One Stop Custom Cleanroom Project Design Build GMP Compliance

Product Overview 

A customized cleanroom is a pollution-isolated controlled space built to meet specific industrial cleanliness and environmental demands. It uses high-quality sandwich panels, professional air handling units and efficient filter systems to control indoor particles, microorganisms and climate parameters accurately. It is essential for sectors like , electronics, food processing, hospital laboratories and precision instrument production. We provide full lifecycle cleanroom services from early design planning, construction execution, system debugging to standard testing and after-sales support. We can customize different cleanliness levels, sizes and functional layouts based on client’s site and production needs. Every project undergoes strict quality inspection to ensure stable purification performance, safety and durability. Our goal is to supply reliable turnkey cleanroom solutions for global customers and create a qualified controlled working environment.

Project Experience

Pharmaceutical Cleanroom Construction Project

Project Overview

SHP provided a turnkey cleanroom engineering solution for a pharmaceutical manufacturing facility, covering cleanroom partition systems, HVAC air distribution systems, cleanroom ceilings, lighting systems, and on-site installation services.

The project was designed and constructed in accordance with ISO 14644 cleanroom requirements to support controlled production environments and product quality assurance.

Construction Progress & Site Execution

HVAC Ductwork Installation

The HVAC duct system was installed according to the approved airflow design to ensure stable temperature, humidity, pressure differential, and air cleanliness levels within the cleanroom.

Installation of HVAC ductwork and ceiling support systems during cleanroom construction.

Cleanroom Corridor Completion

The cleanroom corridor section was completed with insulated sandwich panels, cleanroom doors, lighting fixtures, and service openings prepared for final commissioning.

Completed cleanroom corridor with wall panels, lighting system, and service access points.

Main Cleanroom Area Completion

The cleanroom production area was completed with modular wall panels, ceiling grid systems, and integrated utilities, preparing the facility for equipment installation and validation testing.

Main cleanroom area ready for equipment installation and system validation.

Scope of Supply

• Modular Cleanroom Wall Panels

• Cleanroom Ceiling System

• HVAC Air Duct System

• Cleanroom Doors & Windows

• LED Cleanroom Lighting

• Installation & Commissioning Support

Project Highlights

✔ Turnkey cleanroom engineering solution

✔ Professional HVAC installation

✔ Modular cleanroom panel construction

✔ ISO 14644 compliant design

✔ Pharmaceutical production environment

✔ Experienced on-site engineering team

Real Project Documentation

The photos shown above were taken during the actual construction process of a pharmaceutical cleanroom project completed by the SHP engineering team. The images demonstrate real installation work, HVAC system integration, cleanroom panel assembly, and project execution capabilities.

AVB Testing Report

Third-Party Performance Testing & Validation

To verify cleanroom performance and environmental control effectiveness, independent testing and validation were conducted after project completion.

Validation Services

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

Testing Items

• Airborne Particle Count Test
• Airflow Velocity Test
• Differential Pressure Test
• Temperature Test
• Humidity Test
• Illumination Test
• Noise Test

Third-Party Verification

The cleanroom system was tested and documented by an independent testing organization to verify compliance with project specifications and applicable cleanroom standards.

Certifications

SHP operates 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 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 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

 

Cleanroom Description

 

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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

 

Features at a Glance

 

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• Efficiently captures airborne dust, fine particulates and microorganisms to sustain superior, long-lasting indoor air cleanliness.
• Precisely regulates indoor temperature, humidity and pressure differentials to maintain a consistently stable controlled climate.
• Creates a fully enclosed protective barrier that isolates external pollutants and eliminates cross-contamination between functional zones.
• Incorporates professionally engineered airflow and balanced ventilation, delivering uniform cleanliness performance throughout the entire space.
• Fully adheres to international ISO and GMP standards, perfectly tailored for pharmaceutical, electronics, medical device and laboratory applications.
• Built with airtight insulated construction, intelligent energy-saving controls and antibacterial easy-clean materials for reliable long-term operation and minimal maintenance.

 

Cleanroom Applications

 

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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.

 

Integrated Cleanroom System Components

 

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Complete Cleanroom Material and Equipment Supply

In addition to cleanroom engineering services, SHP supplies the custom cleanroom panels, HVAC systems, filtration units, cleanroom doors and windows essential to turnkey cleanroom project delivery.

The following illustration presents the core systems and products supplied within SHP cleanroom projects.