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Pre Assembled Particle Controlled Clean Room Design With GMP Standard
| 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 Assembled Clean Room Design
,Particle Controlled Clean Room Design
,GMP Standard Clean Room Design
Pre‑Assembled Particle‑Controlled Cleanroom Modular Partition Structure for Industrial Fabrication Working Cell
Product Overview
Technical Reference Data
The reference information below outlines typical configurations for SHP cleanroom systems and related purification equipment. Actual cleanroom dimensions, airflow rates, filtration arrangement, pressure differential and environmental-control parameters are set according to the required cleanliness classification, the production process and 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 against 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
After installation and commissioning, applicable cleanroom performance parameters can be tested according to 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 data above is reference information rather than guaranteed parameters for every project. Final equipment selection and cleanroom performance criteria must 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
- Traps suspended particulates and dust pollutants, minimizing product malfunctions and improving overall manufacturing performance.
- Contains the spread of bacteria, fungi and spores, enabling compliant aseptic production and reducing material wastage.
- Offers accurate control of temperature, humidity and pressure gradients, keeping production insulated from outside environmental disruptions.
- Greatly lowers cross‑contamination risks throughout manufacturing workflows, raw materials and work‑in‑progress items.
- Utilizes integrated anti‑static setups to prevent high‑sensitivity precision components from electrostatic breakdown.
- Abides by GMP and relevant industrial standards to meet requirements for official certification and customer compliance evaluations.
- Ensures stable, replicable quality for all production batches, cutting additional expenses on reprocessing and product returns.
- Protects on‑site personnel from hazardous dust and aerosols while stopping harmful substances from diffusing outward.
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
Each SHP cleanroom project follows a structured engineering process, from initial requirement assessment through to installation, commissioning and performance verification. The specific scope and sequence are adjusted in line with the cleanroom classification, production process, facility conditions and project requirements.
1. Requirement Assessment
The engineering team reviews the intended application, required cleanliness classification, room functions, personnel and material flows, production equipment, environmental conditions and available utilities. These requirements form the basis for the cleanroom layout and system configuration.
2. Cleanroom Layout & Engineering Design
Working from the confirmed requirements, SHP develops 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 taken into account during system design.
3. Equipment & Component Selection
Cleanroom panels, FFUs, HEPA filtration units, AHUs, air showers, pass boxes, cleanroom doors and other components are selected in accordance with the approved technical requirements. Equipment specifications are reviewed to confirm compatibility with the overall cleanroom system.
4. Manufacturing & Quality Inspection
Cleanroom panels and related equipment are manufactured according to the approved specifications. Dimensions, materials, component configuration and other applicable quality-control points are checked before shipment. Manufacturing and inspection records can be provided according to the project documentation requirements.
5. On-Site Installation
The cleanroom enclosure, HVAC and filtration systems, electrical components and supporting equipment are installed in line with the approved layout. Panel joints, ceiling interfaces, doors, windows and service penetrations are sealed and inspected during installation.
6. Commissioning & System Adjustment
Following installation, the HVAC and purification systems are commissioned. Airflow distribution, pressure relationships and environmental-control settings are adjusted according to the project design and the required operating conditions.
7. Performance Testing & Verification
Applicable cleanroom performance parameters are measured after commissioning. Depending on the project scope, verification may include airborne particle concentration, airflow, differential pressure, temperature, relative humidity and HEPA/FFU performance.
8. Documentation & Project Handover
After testing and system adjustment, SHP delivers the agreed project documentation. Depending on 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 defined by the approved engineering design, applicable standards and project-specific requirements.
Project Experience
Mauritius Pharmaceutical Cleanroom Project
Location:
Mauritius
Application:
Pharmaceutical Manufacturing
Scope:
Design
HVAC
Installation
Validation
Cleanroom Classification:
ISO 7
Status:
Successfully Delivered
Cleanroom Testing & Verification
After installation and commissioning, cleanroom performance should be verified according to the applicable project requirements.
Publicly documented SHP cleanroom projects include on-site inspection and performance verification of the installed systems. In the Romania turnkey project, wall-panel sealing, doors and windows were inspected together with 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, 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, relevant test reports and verification records can be provided as supporting project evidence.
The testing items, acceptance criteria and documentation are determined by the cleanroom classification, the application and the agreed project requirements.
Certifications
SHP manufacturing is carried out under a certified quality management system in accordance with international standards for quality, safety and performance. Engineering and manufacturing processes are continuously audited to ensure compliance with global cleanroom and HVAC project requirements.
Quality Management System
SHP is certified to the ISO 9001:2015 Quality Management System standard, which covers 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, major cleanroom equipment supplied by SHP has been assessed for conformity with applicable European directives related to electrical safety and electromagnetic compatibility.
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
Through certified manufacturing processes, documented quality control procedures and project validation services, SHP ensures that every cleanroom and HVAC solution is delivered in accordance with 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
SHP was established in 2003 and specializes in cleanroom engineering, manufacturing and purification systems. With over 20 years of industry experience, the company provides design, manufacturing, installation, commissioning and technical support for cleanrooms serving pharmaceutical, biotechnology, medical, laboratory and electronics applications.
Products include modular cleanrooms, cleanroom panels, FFUs, HEPA filter boxes, air showers, pass boxes, AHUs, cleanroom doors and windows, as well as related equipment.
SHP operates under an ISO 9001:2015 quality management system and supports both individual equipment supply and turnkey cleanroom projects. Our engineering team provides project-specific solutions based on required cleanliness classification, process conditions, HVAC requirements and applicable standards.
Related Cleanroom Products
Related Cleanroom Products
- Cleanroom Sandwich Panel
- Fan Filter Unit (FFU)
- HEPA Box
- Air Shower
- Pass Box
- Cleanroom Door
- AHU
