SINBRAN® filter elements for Food and Pharma applications
SINBRAN® FP filter elements can be used in applications for Food and Pharma without problems.
General speaking all objects (e.g. SINBRAN® FP filter elements) that get in contact with food must fulfill two basic criterias.
On the one hand, the materials used must be suitable as a food contact material and on the other hand, they must be manufactured in accordance with a “good manufacturing practice” (GMP). This is requested by EU 1935/2004 (EU 10/2011) and the regulations of the FDA (FDA 21CFR177.xxxx).
For manufacturing according to GMP, the regulation EU 2023/2006 applies.
SINBRAN® FP filter elements consist only of materials which have been declared harmless by both regulations. Manufacturing is carried out according to the requirements of the EU 2023/2006.
SINBRAN® FP filter elements consist only of polyethylene, PTFE, stainless steel and a silicon seal.
The SINBRAN® FP filter elements and their components are produced purely thermally or mechanically.
No manufacturing aids such as lubricants, oils, adhesives, potting compounds or solvents are used. Therefore the contamination of the product by the SINBRAN® FP filter element can be excluded.
In the case of the porous sintered body, the individual particles are solidly fused together at their contact surfaces. This reliably prevents particles from seperating from the filter element and possibly contaminating the collected product. The PTFE membrane is firmly bonded to the sintered surface and reliably separates the dust from the surface. It thus prevents the penetration of dust into the sintered body of the filter element.
The stainless steel of the flange reinforcements behaves neutral to the product.
The seals are made of food-approved silicone.
To put it simply, EC 2023/2006 states that “good manufacturing practice” is intended to ensure that items are manufactured in accordance with the relevant quality standards for the intended use. They must neither endanger human health nor cause an unacceptable change in the properties of the foods.
In order to achieve this, a number of requirements and measures are laid down in the Regulation. The SINBRAN® FP filter elements are manufactured and packed according to these requirements and measures.
At this point, it should be pointed out that SINBRAN® FP filter elements are as far as possible free from unintentional contaminations. A production under sterile conditions is not required by Regulation EC 2023/2006.
The conformity of the materials used is ensured by the fact that they are listed as safe in the relevant regulations. In addition, the materials undergoing regular migration tests performed by an independent testing institute in order to ensure their suitability beyond the general suitability of the regulations.
Production is carried out according to GMP guidelines.
A detailed specification for the inteded use is available from Sinbran GmbH.
The overall performance of the SINBRAN® FP filter elements can be certified by declarations of conformity.
Filter elements are only made of
Polyethylene, PTFE, silicone seal and stainless steel.
For antistatic elements, carbon black is embedded in the polyethlene.
Polyethylene as base material for the flanges, bottoms and tubes is listed as suitable in the Union list of EU 10/2011 under ref. No. 125. The FDA lists polyethylene in the 21CFR177.1520 as being suitable.
PTFE of the membrane is listed as suitable in the Union List of EU 10/2011 under ref. No. 281. The FDA declares PTFE in the 21CFR177.1550 as being suitable.
The silicone of the seals is evaluated as suitable in the database of the BfR under the recommendation 150 “XV.Silicone”. So that there is no concern against the use. The FDA suggests silicone in the 21CFR177.2600 as suitable.
For stainless steel, it is state of the art that it is suitable as a food contact material.
1. Proven features:
The microfine structure of the ePTFE membrane ensures filtration efficiency > 99,9 %
The PTFE surface allows low product adhesion by the antiadhesive properties
The very smooth surface allows a very quick release of the dust
2. Low pressure drop:
Double throughput possible at same pressure drop
3. Conform materials:
Only Polyethylene, PTFE and stainless steel and silicone gasket
4. Manufacturing according to GMP:
Special care in manufacturing