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ISO 14644 Cleanroom Pressure Cascade System Audit Checklist

A comprehensive checklist for auditing pressure cascade systems in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on the evaluation, maintenance, and monitoring of pressure differentials to prevent contamination between areas of different cleanliness classifications.

ISO 14644 Cleanroom Pressure Cascade System Audit Checklist

by: audit-now
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About This Checklist

The ISO 14644 Cleanroom Pressure Cascade System Audit Checklist is a vital tool for ensuring the integrity of pressure differentials in pharmaceutical cleanroom environments. This comprehensive checklist aligns with ISO 14644 standards, focusing on the evaluation, maintenance, and monitoring of pressure cascade systems that prevent contamination between cleanroom areas of different classifications. By systematically auditing pressure cascade systems, pharmaceutical companies can enhance contamination control, maintain proper air cleanliness levels, and ensure compliance with regulatory requirements. Regular implementation of this checklist supports the overall cleanroom performance, aids in identifying potential breaches in containment, and contributes to product quality assurance in pharmaceutical manufacturing.

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Industry

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Cleanroom Engineer
HVAC Specialist
Quality Assurance Auditor
Facilities Manager
Contamination Control Expert
1
Is the cleanroom pressure differential maintained within the specified limits?

Select the pressure differential status.

To ensure that the cleanroom is functioning properly and preventing contamination.
2
What is the current pressure differential measurement in the cleanroom?

Enter the pressure differential in Pascals.

To quantify the pressure levels for compliance with ISO standards.
Min: 0
Target: 0.5
Max: 10
3
Is the airlock functioning correctly to prevent cross-contamination?

Select the airlock functionality status.

To assess the airlock's effectiveness in maintaining cleanroom integrity.
4
Please provide any comments or observations regarding the HVAC control system.

Enter your comments here.

To document any issues or improvements needed for the HVAC system.
5
Is the surface cleanliness within acceptable limits as per ISO 14644?

Select the surface cleanliness status.

To ensure that surfaces are maintained to prevent contamination.
6
What is the current particulate count in the cleanroom?

Enter the particulate count per cubic meter.

To monitor the level of airborne particulates against ISO standards.
Min: 0
Target: 50
Max: 500
7
Are all personnel wearing appropriate personal protective equipment (PPE)?

Select true if PPE is being worn, otherwise select false.

To ensure compliance with contamination control protocols.
8
What was the date of the last cleanroom audit?

Select the date of the last audit.

To track the frequency of audits and ensure compliance.
9
Is the cleanroom temperature within the specified range as per ISO 14644?

Select the temperature control status.

To ensure that temperature is maintained to support product integrity.
10
What is the current humidity level in the cleanroom?

Enter the humidity level in percentage.

To monitor humidity levels for compliance with environmental control standards.
Min: 20
Target: 40
Max: 60
11
Is the air quality within acceptable limits for cleanroom operation?

Select the air quality status.

To assess the effectiveness of air filtration systems in maintaining air quality.
12
Please provide any notes regarding the calibration of monitoring equipment.

Enter your notes here.

To document calibration status and any issues related to monitoring equipment.
13
Is all cleanroom equipment maintained according to the scheduled maintenance plan?

Select the equipment maintenance status.

To ensure equipment reliability and compliance with operational standards.
14
How many equipment failures have occurred in the past month?

Enter the number of equipment failures.

To monitor equipment reliability and identify potential issues.
Min: 0
Target: 0
Max: 100
15
Are spare parts for critical equipment readily available?

Select true if spare parts are available, otherwise select false.

To ensure that maintenance can be performed without delay.
16
What was the date of the last equipment validation?

Select the date of the last validation.

To ensure that equipment meets performance and regulatory standards.
17
Are all employees trained in cleanroom procedures and protocols?

Select the training status of employees.

To ensure that personnel are knowledgeable about contamination control and cleanroom operations.
18
What percentage of employees have completed the required training?

Enter the percentage of completed training.

To evaluate overall compliance and readiness of personnel in cleanroom practices.
Min: 0
Target: 90
Max: 100
19
Are employees consistently following Standard Operating Procedures (SOPs)?

Select true if SOPs are being followed, otherwise select false.

To ensure adherence to established protocols for contamination control.
20
What was the date of the last training session conducted for cleanroom personnel?

Select the date of the last training session.

To keep track of training frequency and ensure timely updates.

FAQs

The checklist covers pressure differential measurements, airlock functionality, door interlock systems, alarm and monitoring systems, HVAC control parameters, and documentation of pressure readings and system maintenance.

A properly maintained pressure cascade system ensures that air flows from areas of higher cleanliness to areas of lower cleanliness, preventing the ingress of contaminants and maintaining the required cleanliness levels in critical areas.

The audit should involve cleanroom engineers, HVAC specialists, quality assurance personnel, facilities managers, and contamination control experts to ensure a comprehensive evaluation of the pressure cascade system.

Comprehensive audits should be conducted quarterly, with continuous monitoring of pressure differentials. More frequent checks may be necessary for critical manufacturing areas or following any changes to the HVAC system.

Identified deficiencies should trigger immediate corrective actions, such as recalibration of pressure sensors, adjustment of HVAC settings, or repair of door seals. A follow-up audit should be scheduled to verify the effectiveness of these actions and ensure system stability.

Benefits

Ensures pressure cascade systems comply with ISO 14644 standards for cleanroom operations

Prevents cross-contamination between areas of different cleanliness levels

Optimizes airflow direction and containment in critical manufacturing areas

Supports early detection of potential breaches in cleanroom integrity

Enhances overall contamination control strategy in pharmaceutical facilities