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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?
2
What is the current pressure differential measurement in the cleanroom?
Min: 0
Target: 0.5
Max: 10
3
Is the airlock functioning correctly to prevent cross-contamination?
4
Please provide any comments or observations regarding the HVAC control system.
5
Is the surface cleanliness within acceptable limits as per ISO 14644?
6
What is the current particulate count in the cleanroom?
Min: 0
Target: 50
Max: 500
7
Are all personnel wearing appropriate personal protective equipment (PPE)?
8
What was the date of the last cleanroom audit?
9
Is the cleanroom temperature within the specified range as per ISO 14644?
10
What is the current humidity level in the cleanroom?
Min: 20
Target: 40
Max: 60
11
Is the air quality within acceptable limits for cleanroom operation?
12
Please provide any notes regarding the calibration of monitoring equipment.
13
Is all cleanroom equipment maintained according to the scheduled maintenance plan?
14
How many equipment failures have occurred in the past month?
Min: 0
Target: 0
Max: 100
15
Are spare parts for critical equipment readily available?
16
What was the date of the last equipment validation?
17
Are all employees trained in cleanroom procedures and protocols?
18
What percentage of employees have completed the required training?
Min: 0
Target: 90
Max: 100
19
Are employees consistently following Standard Operating Procedures (SOPs)?
20
What was the date of the last training session conducted for cleanroom personnel?

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 of ISO 14644 Cleanroom Pressure Cascade System Audit Checklist

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