How to choose FFU filter for biomedical clean environment?
Direct answer: First clarify the process area and pollution control requirements, and then select a HEPA or ULPA filter that meets the project's filtration efficiency and testing requirements. After determining the filter, check the resistance at the design air volume, the seal with the FFU box, on-site replacement conditions, and whether the entire machine can maintain the target air supply. Filtration level alone cannot represent the actual effectiveness of a clean environment.
Biopharmaceutical projects may include different scenarios such as general clean production, product exposure operations, and aseptic processing. Filter requirements should be determined individually by process and project applicable specifications, and the same configuration cannot be used to cover all areas. For items that are applicable to the production of sterile pharmaceutical products, Appendix 1 of the EU GMP lists leakage and integrity testing of the post-installation filtration system, air volume, speed and air flow direction as items that should be considered when confirming clean rooms and clean air equipment.
Three selection questions, do not reverse the order
What does the process need to control?
Identify whether product or critical materials are exposed, target cleanliness levels, particle control requirements, as well as filter efficiency and detection methods. CompareHEPA and ULPA air filters should be based on these requirements. When choosing a higher filtration level, you must also confirm the corresponding air volume and maintenance conditions.
What is the resistance at the design air volume?
Filter resistance should be compared under the conditions indicating the test air volume. loadAfter the FFU fan filter unit , the resistance will affect the fan working point; if you useWhen using ULPA filters or changing filter specifications, the static pressure, power consumption and overall air supply volume under the target air volume should be rechecked.
Can it be sealed, tested and replaced after installation?
The filter frame and sealing method must match the FFU box, and there should be space for leak detection, maintenance and replacement on site. Just because the filter passes the test alone does not mean that the installed filtration system has passed the verification.
Acceptance depends on the combined results of the filter and the clean area
During the prototype stage, the filter model, installation seal, initial resistance and air volume at the FFU design level can be confirmed. For sterile pharmaceutical projects, equipment and clean room qualification should be distinguished from daily operating environment monitoring;
Aili Industrial's filters, fans, motors, sheet metal and control systems are all produced and developed in-house. After determining the filtration requirements for a biomedical project, the filter resistance, fan supply capacity, box sealing and operating gear can be matched simultaneously, and then the configuration can be confirmed through prototype and complete machine testing. The specific filter model, FFU performance and on-site verification results are subject to the project technical agreement and actual working conditions testing.
Before technical communication, it is recommended to prepare: process area and cleanliness requirements, target air volume, filter efficiency and testing requirements, ceiling or equipment installation drawings, maintenance directions, and on-site verification conditions. After the information is clear, it will be easier to select the filter type to correspond to the performance of the whole machine.
