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Applications and Standards of Cleanrooms in Pathology and Laboratories

Created on 11.14

Introduction

In pathology departments and various laboratories, cleanrooms not only ensure a safe working environment but also play a key role in maintaining sample quality and diagnostic accuracy. Modern pathology labs often require ISO 5–ISO 7 clean zones to support tissue processing, molecular testing, and high-precision instrument operation.
Cleanrooms in Pathology

1. Functions of Pathology Laboratory Cleanrooms

Control airborne particles, microorganisms, and cross-contamination
Ensure the safety and integrity of tissue samples, liquid specimens, and reagents
Maintain stable temperature and humidity to support precision equipment
In histopathology, operating microscopes, microtomes, or cryostats requires a dust-free environment to prevent sample contamination.

2. Common Cleanroom Zones

Sample Receiving Area: ISO 7, used for temporary storage and preliminary processing
Sectioning and Slide Preparation Area: ISO 6–5, ensures dust-free handling
Molecular Pathology / Genetic Testing Area: ISO 5, prevents nucleic acid cross-contamination
Equipment and Storage Area: Cleanliness level set according to instrument sensitivity

3. Airflow and Ventilation Design

Laminar airflow ensures stability in critical zones and prevents particle deposition
HEPA filters capture airborne particles and microorganisms
Air Shower: removes dust particles from personnel or items entering the cleanroom
Pass Box: safely transfers materials and reduces cross-contaminationNote: A Pass Box is a specialized window that allows materials to be transferred between clean and non-clean areas without opening doors, minimizing contamination risk.

4. Personnel Management and Protection

Wear cleanroom garments, hair covers, gloves, and masks
Clear personnel flow paths with zone separation
Training and standardized procedures ensure all operators handle samples correctly

5. Maintenance and Verification

Regular cleanliness testing (particle counting)
Monitoring temperature, humidity, and pressure differentials
Instrument maintenance and calibration records

Conclusion

The scientific design and strict management of pathology laboratory cleanrooms directly impact diagnostic quality and research outcomes. Proper zoning, airflow control, personnel management, and equipment maintenance ensure efficient, safe, and reliable laboratory operations. Using a Pass Box for material transfer and air showers to remove dust from personnel and items further reduces the risk of cross-contamination.
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