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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

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Cleanroom Technician
Quality Assurance Specialist
Pharmaceutical Engineer
Contamination Control Specialist
Regulatory Compliance Officer
1
Is the cleanroom compliant with the required ISO 14644 classification?
2
What is the air particle concentration measured in the cleanroom?
Min: 0
Target: 100
Max: 1000
3
Are contamination control procedures documented and being followed?
4
Are personnel wearing the required personal protective equipment (PPE)?
5
Please provide the latest temperature and humidity records from the cleanroom environment.
6
What is the measured airflow velocity in the cleanroom?
Min: 0
Target: 0.45
Max: 1.5
7
Is the filter integrity testing up to date and compliant?
8
Is all monitoring equipment calibrated and functioning correctly?
9
Have all personnel completed the required cleanroom training?
10
When was the last training session conducted for cleanroom personnel?
11
How many training sessions have been conducted in the last year?
Min: 0
Target: 6
Max: 100
12
Please provide a summary of the training materials used for cleanroom training.
13
Is the equipment maintenance schedule being adhered to?
14
When was the last calibration performed on the critical equipment?
Min: 0
Target: YYYY-MM-DD
Max: 365
15
Are calibration certificates for all critical equipment available?
16
Please provide a summary of the equipment maintenance logs.
17
Is the HVAC system functioning effectively for cleanroom operations?
18
What is the measured air exchange rate in the cleanroom?
Min: 10
Target: 20
Max: 30
19
Has the emergency power supply been tested recently?
20
Please summarize the review of the environmental monitoring system.

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 of ISO 14644 Cleanroom Classification Audit Checklist

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