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Tablet mit einer CFD-Simulation
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CFD simulations

Ensure isolator design compliance with airflow simulations

Service area
Virtual simulation
Lifecycle
Design & Qualification Operation Modernization
CFD simulations at a glance

The most realistic isolator airflow visualization for Annex 1 compliance

  • Transparent airflow visualization

    Simulation and representation of air flow profiles in isolators

  • Early risk detection

    Identification of potential turbulence, dead zones, and recirculation already at the design stage

  • Pressure cascades under control

    Modeling and assurance of stable pressure differentials between isolator zones

  • Informed design decisions

    Data-driven optimization of isolator layout and airflow management

  • Reduced design iterations

    Minimization of costly design modifications through simulations prior to construction

  • Regulatory assurance

    Traceable simulation results to support audits and inspections

  • Validation in accordance with Annex 1

    Demonstration of unidirectional airflow and homogeneous velocity distribution

  • Strengthening the CCS

    Quantitative basis for the Contamination Control Strategy (CCS) in accordance with EU-GMP Annex 1

Application

Verified quality and compliance of isolator designs

  • For visualization and validation of airflow

    Simulation and visualization of laminar airflow patterns within the isolator. Verification of unidirectional airflow and air velocity distribution in accordance with Annex 1. Identification of potential turbulence or recirculation zones that could compromise aseptic conditions.

  • For isolator design optimization

    Guidance of equipment layout and airflow design to develop isolator solutions that perform as intended from the outset, reducing the need for costly design updates. Evidence-based justification to support regulatory inspections and audits.

CFD Flow Simulaton
Process

Your path to optimal isolator design

  • 1

    Project initiation

    Definition of objectives and collection of project-specific data.

  • 2

    Geometry and grid generation

    Preparation of a detailed geometric model based on multiple data sources. Development of a high-resolution computational grid.

  • 3

    Definition of boundary conditions

    Specification of inlet/outlet conditions and wall behavior. Modeling air as an ideal gas using an appropriate turbulence model. Precise setup of fluid parameters, temperature, and pressure.

  • 4

    Numerical solution

    Iterative computation using specialized software (e.g., ANSYS CFX). Ensuring convergence by reducing residuals by at least three orders of magnitude.

  • 5

    Evaluation and visualization

    Visualization of airflow using streamlines and pressure fields. Identification of critical zones to support targeted risk assessment.

Service highlights

Identify risks before they arise

  • Targeted risk minimization

    CFD simulations make critical flow phenomena visible before they occur in the actual system. Turbulence, recirculation zones, or areas with insufficient air velocity are identified and evaluated at an early stage.

  • Validated airflow

    Unidirectional airflow and stable pressure cascades are demonstrated and documented in accordance with the requirements of EU-GMP Annex 1. The results provide a robust basis for qualification, audits, and regulatory inspections.

  • Support of the CCS

    Data-driven decision-making within the Contamination Control Strategy (CCS) regarding airflow, pressure, and facility layout. Strengthening of the overarching risk management documentation required under Annex 1.

CFD Flow Data

Technical specifications

  • CFD simulations package

    Airflow visualization, Decontamination cycle homogenization, Detailed CFD studies, Particle tracking

  • Simulation scope

    Calculation of turbulent, isothermal, compressible airflow

  • Considered factors

    Ideal gas properties and steady-state system components

  • Data provision

    Provision of all visualizations, images, and diagrams

  • Documentation

    Detailed CFD Study report

FAQs

  • A numerical simulation of airflow used to visualize air velocity and pressure.

  • Through converged solutions using validated models, with residuals reduced by at least three orders of magnitude.

  • This ensures reliable removal of particles and prevents their deposition on surfaces, for example in vial transport areas.

  • They highlight critical airflow zones and enable targeted improvements to system layout and design.

  • They provide verifiable evidence of airflow compliance and can be used in regulatory inspections and documentation.

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