1 Description
1.4
Design
The Pharma-line is in hygienic design in accordance with FDA guidelines. The Pharma-line has no dead legs and is fully drainable
on the product side. All product wetted parts in the Pharma-line are either electropolished to Ra <0.4 µm, or mechanically
polished to Ra <0.5 µm or Ra <0.8 µm.
The tubes are seamless and polished prior to bending. The Pharma-line U-tubes are bent to a larger radius than required in
ASME BPE. The Pharma-line is easy to clean and can be steam sterilized. The gaskets are FDA approved and USP class VI.
Working principles
In the Pharma-line the risk of mixing between the product and the heating or cooling (service) medium is eliminated as a result
of the double tube sheet design. The product flows in the tubes while the service medium flows in a cross flow around the
tubes, inside the shell. The service medium is sealed in the shell by the first tube sheet and the second tube sheet seals the
product. In the event of a leak the leakage of either fluid is easily visually detected.
5300-0000
A
A = Tube sheets
Documentation
The Pharma-line is delivered along with a complete documentation package, including
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Approved drawings and pressure test certificate signed by Notified body according to ASME VIII division 1 classified
Pharma-lines and Pharma-lines classified in category > III according to PED (97/23/EC). For Pharma-lines in category •
III Zetterströms Rostfria AB is certified to approve drawings and issue pressure test certificate for PED (97/23/EC) under
Lloyds register (NB.No 0038)
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List of welders, welding procedure and welder qualification
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3.1 Material certificates pressure and product wetted steel parts
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FDA and USP class VI certificates gaskets
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Liquid penetrant test report and procedure
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Surface roughness certificate
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Dimension control report
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Pressure test certificate
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Identification (technical sign)
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Quality system certificate
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CE documents
Other documentation/procedures on request.
5
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