Outstanding quality
In almost no other area of production are there higher requirements for the purity of the product than in the production of active pharmaceutical ingredients. Ensuring sterility and avoiding microbial contamination is the primary goal.
The manufacturing processes in the pharmaceutical industry are therefore subject to the strictest system and product quality demands as well as high safety requirements.
Our decades of experience in the development, design and production of diaphragm valves, coupled with our knowledge of the special requirements of sterile process engineering, make SISTO a leading manufacturer of diaphragm valves.
“In order to meet the high demands of sterile applications, all our production steps, from the purchase of raw materials through the various stages of manufacturing to the finished product, are subject to stringent quality controls.”
– Philipp Gaudlitz, Managing Director SISTO Armaturen S.A.
Milling 
Surface finishing 
Visual check 
Electropolishing 
Cleaning 
Cleaning 
Laser marking 
Tightness test 
Assembly Deep value chain, high flexibility
To maintain a consistently high quality level, all quality-impacting production processes are carried out at SISTO’s own factory: From turning and milling with modern 5- to 9-axis machinery to surface machining and electro-polishing. Even the vulcanisation process of diaphragms takes place in-house. Not only does this setup allow an end-to-end quality assurance, it also gives us the flexibility to manufacture customised designs and in small batch sizes.
A wide range of variants comprising simple straight-way valves, welded designs and complex multi-port valve blocks means that SISTO can offer customised solutions for every type of application which comply with relevant standards (e.g. ASME BPE).
In addition, SISTO undergoes constant monitoring by independent testing institutes.
Approvals & Certificates
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Certification
ISO 9001
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Certification
ISO 14001
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Certification
ISO 45001
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Certification
CE certificate (2014/68/EU)
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Certification
AD2000 / DIN EN ISO 3834
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Declarations of conformity DGRL 2014/68/EU
PED 2014/68/EU
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EU1935/FDA
Diaphragms TFM/EPDM
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EU1935/FDA
Diaphragms EPDM (SE1203)
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USP
Diaphragms TFM bonded
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USP
Diaphragms TFM/EPDM 2-piece
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USP
Diaphragms EPDM (SE1203)
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ATEX
Declaration by manufacturer
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ADI
Declaration by manufacturer