Sterile heat exchanger

Sterile heat exchanger as WFI / product cooler / heater - CIP solution heat exchanger - air cooler / condenser - exhaust air heater


ETS AG offers high-quality shell-and-tube heat exchangers that meet all cGMP guidelines and are ideal for use in FDA systems to cool or heat liquids or gases without causing contamination from bacteria or other microorganisms.

Thanks to the DTS structure, extensive separation of the primary and secondary medium is ensured.

The tube side of the heat exchanger is completely drained and vented because the top and bottom tubes are specially positioned. The insulation is covered with ground stainless steel sheet to ensure a long service life. For additional safety, compensators are used and tested for thermal stresses.

By standardizing the components, our sterile tube bundle heat exchangers are competitive and can be delivered quickly.

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Product features

  • cGMP compliant according to current guidelines
  • Double tube plate DTS
  • Dead space-free design of the product page
  • Pipe and casing side can be completely drained and ventilated
  • Sterile connections on the product side
  • Surface roughness of the parts in contact with the product up to Ra ≤ 0.4 µm (ground and electropolished if necessary)
  • Heat exchanger tubes seamless and electropolished
  • O-ring seal with FDA or USP Class VI certificate
  • Single or multi-flow version
  • Horizontal or vertical installation
  • Insulation with stainless steel coating
  • Compensator possible
  • Materials: 1.4435, 1.4404, 1.4539 and other high-alloy stainless steels
  • Ferrite content ≤ 2%

Areas of application

  • Pharmaceutical industry
  • Biochemistry

Tests and acceptance

  • Pressure test
  • PT – Exam
  • X-ray – examination
  • Helium leakage test
  • Cleaning protocol
  • Execution and acceptance according to PED

Variants

  • Sterile tube bundle heat exchanger in 1-pass design
  • Sterile tube bundle heat exchanger in 2-pass design
  • Sterile tube bundle heat exchanger in 3-pass design
  • Sterile tube bundle heat exchanger in 4-pass design