Products
Sterile shell-and-tube heat exchanger
WFI / product cooler/heater · CIP-solution heat exchanger · Exhaust air cooler / condenser · Exhaust air heater
For sensitive pharmaceutical media, heat exchangers with a double tube sheet (DTS) and hygienic geometry provide safe and controlled media separation. Each design is matched to the customer’s specific requirements. On the product-contact side, a surface finish down to Ra ≤ 0.4 µm is possible.
Hygienic design features
Pharma heat exchangers from ETS: designed in Tübach, manufactured within the APL Group. They meet the demanding requirements of the US Food and Drug Administration (FDA) and all cGMP guidelines. ETS AG offers high-quality shell-and-tube heat exchangers for use in FDA-regulated facilities, to cool or heat liquids or gases without causing contamination by bacteria or other microorganisms.
Double tube sheet (DTS)
A double tube sheet ensures extensive separation of the primary and secondary media. Leaks drain off without pressure.
Can be designed to be drainable
The product side is free of any dead space. The special geometric arrangement of the top and bottom tubes allows the tube side to be completely drained and vented. The shell side is drained and vented via connections or bores in the inner tube sheets.
Ra ≤ 0.4 µm finish
Product-contact surfaces are mechanically ground and electropolished if required. Heat exchanger tubes are seamless and electropolished. The seamless tubes prevent the adhesion of microbes and particles.
Insulation cladding
The insulation is clad with fully welded, matte-ground stainless steel sheet. Durable, cleaning-resistant and hygienic.
Double tube sheet for separated media
The design principle prevents media mixing through the use of double tube sheets. The heat exchanger is sterilizable and thus meets absolute purity conditions. For additional safety, expansion joints are used and checked for thermal stresses.
Connections, dimensions, surfaces and documentation are defined for the respective task according to the process data.
The DTS system (Double Tube Sheet) consists of two separate tube sheets at the ends of the heat exchanger. The tubes are rolled and welded into both plates:
- Product space separation: The pharmaceutical product flows through the tubes and is sealed on the product side by the inner tube sheet.
- Cooling medium separation: The heating or cooling medium (e.g., water-glycol) flows in the shell and is sealed on the shell side by the outer tube sheet.
- Leak monitoring space: If a leak occurs at a tube-to-tube-sheet joint, the medium escapes without pressure into the gap between the two tube sheets and is drained off through a bore before it can mix with the other medium.
A binding DTS section drawing is agreed after engineering approval.
Technical data
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Typical fields of application for this heat exchanger type
Single- and multi-pass designs
Single- or multi-pass designs are available depending on flow velocity and temperature profile.
Design, number of passes, and connections are sized from the process conditions.
Sizes shown (new tab)1-pass design
2-pass design
Applications in pharma and biochemistry
Used in the pharmaceutical industry and in biochemistry – where the product itself flows through the unit and the plant is cleaned in CIP/SIP operation. Thanks to standardized components available from stock, our sterile shell-and-tube heat exchangers are competitive and available at short notice.
- WFI cooler
- Product cooler and heater
- CIP-solution heat exchanger
- Exhaust air heater
- Exhaust air cooler and condenser
Testing and documentation
Design and acceptance in accordance with PED. The scope of documentation is agreed on a project-specific basis and can include material certificates, weld documentation and test records.
Ferrite content ≤ 3%
Minimized risk of rouging and corrosion.
Ra ≤ 0.4 µm
Electropolished to prevent microbial contamination.
Helium leak test
Detection of micro-cracks down to 10⁻⁹ mbar·l/s.
Validation documents
Complete traceability for the FDA.
Downloads
Product brochure
Sterile shell-and-tube heat exchanger
Frequently asked validation questions
Answers on documentation, drainability and design.
Which test and material documents are supplied?
The scope of documentation is agreed per order. Typical items are 3.1 material test certificates, delta-ferrite verification of the weld seams, roughness records of the product-contact surfaces, weld documentation, and records of the pressure test, dye penetrant testing (PT), X-ray testing and helium leak test. The O-ring seal is supplied with an FDA or USP Class VI certificate. This does not imply an FDA certificate for the entire unit.
How is complete drainability physically ensured?
For horizontal installation, the heat exchanger must be mounted with a slight downward slope. Positioning the topmost and bottommost tubes exactly at the casing boundaries (tangential outlet) ensures that residual liquid drains completely from the product side – no stagnant water remains.
Can the unit be designed to ASME-BPE?
Yes, tube geometries, tube wall thicknesses, flange designs (Tri-Clamp / ASME-BPE) and surface finishes can be designed to the requirements of the ASME-BPE guidelines for piping components in the biopharma sector.
Secure your ultrapure water and pharma processes
Send us your process parameters for the calculation of the WFI or product cooler. Our engineers take the agreed cGMP requirements into account in the design. Fill out the contact form and one of our team members will respond as quickly as possible.
If you have questions, we are available by phone. Discuss your requirements with one of our knowledgeable team members. We are happy to assist you personally.