Single logo
LoginSign Up

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
4.6

Get Template

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.

Learn more

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?
2
Please provide a description of the cleaning procedures used.
3
What is the frequency of equipment maintenance (in days)?
Min: 1
Target: 30
Max: 90
4
Are the contamination control measures effectively implemented?
5
Is the personal protective equipment (PPE) used compliant with the cleanroom standards?
6
What method is used for airflow validation in the cleanroom?
7
What is the particle count threshold (in particles/m³) established for this cleanroom?
Min: 0
Target: 3500
Max: 3500
8
Is the cleaning equipment regularly maintained and in good working condition?
9
Are the cleanroom staff trained in proper sanitization protocols?
10
What was the date of the last sanitization procedure performed?
11
What is the temperature control range (in °C) maintained in the cleanroom?
Min: 18
Target: 20
Max: 24
12
Are the microbial monitoring results within acceptable limits?
13
Is the environmental monitoring compliant with ISO 14644 standards?
14
Please describe any incidents related to contamination in the cleanroom.
15
What is the humidity control percentage maintained in the cleanroom?
Min: 30
Target: 45
Max: 60
16
Is the cleaning schedule adhered to as per the established protocols?
17
Are the gowning procedures followed as per the cleanroom protocols?
18
What sanitization agent is currently being used in the cleanroom?
19
How often is the cleanroom validated (in months)?
Min: 1
Target: 6
Max: 12
20
Is the waste disposal process compliant with cleanroom standards?

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 of ISO 14644 Cleanroom Maintenance and Sanitization Audit Checklist

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