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Chemical Resistant Hardwall Medical Device Manufacturing Clean Room Modular Enclosure
| 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 |
Hardwall Medical Device Manufacturing Clean Room
,Modular Medical Device Manufacturing Clean Room
,Chemical Resistant Medical Clean Room
Chemical-Resistant Hardwall Modular Cleanroom Enclosure with Specialized Surface Finish for Industrial Labs
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 configuration, pressure differential and environmental-control parameters are determined according to the required cleanliness classification, 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 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. Air Filtration
Without it: Every cubic meter of indoor air carries millions of submicron particles — invisible dust, skin flakes, soot, fiber fragments — any one of which can short a circuit, clog a nozzle, or contaminate a sterile fill. With it: Multi-stage HEPA/ULPA filtration scrubs the air to fewer than 3,520 particles ≥0.5μm per cubic meter at ISO Class 5, removing 99.997% of particulate threats before they reach the product.
2. Airflow Design
Without it: Particles hover and settle. A dead zone above the workbench becomes a dust reservoir. Contaminants generated by the operator or tool recirculate endlessly. With it: Laminar flow pushes a uniform column of clean air downward at 0.45 m/s, sweeping every particle into the return plenum before it can land. Turbulent dilution in lower-grade zones drives 20–60 air changes per hour to flush the space continuously.
3. Temperature & Humidity Control
Without it: A 2°C drift during photolithography shifts critical dimensions. A humidity spike causes hygroscopic powders to cake. Condensation forms on chilled surfaces, breeding microbes. With it: HVAC loops hold temperature to ±0.5°C and humidity to ±3% RH around the clock, neutralizing outdoor weather, equipment heat loads, and occupancy effects.
4. Pressure Cascading
Without it: Open a door, and unfiltered corridor air floods into the clean zone. Particles migrate freely across the facility. One breach in one room compromises the entire suite. With it: Positive pressure differentials of 5–15 Pa between zones force air to flow only one way — outward from clean to less clean. Even during door operations, dynamic VAV compensation restores the gradient in seconds.
5. Sealed Envelope
Without it: Gaps between wall panels collect dust that no filter can reach. Sharp corners trap debris. Ceiling penetrations leak unfiltered plenum air into the workspace. With it: Factory-laminated panels with flush, silicone-sealed joints. Rounded coves at every wall-to-floor transition. A 100% airtight shell that leaves no surface for dirt to grip.
6. ESD Protection
Without it: A technician walks across the floor, builds a 5,000-volt charge, and touches a fixture — the micro-discharge fries a batch of wafers worth tens of thousands of dollars. With it: Conductive flooring (10⁴–10⁹ Ω surface resistance), grounding straps, and humidity held above 35% RH drain static continuously. Charges can't build, so arcs can't happen.
7. Entry Gowning & Air Shower
Without it: An operator in street clothes carries millions of skin particles, fibers, and bacteria through the door. Within minutes, the cleanroom is as dirty as the hallway outside. With it: A staged protocol — coverall, hood, boots, gloves — followed by a 25 m/s air shower for 15–30 seconds, reduces the particle burden per person by over 90% before entry.
8. Environmental Monitoring
Without it: A filter develops a pinhole leak. A pressure differential collapses. Temperature overshoots by 3°C. Nobody knows until product fails downstream — and the root cause is unprovable because no data exists. With it: Real-time particle counters, pressure sensors, and T/RH probes stream to a BMS/EMS historian, flagging every deviation instantly and building an audit-ready record.
9. Energy Recovery
Without it: The HVAC system runs at full power 24/7, consuming 50–70% of total facility energy, driving operating costs into unsustainable territory. With it: Variable-speed fans throttle down during idle periods. Enthalpy wheels reclaim 60–80% of exhaust energy. The system delivers cleanliness at the lowest possible wattage.
10. Validation
Without it: Someone says "trust us, it's clean" — and the auditor disagrees, halting production, triggering a recall, or refusing market authorization. With it: IQ/OQ/PQ testing proves filter integrity, airflow uniformity, recovery time, and temperature mapping with documented, reproducible data. Certification is a file you can hand to any regulator with confidence.
The Bottom Line
A cleanroom is not a room that happens to be clean. It is an engineered system where ten interdependent functions work together in real time. Remove any one, and the whole chain fails. Keep all ten in spec, and your product never meets a particle it shouldn't.
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 actual scope and sequence are adjusted according to 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
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, 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 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, 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 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
