Single logo
LoginSign Up

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
4.8

Get Template

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.

Learn more

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?
2
Is the integrity of the pass-through chambers maintained?
3
What is the measured efficiency percentage of the material decontamination process?
Min: 90
Target: 95
Max: 100
4
Provide comments or observations on the current material handling procedures.
5
Are the contamination control measures in place effective according to ISO 14644 standards?
6
What is the current completion status of training for cleanroom staff regarding material transfer?
7
What is the measured particulate count in the cleanroom air?
Min: 0
Target: 100
Max: 500
8
When was the last audit conducted for material transfer processes?
9
Is the calibration status of the material transfer equipment up to date?
10
Are all personnel wearing the required personal protective equipment (PPE) during material transfer?
11
What is the average time taken for material transfers (in minutes)?
Min: 5
Target: 15
Max: 30
12
Provide details of any incident reports related to material transfer in the last review period.
13
Is the cleanroom access control compliant with ISO 14644 requirements?
14
How accurate is the log of material transfers documented?
15
What is the current level of contamination (in CFU/m³) measured in the cleanroom?
Min: 0
Target: 50
Max: 100
16
When is the next scheduled maintenance for cleanroom equipment?
17
Is the material receipt inspection process compliant with ISO 14644 standards?
18
Is the environmental monitoring system fully functional and operational?
19
What is the compliance rate for personnel hygiene practices (in percentage)?
Min: 90
Target: 98
Max: 100
20
Provide any observations or recommendations regarding the current material transfer procedures.

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