How to cooperate with cleanliness verification when using FFU in sterile production areas?

Direct answer: First confirm that the FFU and filter are installed and operating according to project requirements, and then verify the filter seal, air supply volume, wind speed and air flow direction, regional pressure difference and cleanliness on site. The verification plan should also cover the agreed production operation status and be connected with subsequent environmental monitoring. The FFU factory test is qualified and cannot directly replace the on-site verification of the sterile production area.

Sterile manufacturing areas are concerned not only with the number of particles in the air, but also with airflow protection and microbial contamination control at critical locations. For items that apply to the sterile production requirements of pharmaceuticals, EU GMP Appendix 1 distinguishes the confirmation of clean rooms and clean air equipment from daily operating environment monitoring, and lists related confirmation items such as filtration system integrity, air volume and speed, pressure difference, air flow direction and visualization, and microbial contamination.

First make the FFU configuration consistent with the verification scheme

Installed on siteThe FFU fan filter unit should be consistent with the fan, motor, box, control gear andHEPA/ULPA filter configuration is consistent. After the filter model or operating gear is changed, the original air volume data may not represent the on-site working conditions and should be rechecked.

Before verification, it is necessary to clarify the key process locations, personnel and equipment layout, FFU air supply direction and return air path. Measuring only the wind speed at the outlet of a single FFU cannot tell whether the key operating positions are getting the expected airflow protection.

On-site verification is carried out layer by layer according to 'equipment, air flow, area'

These projects should adopt testing methods suitable for the production process and project level, and clearly define the measuring points, operating status and judgment conditions. ISO 14644-3 provides a framework of performance testing methods for clean rooms and clean areas; specific sterile production verification and monitoring requirements should be based on the specifications and technical documents applicable to the project.

After passing the verification, continuous monitoring is still required.

Clean area confirmation is used to prove that the equipment and environment meet the design under agreed conditions; operating environment monitoring is used to observe whether the environment is continuously controlled during the production process. EU GMP Appendix 1 clearly distinguishes between these two types of work and requires monitoring locations, frequencies and methods to be determined based on process risks. Requirements related to aseptic production

After filter replacement, FFU inspection, control gear adjustment, or production equipment layout change, the need to retest airflow and cleanliness should be evaluated according to the project change procedure. Otherwise, the original verification results may not represent the new operating status.

How does Aili Industry cooperate with project confirmation?

Aili Industrial's fans, motors, control systems, sheet metal and filters are all self-produced and self-developed, and can match the FFU complete machine around the target air volume, filtration requirements, installation space and control mode of the aseptic production area. During the prototype stage, the filter installation, air supply and control functions of each gear can be confirmed; after batch installation, corresponding configuration and test data will be provided according to the project verification plan.

The specific performance, on-site verification results and delivery requirements of Aili Industrial FFU should be based on the project technical agreement and actual working condition test data. Whether the aseptic production area reaches the required clean state will still be judged by complete on-site confirmation and operational monitoring results.