CASE STUDY

Ingress and Egress Airflow Visualization Study for a Cell Therapy GMP Facility

SOKOL GxP Services

Airflow Visualization Study

Development and execution of a site-specific AFV procedure aligned with EU GMP Annex 1 (2022) to verify airflow directionality, pressure cascade performance, and contamination control strategy compliance.

18 Сlassified interfaces tested

6 Airlocks and pass-throughs evaluated

160+

Page Annex 1–aligned report delivered

INDUSTRY

Cell Therapy Manufacturing

FACILITY CLASSIFICATION

ISO 7 and ISO 8

REGULATORY FRAMEWORK

EU GMP Annex 1 (2022)

STUDY TYPE

At-rest Ingress/Egress AFV

METHODOLOGY

Neutrally Buoyant Tracers (NBT)

OUTCOME

Inspection-ready documentation and CCS support

PROJECT OVERVIEW

SOKOL GxP Services was engaged by a cell therapy manufacturing client to design and execute an Ingress/Egress Airflow Visualization (AFV) study in support of EU GMP Annex 1 (2022) compliance and the site’s Contamination Control Strategy (CCS) for a newly constructed GMP facility.

As part of this engagement, SOKOL developed a new site-specific AFV procedure aligned with the updated Annex 1 requirements. The procedure replaced legacy practices and introduced a modern, risk-based approach to airflow visualization, consistent with current regulatory expectations and industry best practices.

The facility included a main ISO 8 manufacturing suite, an ISO 7 support suite, personnel and material airlocks, and pass-throughs connecting ISO 7 and ISO 8 areas. The objective of the study was to verify and document airflow directionality and pressure cascade performance, providing objective evidence that airflow is consistently maintained from higher-classified areas to lower-classified areas and that reverse airflow from lower-classified areas into higher-classified areas does not occur under defined static operating conditions.

SCOPE AND REGULATORY CONTEXT

The at-rest AFV study was performed in alignment with EU GMP Annex 1 (2022) contamination control and airflow direction requirements, the site’s updated Contamination Control Strategy, HVAC design intent, and approved facility layouts. Regulatory expectations for objective, visual evidence supporting contamination control were incorporated into the study design and documentation approach.

The newly developed AFV procedure established a repeatable and compliant methodology for both initial qualification and future requalification activities.

SOKOL’S APPROACH

Procedure, Protocol, and Methodology Development

SOKOL authored a site-specific AFV procedure defining methodology, acceptance criteria, test conditions, documentation requirements, data retention, and deviation management in accordance with Annex 1 expectations. The procedure specified the use of Neutrally Buoyant Tracers for airflow visualization and clearly defined at-rest test conditions.

Based on the procedure, SOKOL developed and executed approved AFV protocols covering ISO 7 to ISO 8 room interfaces, personnel and material airlocks, and pass-throughs under at-rest conditions representative of normal facility operation prior to occupancy.

Study Execution

AFV activities were executed using an NBT fogging system to visualize airflow patterns at room boundaries, airlocks, and pass-throughs. Execution was coordinated with engineering, validation, quality, and operations to ensure alignment with facility status and HVAC operating parameters.

Documentation and Evidence Generation

All airflow patterns were video recorded and evaluated against protocol-defined acceptance criteria. SOKOL compiled the results into a comprehensive AFV summary report providing objective evidence of airflow directionality, confirmation of pressure cascade effectiveness, and traceable documentation suitable for regulatory inspection and audit review.

Results and Outcomes

The study demonstrated consistent airflow directionality from higher-classified areas to lower-classified areas under at-rest conditions. HVAC system performance was confirmed to support contamination control objectives at classified area interfaces. The implementation of a modern AFV methodology aligned with Annex 1 (2022) replaced legacy LN₂ fogging practices and improved the site’s regulatory readiness. Inspection-ready documentation was delivered to support CCS implementation and qualification records.

Value To The Client

The engagement reduced regulatory risk through Annex 1–aligned AFV procedures, protocols, and reporting. It strengthened the site’s CCS with objective visual evidence and established a standardized, repeatable AFV framework for future qualification and requalification activities. The modernized approach improved inspection readiness and demonstrated proactive compliance with evolving EU GMP expectations.

Topics Covered

EU GMP Annex 1 (2022) compliance

Contamination Control Strategy support

Airflow Visualization of ingress/egress thresholds under at-rest conditions

Use of Neutrally Buoyant Tracers

Pressure cascade verification

Protocol-driven qualification execution

Video-based evidence generation

Cross-functional coordination

WHY CHOOSE SOKOL

SOKOL GxP Services specializes in Annex 1 implementation, advanced therapy manufacturing facilities, and risk-based qualification strategies.

By combining regulatory expertise with practical execution, SOKOL delivers airflow visualization studies that are compliant, defensible, repeatable, and inspection-ready.

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