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ISO 14644 Class 8 Modular Cleanroom GMP Pathology Engineering Cleanroom Solution

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ISO 14644 Class 8 Modular Cleanroom GMP Pathology Engineering Cleanroom Solution

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Brand Name : GCC

Certification : ISO9001,ISO14001,ISO45001,CE

Place of Origin : China

MOQ : 1

Price : Negotiation

Payment Terms : T/T

Supply Ability : Manufacturer

Delivery Time : 10-14

Packaging Details : Wooden Box

Test Report : Provide

Project : Pathology Workshop Cleanroom

Electrical System : UL listed components

Frame Material : Stainless Steel/Iron

Type : Purification

Air Change Rate : 100-600 times/hour

Hepa Filter : Efficiency ≥99.999% at 0.3μm

Ceiling Panels : Anti-static PVC panels

Doors : Single or double swing doors

Power Supply : 220V, 50Hz

Quality Check : Delivery Inspection Video

Condition : New

Voltage : 220V/50HZ

HEPA Filter : H13/H14

Application : PCR room

Feature : Advanced Design and Engineering

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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.
✅Typical Applications:
• 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..
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.


Product Tags:

Pathology Modular Cleanroom

      

GMP Workshop Modular Cleanroom

      

ISO 14644 Class 8 Modular Cleanroom

      
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