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ISO 14644 Cleanroom Classification Audit Checklist

A comprehensive checklist for auditing pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on air cleanliness, contamination control, and cleanroom classification requirements.

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

The ISO 14644 Cleanroom Classification Audit Checklist is an essential tool for maintaining the highest standards of cleanliness and contamination control in pharmaceutical cleanrooms. This comprehensive checklist ensures compliance with ISO 14644 standards, addressing critical aspects such as air cleanliness, airflow patterns, and particle concentration limits. By systematically evaluating cleanroom conditions, this checklist helps pharmaceutical companies mitigate risks, enhance product quality, and maintain regulatory compliance. Regular use of this checklist can significantly improve cleanroom performance, reduce contamination incidents, and streamline quality assurance processes.

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Industry

Pharmaceuticals

Standard

ISO 14644

Workspaces

Pharmaceutical Cleanroom

Occupations

Cleanroom Technician
Quality Assurance Specialist
Pharmaceutical Engineer
Contamination Control Specialist
Regulatory Compliance Officer

Cleanroom Classification and Contamination Control

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1
Are personnel wearing the required personal protective equipment (PPE)?

Indicate if PPE is being worn.

To confirm that staff are adhering to safety protocols within the cleanroom.
2
Are contamination control procedures documented and being followed?

Select the status of the procedures.

To ensure that proper protocols are in place for maintaining cleanroom integrity.
3
What is the air particle concentration measured in the cleanroom?

Enter the particle count in particles per cubic meter.

To verify that particle counts are within acceptable limits for cleanroom classification.
Min: 0
Target: 100
Max: 1000
4
Is the cleanroom compliant with the required ISO 14644 classification?

Select compliance status.

To ensure regulatory compliance and proper classification of cleanroom environments.
5
Is all monitoring equipment calibrated and functioning correctly?

Indicate if monitoring equipment is calibrated.

To ensure that all equipment used for environmental monitoring is accurate and compliant with standards.
6
Is the filter integrity testing up to date and compliant?

Select the status of the filter integrity testing.

To confirm that air filters are functioning properly and are compliant with cleanroom standards.
7
What is the measured airflow velocity in the cleanroom?

Enter airflow velocity in meters per second.

To verify that airflow velocity aligns with the requirements for effective contamination control in cleanrooms.
Min: 0
Target: 0.45
Max: 1.5
8
Please provide the latest temperature and humidity records from the cleanroom environment.

Enter the temperature and humidity records in detail.

To ensure that temperature and humidity levels are maintained within specified limits for cleanroom operations.
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9
Please provide a summary of the training materials used for cleanroom training.

Enter a summary of the training materials.

To ensure that training materials are updated and relevant to current cleanroom standards.
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10
How many training sessions have been conducted in the last year?

Enter the total number of training sessions.

To assess the adequacy of training efforts over the past year.
Min: 0
Target: 6
Max: 100
11
When was the last training session conducted for cleanroom personnel?

Enter the date of the last training session.

To keep track of the training frequency and ensure compliance with training requirements.
12
Have all personnel completed the required cleanroom training?

Select the training status for personnel.

To ensure all staff are adequately trained in cleanroom protocols and contamination control.
13
Please provide a summary of the equipment maintenance logs.

Enter a summary of the maintenance logs.

To ensure that maintenance activities are documented and reviewed for compliance.
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14
Are calibration certificates for all critical equipment available?

Indicate if calibration certificates are available.

To verify that all equipment has valid calibration certificates ensuring compliance.
15
When was the last calibration performed on the critical equipment?

Enter the date of the last calibration.

To ensure that equipment is calibrated regularly for accurate performance.
Min: 0
Target: YYYY-MM-DD
Max: 365
16
Is the equipment maintenance schedule being adhered to?

Select the compliance status of the maintenance schedule.

To ensure that all cleanroom equipment is properly maintained to prevent contamination.
17
Please summarize the review of the environmental monitoring system.

Enter a summary of the environmental monitoring system review.

To ensure that monitoring systems are effective and compliant with cleanroom standards.
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18
Has the emergency power supply been tested recently?

Indicate if the emergency power supply has been tested.

To ensure that emergency systems are functional in case of power failure, maintaining cleanroom integrity.
19
What is the measured air exchange rate in the cleanroom?

Enter the air exchange rate in air changes per hour (ACH).

To verify that the air exchange rate meets the requirements for effective contamination control.
Min: 10
Target: 20
Max: 30
20
Is the HVAC system functioning effectively for cleanroom operations?

Select the functionality status of the HVAC system.

To ensure that the HVAC system is properly regulating temperature and air quality in the cleanroom.

FAQs

The primary purpose is to ensure that pharmaceutical cleanrooms meet the cleanliness and contamination control standards specified in ISO 14644, thereby maintaining product quality and regulatory compliance.

The frequency of audits depends on the cleanroom class and usage, but typically, classification should be confirmed at least annually, with more frequent monitoring for higher-risk environments.

The checklist covers areas such as air particle concentration, air pressure differentials, airflow patterns, temperature and humidity control, and cleanroom garment protocols.

The audit is typically conducted by qualified cleanroom technicians, quality assurance personnel, or third-party auditors with expertise in ISO 14644 standards and cleanroom operations.

By ensuring consistent adherence to ISO 14644 standards, this checklist helps maintain the integrity of cleanroom environments, which is crucial for producing safe and high-quality pharmaceutical products.

Benefits

Ensures compliance with ISO 14644 standards for cleanroom classification

Reduces risk of product contamination and improves quality assurance

Facilitates consistent and thorough cleanroom audits

Helps identify areas for improvement in cleanroom operations

Supports regulatory compliance and documentation requirements