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GMP Turnkey Project Medical Device Production Workshop Laboratory Biomedical Grade Clean Room

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Product Description

Basic Information
Model NO.AM08-clean room-2025-07-08
StandardStandard
MaterialSteel Panel
Product NameLaboratory Biomedical Grade Clean Room
Selling PointFire Proofing, Thermal Insulated, Big Weight Capacity
Project ServiceDesign, Manufacturing, Construction
Size1150mm Width Height Customized
CleanlinessClass 100-100,000
ColorGray White
Transport PackagePlywood Case
Specification1150*3000*50
OriginChina
HS Code7308900000
Production Capacity10,000 sqm/Month
GMP Turnkey Project Medical Device Production Workshop
GMP Turnkey Project Clean Room
What is a Cleanroom?

A cleanroom is a controlled environment where the concentration of airborne particles is maintained below a specified limit per cubic foot or cubic meter. To achieve this, the rooms are engineered with state-of-the-art ventilation and filtration systems in which each component is carefully selected and placed to ensure an airflow and air quality that is satisfactory for the intended use of the enclosure.

Maintaining an environmentally controlled facility is essential for production and operational flow, as well as product delivery. That's why you need an industry-leading expert to ensure that your facilities meet or exceed every standard!

Cleanroom Environment
ISO 14644-1 Cleanroom Standards
Class Maximum Particles/ m³ FED STD 209E
≥0.1μm ≥0.2μm ≥0.3μm
ISO1102.371.02-
ISO210023.710.2-
ISO31,000237102class 1
ISO410,0002,3701,020class 10
ISO5100,00023,70010,200class 100
ISO61,000,000237,000102,000class 1,000
ISO710,000,0002,370,0001,020,000class 10,000
ISO8100,000,00023,700,00010,200,000class 100,000
ISO Standards Reference
Cleanroom Key Components
1
CLEAN PANEL: The purification board or sandwich panel is a composite board using color-coated steel, stainless steel, or aluminum. It offers unique dustproof, antistatic, and antibacterial advantages for pharmaceuticals, electronics, and aerospace industries.
Clean Panel Structure
2
PURIFICATION DOOR AND WINDOW: Designed for high air tightness and easy cleaning. Windows typically consist of double-layer hollow tempered glass filled with adsorbents to filter harmful particles and gases.
Cleanroom Door and Window
3
FFU (Fan Filter Unit): A modular air supply unit that draws air through a HEPA filter and distributes clean air evenly. Usually installed in ceilings to maximize airflow flexibility.
FFU Unit
Project Gallery
Cleanroom Project 1 Cleanroom Project 2
Cleanroom Project 3 Cleanroom Project 4
Cleanroom Project 5 Cleanroom Project 6
Cleanroom Project 7 Cleanroom Project 8 Cleanroom Project 9
Frequently Asked Questions
Q1: What are the primary applications for biomedical grade cleanrooms?
A: These cleanrooms are essential for medical device production, pharmaceutical labs, biotechnology research, and electronic plant manufacturing where strict control of airborne particles is required.
Q2: How is cleanroom cleanliness classified?
A: Cleanrooms are classified according to ISO 14644-1 standards (ISO 1 to ISO 9) or FED STD 209E (Class 1 to Class 100,000), based on the maximum allowable concentration of particles per cubic meter of air.
Q3: What materials are used in Clean Panels?
A: Clean panels are typically sandwich structures made with color-coated steel, stainless steel, or aluminum alloy surfaces, providing dustproof and antibacterial properties.
Q4: What is the role of an FFU in a cleanroom?
A: The Fan Filter Unit (FFU) is a modular device that contains its own fan and a HEPA filter. It ensures a constant, filtered airflow into the room to maintain the required cleanliness level.
Q5: Why are purification windows double-layered?
A: Double-layer hollow tempered glass provides better thermal insulation and air tightness. The space between layers is often filled with adsorbents to keep the environment free from pollutants like formaldehyde or PM2.5.
Q6: What turnkey services are provided for cleanroom projects?
A: Professional turnkey projects include the complete lifecycle of the cleanroom: from initial design and material manufacturing to professional on-site construction and final validation.

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