Single logo
LoginSign Up

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
4.5

Get Template

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.

Learn more

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?

Select compliance status.

To ensure that the air quality meets the required cleanliness levels for pharmaceutical production.
2
What is the current temperature in the cleanroom?

Enter temperature in degrees Celsius.

To verify that the temperature is maintained within the specified limits for product integrity.
Min: 20
Target: 20-25
Max: 25
3
What is the current relative humidity in the cleanroom?

Enter humidity percentage.

To ensure that humidity levels are kept within acceptable ranges to prevent contamination.
Min: 30
Target: 30-60
Max: 60
4
Are the HEPA filters functioning properly?

Select filter status.

To confirm that HEPA filtration systems are operational to prevent contamination.
5
Is the pressure differential within the acceptable range?

Select pressure differential status.

To ensure that the cleanroom maintains the necessary pressure differential to prevent contamination ingress.
6
What is the current energy efficiency rating of the HVAC system?

Select the energy efficiency rating.

To assess whether the HVAC system is operating within energy-efficient parameters to reduce operational costs.
7
Are the maintenance logs for the HVAC system up to date?

Provide details regarding the last maintenance check.

To ensure that regular maintenance is being performed and documented properly.
8
How often are the HVAC filters replaced (in days)?

Enter the frequency of filter changes.

To determine if the filter replacement schedule is adequate to maintain air quality.
Min: 15
Target: 30
Max: 60
9
When was the last calibration of the HVAC system performed?

Enter the date of the last calibration.

To verify that the system is calibrated regularly for optimal performance.
10
Is there a plan in place for emergency maintenance of the HVAC system?

Select the preparedness level.

To ensure readiness for any unexpected HVAC system failures.
11
Is the HVAC system currently operational?

Select the operational status.

To confirm that the HVAC system is functioning and capable of maintaining cleanroom conditions.
12
What is the current airflow rate in the cleanroom (in CFM)?

Enter airflow rate in Cubic Feet per Minute.

To ensure that the airflow rate meets the required standards for maintaining cleanroom conditions.
Min: 100
Target: 100 - 200
Max: 200
13
Is the noise level of the HVAC system within acceptable limits?

Indicate whether the noise level is acceptable.

To ensure that the noise generated by the HVAC system does not interfere with operations.
14
Provide any observations regarding the performance of the HVAC system.

Enter detailed observations.

To document any potential issues or observations that may affect system performance.
15
When is the next scheduled maintenance for the HVAC system?

Enter the date of the next scheduled maintenance.

To keep track of maintenance schedules and ensure timely servicing.
16
Who are the members of the inspection team?

List the names of all team members involved in the inspection.

To identify responsible personnel involved in the HVAC system inspection.
17
What is the measured air pressure differential (in Pa)?

Enter the air pressure differential in Pascals.

To ensure that the air pressure differentials are within acceptable ranges for cleanroom standards.
Min: 15
Target: 15-20
Max: 20
18
Has the maintenance history of the HVAC system been reviewed?

Select the status of the maintenance history review.

To confirm that past maintenance activities have been evaluated for compliance and effectiveness.
19
When was the last performance review of the HVAC system conducted?

Enter the date of the last performance review.

To ensure that regular performance evaluations are taking place to maintain system efficacy.
20
Is there a contingency plan in place for HVAC system failures?

Select the status of the contingency plan.

To ensure preparedness for unexpected HVAC system failures that could affect cleanroom conditions.
21
Were the calibration protocols for the HVAC system followed correctly?

Select the status of calibration protocol adherence.

To verify that the calibration processes are adhered to in order to maintain system accuracy.
22
What are the current particulate matter levels in the cleanroom (in µg/m³)?

Enter the particulate matter levels in micrograms per cubic meter.

To ensure that particulate matter levels are within acceptable limits to protect product integrity.
Min: 0
Target: 0-10
Max: 10
23
Describe any recent adjustments made to the HVAC system.

Provide details of recent adjustments.

To document any modifications that could affect system performance and compliance.
24
When is the next calibration of the HVAC system due?

Enter the due date for the next calibration.

To ensure timely calibration for optimal system performance.
25
Is the HVAC system compliant with relevant regulations?

Select the compliance status.

To confirm adherence to regulatory requirements for HVAC systems in pharmaceutical cleanrooms.

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