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ISO 14644 Class 8 Modular Cleanroom GMP Pathology Engineering Cleanroom Solution

Categories Prefab Cleanroom
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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ISO 14644 Class 8 Modular Cleanroom GMP Pathology Engineering Cleanroom Solution

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:
CategoryParameterTechnical SpecificationRemarks
Basic ParametersCleanliness ClassISO Class 5-8 (Class 100 to Class 100,000)Customizable to Class 4
Structure TypeModular assembly (wall/ceiling/floor panels)Quick installation
Main Material304 stainless steel/electrolytic steel plate (anti-static coating)Corrosion-resistant
Environmental ControlTemperature Range20-26°C ±1°CIntelligent temperature control
Humidity Range45-65% RH ±5%Auto-regulated
Pressure Control±5-20 Pa adjustableZonal pressure gradient
Air Changes15-60 ACHAdjustable by cleanliness class
Air HandlingFiltration SystemPre-filter G4 + HEPA H13/H1499.97%@0.3μm efficiency
Airflow PatternUnidirectional vertical/horizontal flowFFU coverage ≥30%
Recovery Time≤15 min (ISO 8→5)
Safety FeaturesBiosafetyOptional negative pressure system (-10~-30 Pa)Pathogen containment
Electrical SafetyExplosion-proof lighting/socketsComplies with GB50073
Disinfection CompatibilityResistant to ozone/hydrogen peroxide fumigation
Functional ConfigurationsPass-throughInterlocked stainless steel pass-through with UV sterilizationCustom sizes available
Smart SystemReal-time monitoring (temp/humidity/pressure/particles)Data logging & traceability
Emergency EquipmentEmergency lighting/shutdown systemOptional emergency shower
CertificationsComplianceMeets 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.

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