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Modular Medical Clean Room On Site Assembled For Pharmaceutical Processing
| 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 |
modular Medical Clean Room
,on site assembled Medical Clean Room
,modular clean room for pharmaceutical processing
On‑Site Assembled Industrial Cleanroom Contamination Control Enclosure Tailored for Electronics Fabrication Lines
Product Overview
Technical Reference Data
The following reference data describes standard configurations for SHP cleanroom systems and associated 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 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 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
- Intercepts suspended particulates and airborne dust to curb product failures and optimize overall manufacturing output.
- Restrains microbial propagation of bacteria, fungi and spores to enable compliant aseptic manufacturing and reduce material waste.
- Maintains precise control over temperature, humidity and pressure gradients, shielding production activities from external environmental interferences.
- Significantly mitigates cross‑contamination risks among production workflows, raw feedstocks and work‑in‑progress parts.
- Equipped with integrated anti‑static systems to safeguard high‑sensitivity precision components against electrostatic failure.
- Complies with GMP and corresponding industrial standards for official certification and customer compliance audits.
- Guarantees consistent, replicable quality across production batches, reducing extra expenditures on rework and product returns.
- Safeguards on‑site operators against hazardous dust and aerosols and restricts outward diffusion of harmful agents.
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 delivers its cleanroom projects through a structured engineering process covering initial requirement assessment, 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 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
Cleanroom performance should be checked after installation and commissioning, in accordance with the applicable project requirements.
SHP's publicly documented cleanroom projects include on-site inspection and performance verification of the installed systems. The Romania turnkey project, for example, involved inspection of wall-panel sealing, doors and windows 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, 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 testing items, acceptance criteria and documentation depend on the cleanroom classification, the application and the agreed project requirements.
Certifications
SHP works within a certified quality management system and produces cleanroom equipment according to international standards for quality, safety and performance. Its engineering and manufacturing processes are continuously audited for compliance with global cleanroom and HVAC project requirements.
Quality Management System
SHP is certified to 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
Through certified manufacturing processes, documented quality-control procedures and project validation services, SHP ensures that each cleanroom and HVAC solution is delivered in line 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
Since 2003, SHP has specialized in cleanroom engineering, manufacturing and purification systems. With more than two decades of industry experience, SHP offers cleanroom design, manufacturing, installation, commissioning and technical support for pharmaceutical, biotechnology, medical, laboratory and electronics applications.
Our product range includes modular cleanrooms, cleanroom panels, FFUs, HEPA filter boxes, air showers, pass boxes, AHUs, cleanroom doors and windows, and related equipment.
The company operates under an ISO 9001:2015 quality management system and supports both individual equipment supply and turnkey cleanroom projects. SHP's engineering team develops project-specific solutions based on the 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
