Regulatory compliance of process filtration systems

For many industrial processes, such as the production of food, cosmetics or pharmaceutical products, filtration is an essential part of the manufacturing process. Process filtration systems play a central role in preventing contamination and ensuring optimal product quality. Filters in food and beverage production are considered food contact materials (FCM) as soon as they come into contact with the product or with media that directly contact the product (e.g. compressed air, water, steam) and are subject to strict legal requirements. The materials used for these process filters must be food grade and must not leach any substances into the surrounding food. In addition, they need to withstand high temperatures and chemical exposure to enable effective cleaning and sterilization (cleaning-in-place or sterilization-in-place). Materials such as stainless steel and specific plastics that are suitable for these applications are therefore subject to defined regulatory requirements and testing procedures. 

These legal requirements are based on the Framework Regulation (EC) 1935/2004, which applies to all materials and substances intended to come into contact with food. Among other things, it ensures that the FCMs do not release any potentially hazardous ingredients into the food and do not cause any change in the organoleptic properties or composition of the food. If the filters are manufactured from plastic, as is the case with many membrane or depth filters, the specific amendment to the Framework Regulation, Regulation (EU) 10/2011, applies. This regulation ensures that the plastic materials are suitable for food contact. Compliance is verified through, among other measures, migration testing of specific chemicals, the assessment of heavy metal release into food simulants, and the evaluation of extractable substances. 

In general, filter manufacturers have the corresponding certificates or declarations of conformity (DOC) in accordance with (EC) 1935/2004 or (EU) 10/2011 available for their products or can issue them. If filters for food contact are used outside the EU, the local regulations apply. For example, in the USA, the requirements for FCMs are laid down in the Code of Federal Regulations (CFR Title 21),  which differs from the EU regulations. Therefore, the two regulatory frameworks are not interchangeable. Compliance with CFR Title 21 cannot substitute compliance with Regulation (EC) 1935/2004 and vice versa. 

In addition to the filter materials and their manufacture, the associated documentation also plays a critical role. Performance certificates such as filtration efficiency, retention rates, or pore size determine the possible fields of application for a filter system or the suitability for safeguarding critical control points within the framework of a HACCP or HARCP system. Validation documents are likewise a vital part of the overall documentation package. For sterile filters, documented microbial retention and steam resistance during sterilization are critical decision‑making criteria. Manufacturer‑supplied documentation on maintenance, cleaning, and disinfection represents added value for customers. These instructions might significantly extend the service time of the filters and thus noticeably reduce operating costs.

Another critical aspect is the compliance of filter systems with EU‑wide and national product‑safety standards. For example, EU food producers must implement the HACCP concept (Hazard Analysis & Critical Control Points) as required by Regulation (EC) 852/2004. This concept ensures that food is safe by analyzing and controlling all relevant process steps and critical control points. If filters are used to ensure sterile filtration, they must be appropriately qualified for sterile use and validated within the process. 
 

The guidelines and concepts of EHEDG (European Hygienic Engineering & Design Group) go in the same direction. Individual areas of beverage and food production including wine, beer and non-alcoholic beverage applcations, are classified into different hygiene levels, and the filtration systems are adapted accordingly. According to EHEDG Guideline 47, an area with a high hygiene risk (Zone H) requires a separation efficiency of at least 99.995%. for the final air filter. Another relevant point is testing according to the International Food Standard (IFS).  The integration of the filters into the HACCP concept, including specification and suitability, supplier management, installation, maintenance, and monitoring of integrity, is checked. 

Regulatory compliance in filtration systems is central to maintaining product safety, process consistency, and consumer protection. As regulatory frameworks continue to develop, manufacturers and food producers must regularly review how these requirements are interpreted and applied within their operations. A properly engineered and fully compliant filtration system supports reliable performance, protects product quality, and reinforces confidence throughout the supply chain.

At Atlas Copco, we work closely with customers to design filtration solutions that meet current regulatory expectations while supporting long-term operational stability. Contact our experts to discuss your application and receive expert guidance on selecting the right filtration system for your process.