ISO 14644 Class 8 Modular Cleanroom GMP Pathology Engineering Cleanroom Solution

The Pathology Department Cleanroom is a modular clean environment specifically designed for hospital pathology labs, CDC facilities, and research institutions. It meets the high-standard operational requirements for pathological sample processing, slide preparation, molecular testing, and more. Through precise temperature and humidity control, air purification, and airflow management, it effectively prevents cross-contamination of samples, ensuring the accuracy and reliability of test results.

• Pathological sample preparation area
• Molecular pathology lab
• Cytology testing room
• Reagent storage area

• Controlled Cleanliness Class: Supports ISO Class 5–8 (Class 100 to Class 100,000) cleanliness levels, adaptable to various pathological testing needs (e.g., immunohistochemistry, PCR).
• Anti-Contamination Design: Adjustable negative/positive pressure zoning, equipped with airtight pass-through windows and high-efficiency filtration (H13/H14) to block aerosols and biological pollutants.

1. What is the lead time for a modular cleanroom?
   The lead time depends on the size, customization, and cleanroom class. Standard configurations typically take 2–4 weeks for production and 1–2 weeks for installation. Custom designs (e.g., ISO Class 4, specialized materials) may require 6–8 weeks. We provide a detailed timeline after evaluating project requirements.
2. Can the cleanroom be relocated or expanded later?
   Yes! Modular cleanrooms are designed for flexibility. Walls, ceilings, and filtration systems can be disassembled and reinstalled at a new site. Expansion is seamless—additional modules integrate with existing structures without compromising cleanliness. Note: Relocation may require revalidation of ISO/GMP standards.
3. How is air cleanliness maintained during power outages?
   Our systems include emergency power options (e.g., UPS/battery backups for FFUs) to sustain airflow briefly. For prolonged outages, we recommend:
   • Redundant power supplies (generators).
   • Airlocks/positive pressure buffers to minimize contamination.
   Post-outage, the cleanroom’s rapid recovery time (≤15 minutes) restores conditions quickly.