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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

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Metrology Specialist
Cleanroom Engineer
Quality Assurance Auditor
Instrumentation Technician
Contamination Control Expert
1
Is the cleanroom classified according to ISO 14644 standards?
2
What is the current particle count in the cleanroom?
Min: 0
Target: 100
Max: 1000
3
Is the particle counting system calibrated and functioning correctly?
4
Describe the procedures in place to ensure data integrity for monitoring systems.
5
Is there a procedure for reporting contamination events in the cleanroom?
6
What was the date of the last reported contamination incident?
7
What was the response time (in minutes) to the last contamination incident?
Min: 0
Target: 30
Max: 120
8
What control measures are in place to prevent contamination?
9
Does the air quality in the cleanroom meet the specified ISO 14644 standards?
10
What is the average airflow velocity in the cleanroom (in meters per second)?
Min: 0.1
Target: 0.45
Max: 1.5
11
When was the last air quality audit conducted?
12
Describe the monitoring equipment used for air quality measurements.
13
Is the particle monitoring system calibrated and checked at the required frequency?
14
What is the average particle size measured in the cleanroom (in micrometers)?
Min: 0.1
Target: 0.5
Max: 5
15
When was the last calibration of the particle monitoring system performed?
16
Describe the procedures for operating and maintaining the particle monitoring system.
17
Is there a documented schedule for cleaning the cleanroom?
18
When was the cleanroom last cleaned (in days ago)?
Min: 0
Target: 7
Max: 30
19
Is there a documented cleaning procedure for the cleanroom?
20
List the cleaning materials and agents used in the cleanroom.

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 of ISO 14644 Cleanroom Particle Monitoring System Audit Checklist

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