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ISO 14644 Cleanroom Particle Monitoring System Audit Checklist

A comprehensive checklist for auditing particle monitoring systems in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on equipment installation, calibration, data collection, and system maintenance to maintain accurate cleanroom classification and contamination control.

ISO 14644 Cleanroom Particle Monitoring System Audit Checklist
by: audit-now
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About This Checklist

The ISO 14644 Cleanroom Particle Monitoring System Audit Checklist is a crucial tool for ensuring the accuracy and reliability of particle monitoring in pharmaceutical cleanrooms. This comprehensive checklist aligns with ISO 14644 standards, focusing on the installation, operation, maintenance, and calibration of particle counting systems. By systematically evaluating these monitoring systems, pharmaceutical companies can maintain accurate cleanroom classification, detect contamination events promptly, and ensure compliance with regulatory requirements. Regular implementation of this checklist enhances the integrity of cleanroom monitoring data, supports informed decision-making, and contributes to overall quality assurance in pharmaceutical manufacturing.

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Industry

Pharmaceuticals

Standard

ISO 14644

Workspaces

Pharmaceutical Cleanroom

Occupations

Metrology Specialist
Cleanroom Engineer
Quality Assurance Auditor
Instrumentation Technician
Contamination Control Expert

Particle Monitoring and Data Integrity

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1
Describe the procedures in place to ensure data integrity for monitoring systems.

Provide a detailed description of the data integrity procedures.

To assess the robustness of data handling and integrity measures.
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2
Is the particle counting system calibrated and functioning correctly?

Select the calibration status of the particle counting equipment.

To ensure accurate particle monitoring and compliance with regulations.
3
What is the current particle count in the cleanroom?

Enter the particle count measured in the cleanroom.

To monitor the air quality and ensure it meets specified limits.
Min: 0
Target: 100
Max: 1000
4
Is the cleanroom classified according to ISO 14644 standards?

Select the appropriate classification compliance status.

To ensure that the cleanroom meets necessary standards for particle cleanliness.
5
What control measures are in place to prevent contamination?

Provide a detailed description of the contamination control measures.

To assess the effectiveness of contamination control strategies.
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6
What was the response time (in minutes) to the last contamination incident?

Enter the response time in minutes.

To evaluate the efficiency of the response to contamination events.
Min: 0
Target: 30
Max: 120
7
What was the date of the last reported contamination incident?

Enter the date of the last contamination incident.

To track the frequency and management of contamination events.
8
Is there a procedure for reporting contamination events in the cleanroom?

Select the status of the contamination reporting procedure.

To ensure that contamination incidents are promptly reported and addressed.
9
Describe the monitoring equipment used for air quality measurements.

Provide a detailed description of the air quality monitoring equipment.

To assess the suitability and calibration of equipment used for monitoring.
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10
When was the last air quality audit conducted?

Enter the date of the last air quality audit.

To ensure regular monitoring and compliance with air quality standards.
11
What is the average airflow velocity in the cleanroom (in meters per second)?

Enter the average airflow velocity.

To ensure that airflow is sufficient to maintain cleanroom standards.
Min: 0.1
Target: 0.45
Max: 1.5
12
Does the air quality in the cleanroom meet the specified ISO 14644 standards?

Select the compliance status of the air quality.

To verify that air quality is within acceptable limits for pharmaceutical operations.
13
Describe the procedures for operating and maintaining the particle monitoring system.

Provide a detailed description of the operational procedures.

To evaluate the thoroughness of operational procedures related to the monitoring system.
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14
When was the last calibration of the particle monitoring system performed?

Enter the date of the last calibration.

To track the maintenance of the monitoring system and ensure accuracy.
15
What is the average particle size measured in the cleanroom (in micrometers)?

Enter the average particle size in micrometers.

To evaluate the effectiveness of the particle monitoring system in detecting relevant particle sizes.
Min: 0.1
Target: 0.5
Max: 5
16
Is the particle monitoring system calibrated and checked at the required frequency?

Select the monitoring frequency compliance status.

To ensure that monitoring systems are functioning optimally and meet regulatory requirements.
17
List the cleaning materials and agents used in the cleanroom.

Provide a detailed list of cleaning materials and agents.

To assess the appropriateness and compliance of cleaning materials with cleanroom standards.
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18
Is there a documented cleaning procedure for the cleanroom?

Enter the status of the cleaning procedure documentation.

To ensure that cleaning is performed consistently and effectively according to established procedures.
19
When was the cleanroom last cleaned (in days ago)?

Enter the number of days since the last cleaning.

To monitor the frequency of cleaning activities in the cleanroom.
Min: 0
Target: 7
Max: 30
20
Is there a documented schedule for cleaning the cleanroom?

Select the status of the cleaning schedule.

To ensure that the cleanroom is maintained according to a consistent and regulatory-compliant schedule.

FAQs

The checklist covers sensor placement and installation, calibration procedures, data collection and reporting systems, alarm settings, maintenance schedules, and operator training for particle monitoring equipment.

By ensuring accurate and reliable particle monitoring, the checklist helps verify that cleanrooms consistently meet their designated ISO classification levels and detect any deviations promptly.

The audit should involve metrology specialists, cleanroom engineers, quality assurance personnel, and equipment maintenance technicians to ensure a comprehensive evaluation of all aspects of the monitoring system.

Comprehensive audits should be conducted bi-annually, with more frequent checks on critical components such as calibration status and data integrity. Daily system checks should also be part of routine operations.

Discrepancies should trigger immediate investigation, including recalibration of equipment, verification of sensor placement, and review of data collection processes. If systemic issues are found, a complete overhaul of the monitoring system may be necessary.

Benefits

Ensures particle monitoring systems comply with ISO 14644 standards for cleanroom classification

Improves reliability and accuracy of cleanroom air quality data

Facilitates early detection of contamination events or cleanroom performance issues

Supports consistent calibration and maintenance of particle monitoring equipment

Enhances regulatory compliance and data integrity in cleanroom operations