FDA approved filter solutions

No chance for contaminants

Conical air filter element with open pleats at the bottom
Dusty air is everywhere – the reality behind this saying often causes headaches for manufacturers and producers of food and beverage, pharmaceutical and chemical products. With its filter solutions for these sectors, Mahle provides the perfect remedy.

Author Denis Ruf Head of Market Segment Factory Equipment EMEA, Mahle

When it comes to the production, handling and selling of food and beverages, water, animal feed, cosmetics, medical and chemical products, there are numerous regulations. Within the EU, companies are required to comply with EC 1935/2004 on food contact materials as well as (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food. EC 1935/2004 includes, for example, the identification and certification of food contact material. Additionally, equipment and component suppliers must ensure total traceability of a material or product throughout all its production, processing and sales steps. Significantly more important for manufacturers is Regulation (EU) No. 10/2011, which regulates plastic materials and articles intended to come into contact with food. Without this declaration of conformity, sales of components to customers within the EU in the pharma-ceutical or food and beverage industries are no longer permitted. Equivalent FDA regulations exist in the USA.
Mahle has adapted to this situation. All components of its special filter elements manufactured for the chemical, pharmaceutical and food and beverage industries are approved by the FDA and (EU) No. 10/2011, including air filter elements with stainless steel end plates and filter material, star-pleated, cylindrical or conical filter elements, filters with open pleats at the bottom or multijet cleaning units. Furthermore, special air filter elements in a variety of sizes with dead space-free sealing systems are also available. The sealing systems are made from a silicone which has been tested and approved by an accredited laboratory. The seals conform to the thresholds of (EU) No. 10/2011 and the FDA. Since the complete end plate is covered by the seals, any product build-up is prevented. The removable seals are washable and exchangeable, and they also enable the filter elements to be inserted horizontally.
These filter elements can be used, for example, in top silo filters, bunker or mixer filters and pneumatic conveyors as well as in vacuum systems for packaging equipment. They are suitable for all kinds of dust particles, including sugar, flour, milk powder, flavourings and cocoa. Alongside its polyester-based filter materials compliant with FDA and (EU) No. 10/2011), Mahle also offers special materials with increased chemical resistance upon request, which likewise conform to the regulations. The Ti 2011 filter material was developed specifically for filtering fine, electrically chargeable and flammable dusts. This combination of an electrically conductive filter material and a laminated PTFE membrane features a pure white surface, in contrast to other electrically conductive materials. It therefore meets customer requirements in potentially explosive areas in pharmaceutical, chemical or food and beverage applications, where sometimes only light-coloured, electrically conductive components may be employed. The electrically charged particles transfer their charge to the conductive polyester-bicomponent fibre mat through the PTFE membrane. Ti 2011 is characterised by its high strength and loading capacity, and demonstrates very good cleaning behaviour. The material has been approved by the FDA under 21 CFR Ch. I §177.1550 as well as in accordance with the European regulation (EU) No. 10/2011. Its electrostatic behaviour is certified according to DIN EN 54345 Part 5.

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