Standard Guide for Critical Airflow Visualization

Importancia y uso:

4.1 EudraLex GMP Guidelines requires “personnel available with appropriate training and experience in microbiology, sterility assurance, and knowledge of the processes to support the design of the manufacturing activities,” therefore, an appropriate subject matter expert should have direct oversight of airflow studies including management review of any airflow deficiencies, and determination where redesign of manipulations or equipment is needed with appropriate justifications. Demonstration of proper airflow over critical areas in aseptic manufacturing is required per EudraLex GMP Guidelines and requires that the maintenance (of unidirectional airflow) should be demonstrated and qualified. The FDA Guidance for Industry (2004) recommends smoke studies as a tool for airflow qualification.

4.2 The visualization of airflow is subjective, and it is not possible to eliminate all turbulence in dynamic (in operation) cleanrooms. The focus of the smoke study is to show that airflow is in control and turbulence is minimized. Airflow studies are used to demonstrate that the critical zone is protected. They are also useful to determine EM sampling locations and to confirm the appropriateness of planned interventions.

4.3 Unidirectional HEPA-filtered airflow is intended to minimize the risk of microbial and particulate contamination by ensuring that only first air washes over the critical zone/area. Appropriate placement of air returns, intentional placement of equipment or materials, and purposeful, slow movements supports maintenance of the classified space. In operation smoke studies provide information related to the contamination control effectiveness of the clean air system in conjunction with the operations being performed. This can be useful in optimizing operator positions and movement in respect to airflow. Conclusions from the study may ultimately require reconfiguration of the critical area, or supporting area, or both, as applicable (for example equipment or airflow devices) to resolve deficiencies that cannot be otherwise rectified.

4.4 Qualification of critical aseptic processing areas should include an airflow visualization study to assure that unidirectional airflow exists where product may be exposed and that appropriate air returns are present and operational to prevent eddies or turbulence, or both.

4.5 The approach to airflow visualization may vary depending on the lifecycle stage of the process; for example, computational fluid dynamic modeling may be appropriate during the design phase of a new aseptic zone, while a smoke study is required for existing static or dynamic airflow studies.

4.6 Airflow patterns during the study are captured by digital media device (for example, a video camera).

Subcomité:

E55.06

Volúmen:

14.01

Número ICS:

13.040.01 (Air quality in general)

Palabras clave:

airflow; aseptic; smoke study; unidirectional;