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ISO 14644 Cleanroom Maintenance and Sanitization Audit Checklist

A comprehensive checklist for auditing maintenance and sanitization practices in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on cleaning procedures, sanitization protocols, and equipment maintenance to prevent contamination and maintain cleanroom integrity.

ISO 14644 Cleanroom Maintenance and Sanitization Audit Checklist

by: audit-now
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About This Checklist

The ISO 14644 Cleanroom Maintenance and Sanitization Audit Checklist is an indispensable tool for ensuring the ongoing cleanliness and operational efficiency of pharmaceutical cleanrooms. This comprehensive checklist aligns with ISO 14644 standards, focusing on critical aspects of cleanroom maintenance, including cleaning procedures, sanitization protocols, and equipment upkeep. By systematically evaluating these practices, pharmaceutical companies can prevent contamination, extend the life of cleanroom facilities, and maintain consistent compliance with regulatory requirements. Regular use of this checklist enhances cleanroom performance, reduces the risk of product contamination, and supports overall quality assurance efforts in pharmaceutical manufacturing.

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Industry

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Cleanroom Manager
Quality Assurance Specialist
Facilities Maintenance Technician
Contamination Control Officer
Pharmaceutical Production Supervisor
1
Are the sanitization protocols compliant with ISO 14644 standards?

Select compliance status.

To ensure that the sanitization practices meet the necessary regulatory requirements.
2
Please provide a description of the cleaning procedures used.

Enter the cleaning procedure details.

To verify that the cleaning procedures are well defined and followed.
3
What is the frequency of equipment maintenance (in days)?

Enter the maintenance frequency.

To ensure that equipment maintenance is performed regularly to prevent contamination.
Min: 1
Target: 30
Max: 90
4
Are the contamination control measures effectively implemented?

Select the level of implementation.

To assess the effectiveness of contamination control procedures.
5
Is the personal protective equipment (PPE) used compliant with the cleanroom standards?

Select compliance status.

To ensure that personnel are properly protected to minimize contamination risk.
6
What method is used for airflow validation in the cleanroom?

Describe the airflow validation method.

To evaluate the effectiveness of airflow management for contamination control.
7
What is the particle count threshold (in particles/m³) established for this cleanroom?

Enter the particle count threshold.

To ensure that the cleanroom meets the required cleanliness levels.
Min: 0
Target: 3500
Max: 3500
8
Is the cleaning equipment regularly maintained and in good working condition?

Select the maintenance status.

To confirm that cleaning equipment is effective and reliable for maintaining cleanliness.
9
Are the cleanroom staff trained in proper sanitization protocols?

Select training compliance status.

To ensure that staff are adequately trained to prevent contamination.
10
What was the date of the last sanitization procedure performed?

Enter the last sanitization date.

To track the frequency of sanitization and ensure compliance with schedule.
11
What is the temperature control range (in °C) maintained in the cleanroom?

Enter the maintained temperature range.

To ensure that environmental conditions are within the specified limits for product safety.
Min: 18
Target: 20
Max: 24
12
Are the microbial monitoring results within acceptable limits?

Select monitoring result status.

To confirm the effectiveness of contamination control measures.
13
Is the environmental monitoring compliant with ISO 14644 standards?

Select compliance status.

To ensure that environmental conditions continuously meet regulatory requirements.
14
Please describe any incidents related to contamination in the cleanroom.

Provide details of any incidents.

To assess past issues and their resolutions to improve future practices.
15
What is the humidity control percentage maintained in the cleanroom?

Enter the maintained humidity percentage.

To ensure that humidity levels are controlled to prevent contamination.
Min: 30
Target: 45
Max: 60
16
Is the cleaning schedule adhered to as per the established protocols?

Select adherence status.

To confirm that regular cleaning is performed to maintain cleanliness standards.
17
Are the gowning procedures followed as per the cleanroom protocols?

Select compliance status.

To ensure that personnel are properly gowned to minimize contamination risks.
18
What sanitization agent is currently being used in the cleanroom?

Enter the name of the sanitization agent.

To ensure that appropriate and effective sanitization agents are utilized.
19
How often is the cleanroom validated (in months)?

Enter the validation frequency.

To ensure that the cleanroom is regularly validated to meet compliance standards.
Min: 1
Target: 6
Max: 12
20
Is the waste disposal process compliant with cleanroom standards?

Select compliance status.

To confirm that waste is disposed of in a manner that prevents contamination.

FAQs

The checklist covers cleaning schedules, sanitization procedures, equipment maintenance logs, cleaning agent efficacy, personnel training records, and documentation of cleaning validation studies.

By ensuring regular and thorough cleaning and sanitization practices, the checklist helps maintain a consistently low microbial and particulate load in the cleanroom environment, reducing contamination risks.

The audit should be conducted by a team including quality assurance personnel, cleanroom managers, and facilities maintenance staff, with oversight from contamination control specialists.

Comprehensive audits should be conducted quarterly, with more frequent checks on critical cleaning and sanitization processes. Daily and weekly checks should also be incorporated into routine operations.

Any identified gaps should trigger immediate corrective actions, including revision of cleaning protocols, retraining of personnel, and implementation of more rigorous monitoring processes to prevent future lapses.

Benefits

Ensures adherence to ISO 14644 standards for cleanroom maintenance and sanitization

Reduces risk of contamination through systematic evaluation of cleaning practices

Prolongs the operational life of cleanroom facilities and equipment

Supports consistent and thorough documentation of maintenance activities

Facilitates continuous improvement in cleanroom hygiene and operational efficiency