Vacuum-compatible stainless steel push-in fittings

Andreas Mühlbauer,

Safe and clean in the cleanroom

When processing hormones in the pharmaceutical industry, no components of the product may escape into the environment. This is why, for example, the mixing process takes place in a vacuum clean room. Reliable compressed air connections are of great importance to ensure the tightness and therefore the safety of the entire system.

The mixer is housed in a clean room. © Lödige Brothers

The Paderborn-based company Gebrüder Lödige Maschinenbau specializes in the production and development of application-specific process technology and is an expert in basic process engineering operations such as the mixing, drying and granulation of bulk materials.

Lödige supplies customized mixers, dryers and reactors to companies from the life science industry to the chemical and building materials industries. The plowshare mixers achieve the highest mixing quality with short mixing times and excellent product protection. They work according to the spinning and whirling process developed by Lödige. The mix is always completely caught by the blades, so that there are no zones with little movement. This allows various process steps to be combined, for example mixing, granulating and drying.

Ploughshare mixers are used in almost all industries for a wide variety of mixing tasks. They consist of a horizontal cylindrical drum in which the centrally mounted shaft, equipped with ploughshare blades, moves the product into a mechanically generated fluidized bed. Due to the intensive mixing and the resulting frequent contact of the particles with the optionally heatable apparatus wall, a high heat transfer can be achieved without local overheating. The intensity of the particle movement increases during drying as the moisture content and viscosity decrease.

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When nothing is allowed to escape

Lödige used simple straight plug-in connections with release sleeves in three sizes in the customer project. © Eisele

Lödige machines are specific special machines based on various basic types such as the GMP (Good Manufacturing Practice) ploughshare mixer for pharmaceutical and food applications, a dynamic compulsory mixer. In a system for the pharmaceutical industry in which a hormone preparation for veterinary medicine is to be processed, absolutely safe containment is important to prevent hormones from being released into the environment. Even minimal doses of these can cause strong reactions, even in humans. In addition, absolutely no substances from the environment may enter the cleanroom.

In this application, batch mixing, granulation and drying take place in one and the same machine, whereby the process area is located in the clean room and the connections and operating elements are accessible from an external technical area. The ploughshare mixer has a temperature control jacket that ensures gentle heating and drying of the product in the process. In order to achieve faster drying at a low temperature, a vacuum pump generates negative pressure in the process chamber. This not only protects the temperature-sensitive product, but also supports safe containment, as no material can escape under negative pressure. As the machine is used in an American pharmaceutical company, the regulations of the Food and Drug Administration (FDA) must also be met in addition to the GMP requirements mentioned above.

Top priority for absolute tightness

As the connections need to be particularly tight and secure, Lödige used stainless steel connections from Eisele Pneumatics ' 17A range for various compressed air connections required to operate the paddle dryer. The easy-to-clean design and corrosion resistance of the stainless steel connections also played a role. The plug-in connections and the associated hoses are permanently installed on the system and only need to be removed for repairs or inspections. Due to the design of the connections, however, this is possible without any problems. Three different connection types are used. Stainless steel was chosen to create optimum hygienic conditions and to enable easy cleaning. The connections come into contact with nitrogen and air as operating media. Neither medium requires any particular corrosion resistance, but in a sterile application they must not be contaminated by the materials or contaminated with particles.

The Inoxline connections of the 17A range are optionally available with FDA-compliant seals. © Eisele

The stainless steel connections are used at room temperature and a pressure level of up to six bar in the application. As no product parts are allowed to escape into the environment, it was crucial that the components were reliably leak-free. The special sealing technology of the 17A range with two FKM (Viton) seals in the collet was therefore a key decision factor. These stainless steel connections can withstand internal gas pressures of up to 24 bar, but are also suitable for negative pressures of up to -0.95 bar. For liquids, pressures of up to 100 bar are even possible, depending on the medium and connection sizes used. Although many push-in fittings are designed for high pressures, they are not vacuum-proof. The release sleeve of the push-fit connections with internal collet enables the hose to be fitted and removed quickly. The second seal on the connections enables higher working pressures and provides additional protection against dirt entering the system. A chambered O-ring on the side of the screw-in piece ensures the necessary tightness between the machine and the connection.

The good workmanship as well as the high reliability and safety of the components were the decisive and convincing features of the Eisele plug-in connections and not only convinced the client, who had expressly requested the use of Eisele components in his system. The experts at Lödige were also highly satisfied with the components: "Eisele was exactly the right choice for this hygiene- and safety-critical application, because the tightness and processing quality of the plug-in connections offer a decisive safety advantage," explains Reiner Lemperle, Sales Manager at Lödige.

Thomas Maier, Managing Director, Eisele Pneumatics / am

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