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Pharmaceutical Industry

In the pharmaceutical industry, strict guidelines apply for the hygienic design of plant components. In addition to safety and corrosion resistance, the operating conditions require high-purity Oberflächen so that any microbiological contamination can be ruled out.

The process lines are highly automated, häufige Product changes and media with difficult product properties are the order of the day. Therefore, the equipment components must have little dead space and be easy and quick to clean or sterilise between two production runs (CIP/SIP). The properties of the individual media such as purified water, chemicals for cleaning CIP or WFI systems or pure steam for SIP systems determine the requirements placed on the valves used.

Chromium-nickel-molybdenum steel (CrNiMo steel 316 L) is particularly suitable as the body material for valves. Deep drawing produces compact, high-quality and corrosion-resistant Oberflächen with low roughness, which can be further tempered e.g. by electropolishing. Elastomers are designed according to FDA and USP Class VI and can be damped up to 180°C.

Whether in the manufacture of injection or infusion solutions, for juices or drops in the pharmaceutical industry or for flash pasteurisers - Mankenberg's automatic industrial valves are an efficient solution for demanding processes in the pharmaceutical industry.

Laws and Guidelines for hygienic Fittings

UNITED NATIONS

  • WHO guidelines
  • ISPE Guidelines

EUROPEAN UNION

  • European Pharmacopoeia
  • EEC GMP Guidelines

AMERICA

  • FDA/cGmP Guidelines
  • CFR 21
  • US Pharmacopia

GERMANY

  • Medicines Act
  • German Pharmacopoeia
What our Products offer
  • Large selection of connections
    (aseptic flanges, TRI-CLAMP, ISO clamps…)
  • Completely made of stainless steel (1.4404 / 1.4435)
  • Surface quality up to Ra ≤ 0.25 μm
  • FDA conformity, USP class VI 121°C
  • Steam applications up to 180 °C
  • Electro-pneumatic control available
Product Features
  • EN 10204/2.1
  • EN 10204/3.1
  • Animal-derived free material certificate (TSE-free)
  • FDA (Food and Drug Administration)
  • USP Class VI (United States Pharmacopeia)
  • Welding documentation
  • VO (EG)1935/2004
pressure reducer DM 152
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References
  • Bayer
  • GSK (GlaxoSmithKline)
  • Pfizer
  • Novartis
  • Sanofi
  • Merck
  • Johnson & Johnson
  • AstraZeneca
  • Novo Nordisk
Application Reports
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