensable gas content, dryness, and superheat as defined in the HTM2010 (EN285) standard.

Product Parameters

Price：As it is a non-standard product, the price needs to be quoted based on specific requirements.