REPORTREFERENCE OUTLINE

Airflow Visualization Study (AVS) Report Template

Smoke study documentation template for critical zone airflow characterization. Includes test conditions, acceptance criteria, video reference index, and critical observation log.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
EU GMP Annex 1 (2022)ISO 14644-1
DOCUMENT TYPE
Report
LAST UPDATED
August 2024
PURPOSE

A smoke-study report characterising unidirectional airflow in the critical zone under the conditions the process actually runs in — not at rest, and not with the line idle. The report is the evidence that air sweeps product-contact points cleanly while operators intervene, and its value depends entirely on whether the filmed interventions are the real worst cases. The organisation decides which interventions qualify; this template records that decision and its rationale alongside the footage.

What's Inside

✓Test conditions — equipment configuration, line speed, container format, and the at-rest and in-operation states each run represents
✓Critical intervention scenarios, each with the rationale for including it and the worst case it is intended to represent
✓Video reference index tying every clip to a timestamp, camera position, and the observation it supports
✓Airflow observations — sweep direction, stagnation, turbulence, and any reverse flow toward product-contact surfaces
✓Acceptance assessment against pre-stated criteria, written before the study rather than fitted to the footage
✓Personnel and gowning record, because an intervention filmed by an unrepresentative operator proves little
✓Conclusions, corrective actions, and the trigger conditions that would require the study to be repeated

How to Use It

1Define the at-rest and in-operation states, and state which routine and non-routine interventions each run must cover
2Set the acceptance criteria before filming — a study assessed against criteria written afterwards is not evidence
3Film every critical intervention as performed, with the gowning and technique used in production rather than a rehearsed version
4Index each clip to the observation it supports, so a reviewer can reach the footage behind any conclusion
5Assess sweep and disturbance against the stated criteria, recording turbulence and any flow toward exposed product
6Close out corrective actions and record what change would invalidate the study and require it to be repeated
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose, Scope, and Acceptance Criteria
2Equipment and Configuration Under Test
3At-Rest and In-Operation Test States
4Critical Intervention Scenarios Filmed
5Video Reference Index
6Airflow Observations and Disturbances
7Assessment Against Acceptance Criteria
8Conclusions and Corrective Actions
REGULATORY CONTEXT

EU GMP Annex 1 (2022) expects airflow visualisation demonstrating unidirectional flow in critical zones under dynamic conditions, and expects the study to sit inside the site contamination control strategy rather than beside it. ISO 14644-1 governs the classification the zone is qualified to, and USP <1116> frames how monitoring data is interpreted against it. What no authority prescribes is which interventions constitute the worst case at a given line — that determination belongs to the organisation, and this template exists to record it, its rationale, and who approved it.

MAPPED STANDARDS
EU GMP Annex 1 (2022)ISO 14644-1
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