ISO 14644 Class 8 Modular Cleanroom GMP Pathology Engineering Cleanroom Solution
Brand Name:GCC
Certification:ISO9001,ISO14001,ISO45001,CE
Minimum Order Quantity:1
Delivery Time:10-14
Payment Terms:T/T
Place of Origin:China
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Location:
Guangzhou Guangdong China
Address:
102, Building 4, No. 23 Yongfeng Road, Yongshan Village, Shiqi Town, Panyu District, Guangzhou City, Guangdong Province
Supplier`s last login times:
within 42 hours
Product Details
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Product Details
Professional Clean Environment Ensuring Accurate and Safe
Pathological Testing
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.
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.
✅Typical Applications:
• Pathological sample preparation area
• Molecular pathology lab
• Cytology testing room
• Reagent storage area
• Pathological sample preparation area
• Molecular pathology lab
• Cytology testing room
• Reagent storage area
Core Advantages:
✅ 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..
✅ 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..
Main on Technical:
| Category | Parameter | Technical Specification | Remarks |
| Basic Parameters | Cleanliness Class | ISO Class 5-8 (Class 100 to Class 100,000) | Customizable to Class 4 |
| Structure Type | Modular assembly (wall/ceiling/floor panels) | Quick installation | |
| Main Material | 304 stainless steel/electrolytic steel plate (anti-static coating) | Corrosion-resistant | |
| Environmental Control | Temperature Range | 20-26°C ±1°C | Intelligent temperature control |
| Humidity Range | 45-65% RH ±5% | Auto-regulated | |
| Pressure Control | ±5-20 Pa adjustable | Zonal pressure gradient | |
| Air Changes | 15-60 ACH | Adjustable by cleanliness class | |
| Air Handling | Filtration System | Pre-filter G4 + HEPA H13/H14 | 99.97%@0.3μm efficiency |
| Airflow Pattern | Unidirectional vertical/horizontal flow | FFU coverage ≥30% | |
| Recovery Time | ≤15 min (ISO 8→5) | ||
| Safety Features | Biosafety | Optional negative pressure system (-10~-30 Pa) | Pathogen containment |
| Electrical Safety | Explosion-proof lighting/sockets | Complies with GB50073 | |
| Disinfection Compatibility | Resistant to ozone/hydrogen peroxide fumigation | ||
| Functional Configurations | Pass-through | Interlocked stainless steel pass-through with UV sterilization | Custom sizes available |
| Smart System | Real-time monitoring (temp/humidity/pressure/particles) | Data logging & traceability | |
| Emergency Equipment | Emergency lighting/shutdown system | Optional emergency shower | |
| Certifications | Compliance | Meets GMP/GLP, WS 233-2017 "Biosafety in Pathogen Laboratories" | Validation documents provided |
FAQ:
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.
ISO 14644 Class 8 Modular Cleanroom GMP Pathology Engineering Cleanroom Solution
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