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ISO 14644 Cleanroom HVAC System Audit Checklist

A detailed checklist for auditing HVAC systems in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on air quality, temperature and humidity control, pressure differentials, and overall system performance to maintain cleanroom integrity.

ISO 14644 Cleanroom HVAC System Audit Checklist

by: audit-now
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About This Checklist

The ISO 14644 Cleanroom HVAC System Audit Checklist is a critical tool for ensuring the optimal performance of heating, ventilation, and air conditioning systems in pharmaceutical cleanrooms. This comprehensive checklist aligns with ISO 14644 standards, focusing on key aspects of HVAC system operation, maintenance, and performance monitoring. By systematically evaluating these systems, pharmaceutical companies can maintain proper air quality, temperature, humidity, and pressure differentials crucial for cleanroom operations. Regular implementation of this checklist enhances contamination control, supports energy efficiency, and ensures compliance with regulatory requirements, ultimately contributing to the integrity of pharmaceutical manufacturing processes.

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Industry

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

HVAC Engineer
Cleanroom Specialist
Facilities Manager
Quality Assurance Auditor
Contamination Control Expert
1
Is the air quality within the cleanroom compliant with ISO 14644 standards?
2
What is the current temperature in the cleanroom?
Min: 20
Target: 20-25
Max: 25
3
What is the current relative humidity in the cleanroom?
Min: 30
Target: 30-60
Max: 60
4
Are the HEPA filters functioning properly?
5
Is the pressure differential within the acceptable range?
6
What is the current energy efficiency rating of the HVAC system?
7
Are the maintenance logs for the HVAC system up to date?
8
How often are the HVAC filters replaced (in days)?
Min: 15
Target: 30
Max: 60
9
When was the last calibration of the HVAC system performed?
10
Is there a plan in place for emergency maintenance of the HVAC system?
11
Is the HVAC system currently operational?
12
What is the current airflow rate in the cleanroom (in CFM)?
Min: 100
Target: 100 - 200
Max: 200
13
Is the noise level of the HVAC system within acceptable limits?
14
Provide any observations regarding the performance of the HVAC system.
15
When is the next scheduled maintenance for the HVAC system?
16
Who are the members of the inspection team?
17
What is the measured air pressure differential (in Pa)?
Min: 15
Target: 15-20
Max: 20
18
Has the maintenance history of the HVAC system been reviewed?
19
When was the last performance review of the HVAC system conducted?
20
Is there a contingency plan in place for HVAC system failures?
21
Were the calibration protocols for the HVAC system followed correctly?
22
What are the current particulate matter levels in the cleanroom (in µg/m³)?
Min: 0
Target: 0-10
Max: 10
23
Describe any recent adjustments made to the HVAC system.
24
When is the next calibration of the HVAC system due?
25
Is the HVAC system compliant with relevant regulations?

FAQs

The checklist covers air handling units, HEPA filtration systems, ductwork integrity, temperature and humidity control systems, pressure differential monitors, and air velocity measurements.

By ensuring proper HVAC system function, the checklist helps maintain appropriate air filtration, air change rates, and pressure differentials, which are crucial for preventing contamination in cleanroom environments.

The audit should involve HVAC engineers, cleanroom specialists, facilities managers, and quality assurance personnel to ensure a comprehensive evaluation of all HVAC system aspects.

Comprehensive audits should be conducted bi-annually, with more frequent checks on critical parameters such as pressure differentials and HEPA filter integrity. Continuous monitoring systems should be checked daily.

Any deficiencies should trigger immediate corrective actions, including system adjustments, component replacements, or recalibration of monitoring devices. A follow-up audit should be scheduled to verify the effectiveness of these actions.

Benefits of ISO 14644 Cleanroom HVAC System Audit Checklist

Ensures HVAC systems meet ISO 14644 standards for cleanroom air quality and environmental control

Helps identify potential issues in HVAC performance before they impact cleanroom operations

Supports energy-efficient operation of cleanroom HVAC systems

Facilitates consistent documentation of HVAC system maintenance and performance

Aids in maintaining proper pressure cascades and air change rates in cleanroom facilities