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ISO 14644 Cleanroom Material Transfer Audit Checklist

A detailed checklist for auditing material transfer practices in pharmaceutical cleanrooms to ensure compliance with ISO 14644 standards, focusing on transfer protocols, decontamination procedures, and contamination prevention during the movement of materials and equipment.

ISO 14644 Cleanroom Material Transfer Audit Checklist

by: audit-now
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About This Checklist

The ISO 14644 Cleanroom Material Transfer Audit Checklist is a vital tool for ensuring the integrity of pharmaceutical cleanrooms during the critical process of material transfer. This comprehensive checklist aligns with ISO 14644 standards, focusing on procedures and controls for moving materials, equipment, and supplies in and out of cleanroom environments. By systematically evaluating these transfer processes, pharmaceutical companies can prevent contamination, maintain cleanroom classification, and ensure compliance with regulatory requirements. Regular implementation of this checklist enhances overall contamination control, supports product quality, and optimizes cleanroom operations by addressing one of the most common sources of potential contamination.

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Industry

Healthcare

Standard

ISO 14644 - Cleanroom Standards

Workspaces

Pharmaceutical Facilities

Occupations

Cleanroom Manager
Quality Assurance Specialist
Material Handler
Contamination Control Officer
Pharmaceutical Production Supervisor
1
Are the material transfer protocols in compliance with ISO 14644?

Select compliance status.

To ensure that material transfer processes follow the required standards for contamination control.
2
Is the integrity of the pass-through chambers maintained?

Indicate if integrity is maintained.

To verify that pass-through chambers are not compromising cleanroom conditions.
3
What is the measured efficiency percentage of the material decontamination process?

Enter the efficiency percentage.

To assess the effectiveness of decontamination procedures.
Min: 90
Target: 95
Max: 100
4
Provide comments or observations on the current material handling procedures.

Enter your comments.

To gather qualitative feedback on material handling practices.
5
Are the contamination control measures in place effective according to ISO 14644 standards?

Select effectiveness status.

To evaluate the effectiveness of contamination control in the cleanroom environment.
6
What is the current completion status of training for cleanroom staff regarding material transfer?

Enter the training completion status.

To ensure that staff are adequately trained to minimize contamination risks.
7
What is the measured particulate count in the cleanroom air?

Enter the particulate count.

To assess air quality in relation to contamination control standards.
Min: 0
Target: 100
Max: 500
8
When was the last audit conducted for material transfer processes?

Select the date of the last audit.

To maintain a timeline of audits and ensure regular evaluation.
9
Is the calibration status of the material transfer equipment up to date?

Select the calibration status.

To ensure that equipment used in material transfer is calibrated correctly to prevent contamination.
10
Are all personnel wearing the required personal protective equipment (PPE) during material transfer?

Indicate if PPE compliance is upheld.

To ensure compliance with safety and contamination control protocols.
11
What is the average time taken for material transfers (in minutes)?

Enter the average transfer time in minutes.

To evaluate efficiency in material transfer processes.
Min: 5
Target: 15
Max: 30
12
Provide details of any incident reports related to material transfer in the last review period.

Enter incident report details.

To identify and address potential issues that could impact contamination control.
13
Is the cleanroom access control compliant with ISO 14644 requirements?

Select the access control compliance status.

To ensure that access to the cleanroom is properly controlled to prevent contamination.
14
How accurate is the log of material transfers documented?

Describe the accuracy of the material transfer log.

To verify that all material transfers are accurately logged for traceability.
15
What is the current level of contamination (in CFU/m³) measured in the cleanroom?

Enter the contamination level in CFU/m³.

To assess if contamination levels are within acceptable limits.
Min: 0
Target: 50
Max: 100
16
When is the next scheduled maintenance for cleanroom equipment?

Select the date for the next maintenance.

To ensure that equipment is regularly maintained to support contamination control.
17
Is the material receipt inspection process compliant with ISO 14644 standards?

Select the inspection compliance status.

To ensure that incoming materials are inspected thoroughly to prevent contamination.
18
Is the environmental monitoring system fully functional and operational?

Indicate if the monitoring system is operational.

To confirm that the monitoring system is working to track contamination risks.
19
What is the compliance rate for personnel hygiene practices (in percentage)?

Enter the hygiene compliance rate in percentage.

To evaluate adherence to hygiene protocols that minimize contamination risks.
Min: 90
Target: 98
Max: 100
20
Provide any observations or recommendations regarding the current material transfer procedures.

Enter your observations or recommendations.

To gather insights on potential improvements to enhance contamination control.

FAQs

The checklist covers transfer protocols, pass-through chamber operations, material decontamination procedures, packaging requirements, documentation practices, and personnel training for material handling in cleanroom environments.

By ensuring proper procedures are followed during material transfers, the checklist helps prevent the introduction of contaminants and maintains the cleanliness classification of the cleanroom.

The audit should involve cleanroom managers, quality assurance personnel, material handlers, and contamination control specialists to ensure a comprehensive evaluation of all aspects of the transfer process.

Comprehensive audits should be conducted monthly, with daily checks on critical transfer points. More frequent audits may be necessary for high-volume or high-risk transfer areas.

Deficiencies should trigger immediate corrective actions, including revision of transfer protocols, retraining of personnel, and potential modifications to transfer equipment or facilities. A follow-up audit should be scheduled to verify the effectiveness of these actions.

Benefits of ISO 14644 Cleanroom Material Transfer Audit Checklist

Ensures material transfer practices comply with ISO 14644 standards for cleanroom operations

Reduces risk of contamination during material and equipment movement

Promotes consistent adherence to transfer protocols and decontamination procedures

Facilitates traceability and documentation of materials entering and exiting cleanrooms

Supports overall contamination control strategy in pharmaceutical manufacturing