Modular Cleanroom System with FFU HEPA Filter for Dust‑Free Production Workshop

Product Overview

Technical Reference Data

The following reference data describes standard configurations for SHP cleanroom systems and associated 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

FFU Reference Data

HEPA Box Reference Data

*Air volume and other operating parameters should be confirmed according to the selected equipment configuration and project design.

Cleanroom Environmental Control

Cleanroom Enclosure Materials

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 shown above serve as reference data rather than guaranteed parameters for each project. Final equipment selection and cleanroom performance criteria should be verified against the approved engineering design, the applicable standards and project-specific requirements.

Cleanroom Description

Cleanroom Core Functions

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 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 depend on 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

 

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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

 

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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

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Related Cleanroom Products

• Cleanroom Sandwich Panel
• Fan Filter Unit (FFU)
• HEPA Box
• Air Shower
• Pass Box
• Cleanroom Door
• AHU