Airflow pattern visualization provides a visual record of actual airflow patterns in a pharmaceutical facility. It is currently the most widely accepted method of demonstrating that airflow patterns in critical processing areas meet regulatory expectations.
Air pattern analysis (air-flow visualization with conclusions) is an expectation by regulatory bodies worldwide and an important tool for contamination control. Characterization and documentation of airflow patterns in cleanrooms, barrier systems and controlled environments.
The study visually demonstrates the movement of air within the clean room, identifying potential dead zones or areas with inadequate air exchange.
It assesses the containment efficacy of equipment, ensuring that hazardous or potent compounds are appropriately controlled and do not cross-contaminate adjacent areas.
The study identifies potential cross-contamination pathways between different processing areas, helping in the design of efficient workflow layouts.
A smoke study helps evaluate the exposure of personnel to potential contaminants, ensuring that workstations and personnel movement are in compliance with safety standards.
The study validates the clean room’s design and HVAC (heating, ventilation, and air conditioning) systems, ensuring that they meet regulatory requirements.
Furthermore, regulatory frameworks like ISO 14644-3, EU GMP Annex 1, and US FDA guidance recommend airflow visualization studies to characterize and document airflow patterns.
Airflow visualization studies ensure the proper functioning of cleanroom environments, particularly in maintaining the stringent standards required for Class A (ISO 5) classifications.
GAMP GROUP has Highly Experience Smoke Study Team of 40 Engineers to take care of 360 Degree Multiple Angle Smoke Study Requirement of the clients. We have expeeirenc of smoke study for more than 200+Filling lines .
We have more than 20+ Smoke Study systems which includes Microrite Fogger and manifold system.
Acceptance criteria for smoke studies should be explicitly stated to ensure clarity and compliance. For static conditions, the criteria might include demonstrating that unidirectional airflow patterns sweep down and/or away from exposed products, product contact packaging components, and product contact surfaces.
It is important to record all relevant data such as the date, time, personnel present, and room location at the time the smoke studies are conducted. The results should be reported in a binary fashion (Yes or No) or rated (Very Good “+++”, Good “++”, Requires Improvement “+”, Poor “-“) based on predefined acceptance criteria. This comprehensive documentation ensures that the airflow visualization studies meet all regulatory and quality standards, providing evidence that the cleanroom or barrier system operates as intended.