Applications in the Pharmaceutical Industry

The Industry

Strict guidelines for the hygienic execution of plant components have long been applicable to the pharma industry. In addition to safety and corrosion resistance, the operating conditions require ultrapure surfaces in order to avoid any microbiological contamination.

 

The process lines are highly automated, and frequent product changes as well as media with challenging product characteristics are part of the day-to-day business. Consequently, the equipment components must necessarily be free from dead spaces and fast and easy to clean or to sterilise (CIP/SIP) between two production runs. The characteristics of single media such as purified water, chemicals for cleaning CIP or WFI plants or ultrapure steam for SIP plants determine what is required for the deployed valves.

 

Chromium-nickel-molybdenum steel (CrNiMo steel 316L) is particularly suitable for the valve body. Deep-drawn surfaces are compact, of high quality and corrosion-resistant and feature low roughness. They can further be electropolished. Elastomers are designed in accordance with FDA and USP Class VI and can be exposed to steam up to 180°C.

 

Whether for the fabrication of solutions for injection and infusion, for medicinal syrup or drops or flash pasteurisers – the self-acting industrial valves from Mankenberg are an efficient solution for challenging processes in the pharma industry.

Laws and Guidelines for Hygienic Valves

world map

United Nations

» WHO Guidelines

» ISPE Guidelines

 

European Union

» European Pharmacopia

» EEC GMP-Guidelines

Amerika

» FDA/CGmP Guidelines

» CFR 21

» US Pharmacopia

Germany

» Pharmaceutical Law

» German Pharmacopia

Approvals and Material Certificates

Stempel FDA approved» EN 10204/2.1

» EN 10204/3.1

» EN 10204/3.1

» FDA (Food and Drug Administration)

» USP Class VI (United States Pharmacopeia)

» Animal-derived free material certificate (TSE-free)

» Surface certificate

» Welding seam documentation

» VO (EG) 1935/2004

Product Requirements

Pharmaventil Druckminderer DM 462V» Laws & guidelines for hygienic valves

» High purity (SIP  & CIP)

» High-quality materials such as stainless steel 316 L

» Special connections

» Virtually free from dead spaces, residue-free draining

» Complete documentation of the fabrication process

» Surface quality (Ra ≤ 0,8 µm)

» Permanent marking

» Temperature-resistant up to 180 °C

» Pressure-resistant up to 16 bar

» Ozone-resistance in sterilisation processes with ozone

» Compliant with the German Clean Air Act

Advantages of Mankenberg Products

» Various connection possibilities (aseptic flanges, TRI-CLAMP, ISO clamps …)

» Stainless steel 316L (CrNiMo)

» Surface quality Ra ≤ 0,25 μm possible

» Eastomers as per FDA and USP Class VI, hygiene class HE5

» Can be exposed to steam up to 180 °C

» Can be dome-loaded

» Spring cap with leakage line connection and adjusting screw seal is available

Typical used Products

Our pressure regulators sorted by flowrate and available surface quality:

 

Übersicht verwendete Produkte in der Pharmaindustrie

 

Other products:

 

Produktübersicht für die Pharmaindustrie sonstige Ventile

Applications

pharma-anwendung-druckminderer-dm462   pharma-anwendung-druckminderer-dm462   pharma anwendung druckminderer dm 505
Pressure Reducer DM 462
Regulation of the Water Supply for a Centrifuge Test Stand
Pressure Reducer DM 462
No Pure Steam – no Pharmaceutical Factory
Pressure Reducer DM 505
Reducing the Sterile Air Pressure in an Ampoule Filling Machine
     
pharma-anwendung-Wasserabscheider-AS2        
Liquid Separator AS 2
Corrosion Resistance in Clean Steam Systems

 

 

References

Bayer, GSK (GlaxoSmithKline), Pfizer, Novartis, Dräger Medical, Baxter, F. Hoffmann – La Roche, Optima Group, Merck,  Sanofi – Aventis, Bausch & Ströbel

 

Weiterführende Informationen

Widely used products

 
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