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Class 100 Pre Engineered Medical Device Cleanrooms Dust Free
| Brand Name: | SHP |
| Model Number: | Customized |
| MOQ: | 50 square meters |
| Price: | $500.00/square meters 50-499 square meters |
| Payment Terms: | L/C,T/T |
| Supply Ability: | ≥1 set |
Pre Engineered Medical Device Cleanrooms
,Dust Free Medical Device Cleanrooms
,Class 100 Medical Device Manufacturing Clean Room
Elite Pre-Engineered Dust-Free Facility with Airtight Structural Sealing for General High-End Manufacturing
Product Overview
Technical Reference Data
The following data provides reference configurations for SHP cleanroom systems and related purification equipment. The actual cleanroom dimensions, airflow rates, filtration setup, pressure differential and environmental-control parameters depend on the required cleanliness classification, the production process and the project design.
Cleanroom System Reference Configuration
| Item | Reference Configuration |
| Cleanroom Type | Modular / Prefabricated Cleanroom |
| Cleanliness Classification | Class 100–100,000 or applicable ISO classification |
| Cleanroom Structure | Modular wall and ceiling panel system |
| Air Purification | HEPA / FFU filtration system |
| HVAC | AHU-based or project-specific HVAC system |
| Air Distribution | FFU ceiling array / ducted air distribution |
| Flooring | Epoxy coating or anti-static PVC flooring |
| Cleanroom Doors | Sealed cleanroom doors |
| Cleanroom Windows | Flush-mounted observation windows |
| Lighting | Cleanroom LED lighting |
| Pressure Control | Positive or negative pressure according to process requirements |
| Environmental Control | Temperature and relative humidity controlled according to project requirements |
| Monitoring | Particle, airflow, pressure and environmental monitoring where required |
FFU Reference Data
| Item | Reference Specification |
| Equipment Type | Fan Filter Unit (FFU) |
| Air Velocity | Approx. 0.45 m/s |
| HEPA Filtration Efficiency | ≥99.995% @ 0.3 μm |
| Power Supply | 220 V / 50 Hz |
| Noise Level | ≤65 dB |
| Housing Options | SS304 / Powder-Coated Steel |
| Speed Control | Speed Controller / Speed Display |
| Installation | Ceiling-mounted or integrated into modular cleanroom ceiling |
HEPA Box Reference Data
| Item | Reference Specification |
| Model | SHPHB-001 |
| HEPA Filter Size | 410 × 410 × 93 mm |
| HEPA Box Size | 455 × 455 × 380 mm |
| Connector Size | 200 × 200 mm |
| Air Volume | 500 m³/h* |
| Installation | Cleanroom ceiling / air supply system |
*Air volume and other operating parameters should be confirmed according to the selected equipment configuration and project design.
Cleanroom Environmental Control
| Parameter | Engineering Reference |
| Airborne Particles | Controlled according to required ISO classification |
| Airflow | Designed according to room classification and process requirements |
| Differential Pressure | Positive / negative pressure according to process zoning |
| Temperature | Project-specific |
| Relative Humidity | Project-specific |
| Air Changes | Determined by cleanroom classification, heat load and process requirements |
| Filtration | HEPA filtration; additional filtration stages where required |
| Cross-Contamination Control | Airflow zoning, pressure relationships and personnel/material flow design |
Cleanroom Enclosure Materials
| Component | Typical Material / Configuration |
| Wall Panels | Sandwich panel system |
| Ceiling Panels | Sandwich panel system |
| Panel Core | Rock wool or other specified core material |
| Surface Finish | Project-specific cleanroom coating / coated steel surface |
| Doors | Cleanroom sealed door |
| Windows | Double-glazed / flush observation window according to project requirements |
| Floor | Epoxy or anti-static PVC |
| Joints | Sealed cleanroom joints and penetrations |
Supporting Cleanroom Equipment
The cleanroom system can be integrated with supporting equipment according to the project scope:
- Air Shower
- Fan Filter Unit (FFU)
- HEPA Box
- Pass Box
- Clean Bench
- Laminar Air Flow Cabinet
- AHU
- Chiller
- Cleanroom Doors and Windows
- Cleanroom Lighting
Testing & Performance Verification
Once installation and commissioning are complete, the applicable cleanroom performance parameters can be tested in line with the agreed project requirements.
Typical verification items include:
- Airborne Particle Count
- Airflow Measurement
- Differential Pressure
- Temperature
- Relative Humidity
- HEPA / FFU Performance
- Cleanroom Enclosure Integrity
Where included in the project scope, testing and validation documentation may include commissioning records, cleanroom test reports, DQ, IQ, OQ and PQ documentation.
Engineering Note: The values listed above are reference data, not guaranteed parameters for every project. Final equipment selection and cleanroom performance criteria should be confirmed through the approved engineering design, applicable standards and project-specific requirements.
Cleanroom Description
| Application | Pharmaceutical | Lab | Electronics |
| Cleanliness | Class 100–100000 or applicable ISO/GMP classification | ISO 5–8 or project-specific classification | ISO 5–8 or project-specific classification |
| Scope |
Structure part; Partition and ceiling panel; door and window,epoxy. |
HVAC part; AHU and chiller; Ducting and piping. |
Electrical part; Lamp,switch and socket; Distribution cabinet. |
| Service | Design and production | Construction and test | Validation and training |
| Wall/ceiling panel | Machine-made or Hand-made sandwich board |
| Clean room equipment | Air shower,FFU,Pass box,Laminar flow cabinet,hepa box |
| Cleanliness | Class 100-100000 |
| Purification system | HVAC, or AC conditioner+FFU |
| Floor | PVC anti-static floor or epoxy-based coating |
| Other addessores | stalinite window,LED panel light,Door,Hand wash sink,storage/shoe cabinet etc |
| Service | Design,manufacturing,construction |
Cleanroom Core Functions
1. Filters the Invisible
It takes air you can't see and removes what shouldn't be there — down to the last 0.1-micron particle. What reaches your product is nothing but clean.
2. Moves Air With Purpose
Air doesn't drift. It flows. Downward at 0.45 meters per second, carrying every loose particle to the floor and out of the equation before it becomes a defect.
3. Holds the Climate
Half a degree either way can ruin a batch. This room doesn't flinch — temperature and humidity stay locked, regardless of weather, equipment, or how many people walk through.
4. Builds Walls Out of Air
No physical barrier between zones — just pressure. Five to fifteen Pascals of positive offset, and contamination can only move one direction: out.
5. Leaves No Place for Dust
Flat joints, rounded corners, sealed seams. If dust can't find a ledge, it can't accumulate. If it can't accumulate, it can't become a problem.
6. Grounds What You Can't Feel
Static charges build silently and kill instantly. The floor and grounding grid give that charge exactly one path — straight to earth, nowhere near your components.
7. Cleans Everything That Enters
People go through a 25-meter-per-second wind tunnel. Materials pass under UV light. Nothing crosses the threshold carrying what it picked up outside.
8. Never Stops Watching
Particle counters, pressure sensors, temperature probes — live, continuous, recorded. If something drifts, the alarm sounds before the product suffers. If an auditor asks, the data answers.
9. Spends Power Intelligently
Full speed when needed, idle when not. Sixty to eighty percent of exhaust heat recovered and reused. Cleanliness without waste.
10. Proves Itself on Paper
Tested. Documented. Certified. Leak checks, smoke studies, recovery runs, temperature maps — every number verified, every result filed, every audit passed.
In short: A cleanroom doesn't just provide a space. It guarantees an environment — measured, monitored, maintained, and proven — where contamination is not a probability to manage but a variable that has been eliminated.
Cleanroom Applications
Pharmaceutical & Biotechnology
Modular cleanroom systems can be configured for pharmaceutical and biotechnology applications requiring controlled airborne contamination, environmental conditions and pressure relationships.
Laboratory & R&D
Prefabricated cleanrooms can be adapted for laboratory, testing and research environments according to the required cleanliness classification and process conditions.
Electronics & Semiconductor
Cleanroom configurations can support electronics and precision manufacturing processes where airborne particle and environmental control are important.
Medical & Healthcare
Cleanroom systems can be configured for selected medical, healthcare and controlled production environments according to applicable project requirements.
Engineering Process
SHP's cleanroom projects follow a structured engineering process from initial requirement assessment through installation, commissioning and performance verification. The actual scope and sequence depend on the cleanroom classification, the production process, facility conditions and project requirements.
1. Requirement Assessment
The engineering team examines the intended application, the required cleanliness classification, room functions, personnel and material flows, production equipment, environmental conditions and available utilities. These requirements provide the basis for the cleanroom layout and system configuration.
2. Cleanroom Layout & Engineering Design
On the basis of the confirmed requirements, SHP prepares the cleanroom layout and coordinates the enclosure structure, ceiling system, HVAC, air distribution, HEPA/FFU filtration, electrical systems, doors, windows and supporting equipment. Airflow direction, pressure relationships and maintenance access are considered as part of the system design.
3. Equipment & Component Selection
Cleanroom panels, FFUs, HEPA filtration units, AHUs, air showers, pass boxes, cleanroom doors and other components are selected according to the approved technical requirements. Equipment specifications are reviewed for compatibility with the overall cleanroom system.
4. Manufacturing & Quality Inspection
Cleanroom panels and related equipment are produced according to the approved specifications. Dimensions, materials, component configuration and other applicable quality-control points are inspected before shipment. Manufacturing and inspection records can be supplied in line with the project documentation requirements.
5. On-Site Installation
The cleanroom enclosure, HVAC and filtration systems, electrical components and supporting equipment are installed according to the approved layout. As part of the installation process, panel joints, ceiling interfaces, doors, windows and service penetrations are sealed and inspected.
6. Commissioning & System Adjustment
After installation, the HVAC and purification systems are commissioned. Airflow distribution, pressure relationships and environmental-control settings are adjusted according to the project design and required operating conditions.
7. Performance Testing & Verification
The applicable cleanroom performance parameters are measured after commissioning. Depending on the project scope, verification may cover airborne particle concentration, airflow, differential pressure, temperature, relative humidity and HEPA/FFU performance.
8. Documentation & Project Handover
Once testing and system adjustment are complete, SHP provides the agreed project documentation. Subject to the application and contract scope, documentation may include cleanroom drawings, equipment information, commissioning records, test reports, operation manuals and DQ/IQ/OQ/PQ documentation.
The final acceptance criteria are established on the basis of the approved engineering design, applicable standards and project-specific requirements.
Project Experience
Mauritius Pharmaceutical Cleanroom Project
Project Location:
Mauritius
Application:
Pharmaceutical Manufacturing
Scope of Work:
Design
HVAC
Installation
Validation
Cleanroom Classification:
ISO 7
Project Status:
Successfully Delivered
Cleanroom Testing & Verification
The performance of a cleanroom should be verified after installation and commissioning, in line with the applicable project requirements.
The cleanroom projects publicly documented by SHP include on-site inspection and performance verification of the installed systems. For the Romania turnkey project, this covered inspection of wall-panel sealing, doors and windows as well as particle-count and airflow measurements of the FFU/HEPA filtration system.
Typical Verification Items
Airborne Particle Count
Airflow Measurement
Differential Pressure
Temperature
Relative Humidity
HEPA/FFU Performance
Cleanroom Enclosure Integrity
Lighting and Other Environmental Parameters Where Required
Validation Documentation
Depending on the project scope, the cleanroom documentation can include:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Cleanroom Test Reports
Commissioning Records
Operation and Maintenance Documentation
Testing Evidence
Where project testing documentation is available, the relevant test reports and verification records can be provided as supporting project evidence.
The specific testing items, acceptance criteria and documentation are set according to the cleanroom classification, the application and the agreed project requirements.
Certifications
SHP works under a certified quality management system and manufactures cleanroom equipment in accordance with international standards for quality, safety and performance. Our engineering and manufacturing processes are continuously audited to ensure compliance with global cleanroom and HVAC project requirements.
Quality Management System
SHP is certified under ISO 9001:2015 Quality Management System standards, covering the design, manufacturing and installation of cleanroom systems, sandwich panels and air purification equipment.
Certificate: ISO 9001:2015 Quality Management System Certification
CE Certification for Cleanroom Equipment
To support international projects and regulatory compliance, the major cleanroom equipment supplied by SHP has been assessed for conformity with the applicable European directives on electrical safety and electromagnetic compatibility.
The CE-certified equipment includes:
Air Shower Room
Fan Filter Unit (FFU)
Pass Box
CE Certification for Air Shower Room
CE Certification for Fan Filter Unit (FFU)
CE Certification for Pass Box
Commitment to Quality and Compliance
Certified manufacturing processes, documented quality-control procedures and project validation services ensure that every SHP cleanroom and HVAC solution is delivered according to customer specifications, GMP requirements and international cleanroom standards.
Applicable Standards
ISO 14644 Cleanroom Standards
ISO 9001:2015 Quality Management System
EU Low Voltage Directive (2014/35/EU)
EU Electromagnetic Compatibility Directive (2014/30/EU)
GMP Guidelines for Pharmaceutical Manufacturing
EN1886 Air Handling Unit Standard
Company Profile
Established in 2003, SHP specializes in cleanroom engineering, manufacturing and purification systems. With more than 20 years of industry experience, SHP provides cleanroom design, manufacturing, installation, commissioning and technical support for pharmaceutical, biotechnology, medical, laboratory and electronics applications.
The product range covers modular cleanrooms, cleanroom panels, FFUs, HEPA filter boxes, air showers, pass boxes, AHUs, cleanroom doors and windows, together with related equipment.
SHP works within an ISO 9001:2015 quality management system and supports individual equipment supply as well as turnkey cleanroom projects. Based on the required cleanliness classification, process conditions, HVAC requirements and applicable standards, the engineering team provides project-specific solutions.
Related Cleanroom Products
Related Cleanroom Products
- Cleanroom Sandwich Panel
- Fan Filter Unit (FFU)
- HEPA Box
- Air Shower
- Pass Box
- Cleanroom Door
- AHU
