smoke study project and review

What Are Airflow Visualization Smoke Studies (AVS) ?

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.

Importance in Cleanrooms and Aseptic Facilities

01

Airflow Visualization

The study visually demonstrates the movement of air within the clean room, identifying potential dead zones or areas with inadequate air exchange.

02

Containment Assessment

It assesses the containment efficacy of equipment, ensuring that hazardous or potent compounds are appropriately controlled and do not cross-contaminate adjacent areas.

03

Cross-Contamination Prevention

The study identifies potential cross-contamination pathways between different processing areas, helping in the design of efficient workflow layouts.

04

Personnel Safety

A smoke study helps evaluate the exposure of personnel to potential contaminants, ensuring that workstations and personnel movement are in compliance with safety standards.

05

Validation of Design and HVAC Systems

The study validates the clean room’s design and HVAC (heating, ventilation, and air conditioning) systems, ensuring that they meet regulatory requirements.

multi angle smoke study

Regulatory Requirements for Airflow Visualization

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.

Types of Airflow Visualization:

  • Investigative Smoke Study
  • Engineering Smoke Study
  • Static Smoke Study
  • Dynamic Smoke Study

Airflow visualization studies ensure the proper functioning of cleanroom environments, particularly in maintaining the stringent standards required for Class A (ISO 5) classifications.

Regulatory Requirements for Airflow Visualization

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.

Smoke Study Project

Each and Every Section is important for successful Smoke Study

smoke study info multi angle smoke study

Smoke Study Review:

Defining Acceptance Criteria

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.

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