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ISO 14644 Cleanroom Airflow Visualization Audit Checklist

A detailed checklist for auditing airflow visualization practices in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on the assessment of air movement patterns, detection of turbulence or dead zones, and verification of proper air distribution to maintain cleanroom integrity.

ISO 14644 Cleanroom Airflow Visualization Audit Checklist
by: audit-now
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About This Checklist

The ISO 14644 Cleanroom Airflow Visualization Audit Checklist is a critical tool for evaluating and optimizing air movement patterns in pharmaceutical cleanrooms. This comprehensive checklist aligns with ISO 14644 standards, focusing on the assessment of airflow dynamics, detection of turbulence or dead zones, and verification of proper air distribution. By systematically auditing airflow visualization practices, pharmaceutical companies can enhance contamination control, optimize cleanroom performance, and ensure compliance with regulatory requirements. Regular implementation of this checklist supports the maintenance of appropriate air cleanliness levels, aids in identifying potential contamination risks, and contributes to overall product quality assurance in cleanroom environments.

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Industry

Pharmaceuticals

Standard

ISO 14644

Workspaces

Pharmaceutical Cleanroom

Occupations

Cleanroom Engineer
HVAC Specialist
Quality Assurance Auditor
Contamination Control Expert
Airflow Visualization Technician

Airflow Patterns Assessment

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1
Is contamination control adequately implemented?

Select the contamination control status.

This evaluates the effectiveness of contamination control measures in the cleanroom.
2
What were the observations during the smoke study?

Provide detailed observations from the smoke study.

Documenting observations helps in understanding airflow patterns and potential contamination pathways.
3
What is the air change rate in the cleanroom (ACH)?

Enter the air change rate in air changes per hour.

Determining the air change rate is critical for contamination control and cleanroom performance.
Min: 15
Target: 20
Max: 25
4
Is the unidirectional airflow pattern maintained in the cleanroom?

Select the compliance status.

This ensures that the airflow is directed appropriately to minimize contamination risks.
5
When is the next airflow test scheduled?

Enter the date for the next scheduled airflow test.

Scheduling regular tests is critical to ensure continued compliance and performance.
6
Does the current airflow meet ISO 14644 compliance requirements?

Select the airflow compliance status.

Compliance with ISO standards is necessary to ensure the cleanroom operates effectively.
7
What is the current particle count in the cleanroom (particles/m³)?

Enter the particle count in particles per cubic meter.

Particle count measurement is essential for assessing cleanliness levels and airflow effectiveness.
Min: 0
Target: 100
Max: 200
8
Have any airflow anomalies been observed during operations?

Describe any airflow anomalies observed.

Identifying anomalies is crucial for maintaining cleanroom standards and preventing contamination.
9
When is the next air quality assessment scheduled?

Enter the date for the next air quality assessment.

Regular assessments are necessary to maintain compliance and ensure a safe working environment.
10
Have any unusual odors been detected in the cleanroom?

Describe any odors detected in the cleanroom.

Identifying unusual odors can indicate potential contamination or equipment issues.
11
What is the current CO2 level in the cleanroom (ppm)?

Enter the CO2 level in parts per million.

Monitoring CO2 levels is important to ensure they remain within acceptable limits for cleanroom operations.
Min: 400
Target: 800
Max: 1000
12
Is the air quality within the cleanroom compliant with ISO 14644 standards?

Select the compliance status of air quality.

Ensuring air quality compliance is crucial for the safety and effectiveness of cleanroom operations.

FAQs

The checklist covers smoke study procedures, airflow pattern analysis, identification of turbulence or dead zones, verification of unidirectional flow in critical areas, assessment of air change rates, and documentation of visualization results.

Airflow visualization helps ensure that air moves as intended to sweep away particles and maintain cleanliness levels, preventing contamination and supporting the overall performance of the cleanroom.

The audit should involve cleanroom engineers, HVAC specialists, quality assurance personnel, and contamination control experts to ensure a comprehensive evaluation of airflow dynamics.

Comprehensive airflow visualization audits should be conducted annually, with additional assessments following any significant changes to the cleanroom layout, HVAC system, or equipment placement.

Identified irregularities should trigger immediate corrective actions, such as adjusting air supply systems, modifying cleanroom layout, or repositioning equipment. A follow-up visualization study should be conducted to verify the effectiveness of these changes.

Benefits

Ensures airflow patterns comply with ISO 14644 standards for cleanroom operations

Identifies potential contamination risks due to improper air movement

Optimizes cleanroom layout and equipment placement for ideal airflow

Supports energy efficiency by verifying effective air distribution

Enhances overall contamination control strategy in pharmaceutical cleanrooms