Quality aspects in the manufacture of filters for the chemical and pharmaceutical industries

The philosophy and quality goals of KÖGEL FILTER are to manufacture and deliver high-quality filter products in a sustainable manner. The production, development and quality management departments have special tasks.

In order to meet quality standards in the pharmaceutical industry in particular, we have made extensive investments in the latest production technology.

Since April 2020, all our filter products have been manufactured under ISO 7 clean room conditions.

State-of-the-art laser and ultrasonic technology guarantees the required high level of accuracy and cut edge sealing of our filters. In addition, we have a special, partly self-developed welding technology that allows us to replace many sewing processes. All of our developments and efforts are aimed at producing the filter without seam perforations as far as possible. We have already succeeded in doing this in many filter applications.

The cleanliness of our products is a central issue in our quality management. All conceivable measures are taken to avoid cross-contamination of our products. Our extensive QA system according to DIN EN 9001: 2015 regulates this in the corresponding process and work instructions. For our filters in the pharmaceutical sector, we only use EU and FDA compliant filter media and semi-finished products. Our QA documentation allows the complete traceability of all of our raw materials that we use for production. With every delivery we create the corresponding declarations of conformity according to EU and FDA.

Use of the latest production technology:

•    Ultrasonic cutting machine and laser for cutting
•    hot air welding technique
•    hot wedge welding technology

The filter cloths are manufactured in our ISO 7 clean room.

Use of EU and FDA compliant filter media and semi-finished products. Compliance with EU Directive 1935/2004 and Plastics Directive 10/2011; Materials tested for toxicity and migration according to EN1186;