What factors should be considered when choosing FFU for a pharmaceutical clean room?
Direct answer: First clarify the cleanliness requirements of the pharmaceutical process and each area, and then check the air supply layout of the FFU, air volume and static pressure under design conditions, filter efficiency and sealing, operation control and maintenance conditions. For aseptic production areas, FFU selection should also be connected with on-site airflow verification and environmental monitoring plans. Product parameters are qualified and cannot directly replace on-site confirmation in a clean room.
Pharmaceutical cleanrooms may be used for general clean manufacturing or may involve aseptic operations where product or critical materials are exposed. The two types of scenarios have different requirements for airflow protection and verification, and you cannot choose based on the room area alone.FFU fan filter units .Specifications and quantities of
Look at the process location first, not the FFU model first
Floor plans should identify product exposure locations, equipment, personnel and material paths, and supply and return air vents. The FFU layout needs to allow key locations to obtain the designed airflow and avoid equipment or personnel activities from interfering with the air supply. The airflow direction and operating status verification of sterile pharmaceutical projects should be determined in conjunction with the applicable project requirements; EU GMP Appendix 1 lists airflow direction and visualization, air volume and speed, and regional pressure difference as content that should be considered when confirming clean rooms and clean air equipment.
Let’s look at the overall machine performance under the same working conditions
When comparing FFU, specify the specified filter, operating gear and installation resistance conditions, and check the static pressure, wind speed uniformity, power consumption and noise corresponding to the target air volume. The 'maximum air volume' and 'maximum static pressure' may come from different working points and cannot be directly combined into project design conditions.
HEPA or ULPA filters should be selected based on particle control requirements, and check resistance under design air volume, box sealing, detection methods, and replacement space. When the filter level changes, the fan operating point and the air supply volume of the whole machine should be re-confirmed. Filtration efficiency alone cannot prove that a sterile production environment meets requirements.
Finally, look at operation, maintenance and verification
Long-term operation projects need to clearly define the target air supply, control zones, communication interfaces and status feedback for production and duty modes. When multiple FFUs need to be adjusted uniformly, you can plan in advance.FFU group control system , and verify whether the control settings correspond to the actual air volume during the prototype stage.
After installation, the filtration system, actual air volume, airflow distribution and cleanliness should be checked according to technical protocols, and the corresponding operating status of the test should be clearly defined. ISO 14644-3 provides a framework for clean room performance testing methods. For projects that are subject to sterile drug requirements, clean room and equipment confirmation should also be distinguished and connected with subsequent daily environmental monitoring.
Aili Industrial's fans, motors, control systems, sheet metal and filters are all produced and developed in-house. After the pharmaceutical project determines the process cleanliness target, the whole machine can be matched around the filter resistance, fan air supply capacity, box sealing and control mode, and the configuration can be confirmed through the prototype. Specific performance, testing and delivery requirements are subject to the project technical agreement and actual working condition test results.
