Laboratory Clean Room Function Clean Work Room CE/ISO Certificated GMP Cleanroom System

Product Overview

Cleanroom

Cleanrooms are controlled environments that restrict airborne contaminants and maintain stable environmental conditions, ensuring the quality and reliability of products like semiconductors, medical devices, and vaccines.

Cleanroom Description

Technical Reference Data

Cleanroom systems are engineered according to the cleanliness classification, room layout, process conditions and HVAC demands of the specific application.

The data below is derived from product specifications publicly published by SHP and should be treated as reference configurations rather than fixed specifications for each individual project.

HEPA Box Reference Specification

FFU Reference Specification

Cleanroom System Configuration

Note: The definitive equipment selection, dimensions, airflow, filtration level and environmental control parameters are set according to the project design and the required cleanroom classification.

Key Advantages of Cleanrooms

• A cleanroom’s rigorous environmental control system effectively eliminates airborne particulate and microbial contamination, thereby ensuring the integrity and reliability of high-precision components and sterile pharmaceutical products.
• By maintaining stable, repeatable environmental parameters (temperature, humidity, differential pressure, airflow velocity), cleanrooms provide a standardized operational baseline that enhances process reproducibility and reduces batch-to-batch variability.
• As a core compliance enabler, cleanrooms help enterprises meet stringent regulatory requirements of industries such as semiconductors, bio, and medical devices, facilitating market access and certification acquisition.
• The implementation of cleanroom facilities reduces product defect rates and rework frequency, which in turn optimizes material utilization efficiency and lowers overall production costs.
• Cleanrooms serve as a critical infrastructure for cutting-edge research and advanced manufacturing, supporting the development of next-generation technologies including microelectronics, gene therapies, and aerospace components.
• Custom-designed cleanroom pressure systems (positive/negative) prevent the leakage of hazardous substances or cross-contamination, offering dual protection for on-site personnel and the external environment.

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 carries out its cleanroom projects through an integrated engineering process that covers design, manufacturing, installation, commissioning and performance verification.

1. Requirement Assessment

The project starts with an assessment of the customer's production process, required cleanliness classification, room functions, personnel and material flow, environmental conditions and supporting utilities.

2. Cleanroom Layout & System Design

Based on the project requirements, the engineering team develops the cleanroom layout and coordinates the enclosure structure, HVAC system, air distribution, filtration, electrical systems, doors, windows and supporting cleanroom equipment.

3. Equipment & Component Manufacturing

Cleanroom panels and related equipment are manufactured according to the approved project requirements. SHP's product range includes cleanroom panels, AHUs, FFUs, HEPA boxes, air showers, pass boxes, clean benches, cleanroom doors and windows.

4. On-Site Installation

The cleanroom enclosure, HVAC system, filtration equipment, electrical systems and supporting components are installed and coordinated on site. Wall and ceiling joints, penetrations and equipment interfaces are sealed and inspected as part of the cleanroom construction process.

5. Commissioning & System Adjustment

After installation, HVAC and filtration systems are commissioned and operating conditions are adjusted according to the project requirements. Airflow, pressure relationships and environmental parameters are checked before final testing.

6. Cleanroom Performance Testing

Applicable cleanroom performance parameters are tested according to the agreed project requirements. Testing may include airborne particle concentration, airflow, differential pressure, temperature, humidity and other environmental parameters.

7. Validation & Project Handover

Where included in the project scope, SHP can provide DQ, IQ, OQ and PQ documentation together with testing records, operation manuals, maintenance information and cleanroom drawings.

The final acceptance criteria and documentation depend on the cleanroom classification, application and contractual project requirements.

Project Experience

1.Mauritius National Cleanroom Project – Medical Device Manufacturing

SHP has publicly documented its involvement in a national cleanroom project in Mauritius for medical appliance production and sterilization.

The project focused on establishing an ISO-certified controlled environment for medical-device-related manufacturing processes. SHP provided purification engineering solutions including HEPA filtration, environmental control for temperature and humidity, airborne particle control and cleanroom validation procedures.

Project Application: Medical Device Manufacturing

Location: Mauritius

Project Scope: Cleanroom purification system, HEPA filtration, environmental control and validation

Cleanroom Requirement: ISO-certified controlled environment

This project demonstrates SHP's experience in delivering controlled-environment solutions for contamination-sensitive medical manufacturing applications.

2.Bangladesh Electronics Cleanroom Project

SHP has also publicly documented the successful completion and handover of a cleanroom installation for an electronics manufacturer in Bangladesh.

The project was designed to meet ISO Class 7 (10,000) requirements and was developed for the production of sensitive electronic components.

Project Application: Electronics Manufacturing

Location: Bangladesh

Cleanroom Classification: ISO Class 7 (10,000)

Project Type: Electronics Manufacturing Cleanroom

The project provides a reference for cleanroom applications where airborne particle control and a stable manufacturing environment are important.

3.Romania Turnkey Cleanroom Project

In Romania, SHP completed a turnkey cleanroom project covering design, fabrication, installation and commissioning. The publicly documented project included modular cleanroom wall and ceiling panels, seamless coved epoxy flooring, ceiling-mounted FFU arrays with HEPA filtration, LED lighting and cleanroom doors with vision panels.

Following installation, SHP engineers conducted on-site inspection and cleanroom performance verification, including particle counting and airflow measurements for the FFU/HEPA filtration system.

Project Location: Romania

Application: Pharmaceutical and microbiological applications

Project Type: Turnkey Cleanroom Engineering

Scope: Design, fabrication, equipment supply, installation, commissioning and cleanroom performance verification

The project was completed and handed over after the documented inspection and validation process.

Cleanroom Testing & Verification

After installation and commissioning, cleanroom performance should be verified according to the applicable project requirements.

SHP's publicly documented cleanroom projects include on-site inspection and performance verification of the installed cleanroom systems; the Romania turnkey project, for instance, included inspection of wall-panel sealing, doors and windows together with particle-count and airflow measurements for 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 set according to the cleanroom classification, application and agreed project requirements.

 

Related Products

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Company Profile

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SHP, established in 2003, is a cleanroom engineering and manufacturing company specializing in cleanroom systems, HVAC integration, cleanroom panels, doors and windows, FFUs, air showers and other cleanroom equipment.

 

The company provides services covering design, manufacturing, installation, commissioning and technical support for pharmaceutical, biotechnology, medical device, laboratory and electronics applications. Under an ISO 9001:2015 quality management system, SHP supports both equipment supply and turnkey cleanroom engineering projects in accordance with customer specifications and applicable industry requirements.

 

With more than 20 years of experience in the industry, SHP has been involved in cleanroom projects in both domestic and international markets and continues to support customers through engineering, manufacturing and project implementation services.

 

Our Certification

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Packing and Shipping

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FAQ

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Q1: Where is your company?

A1:Our company is located in Suzhou City, close to Shanghai. It's a 1.5-hour drive from PVG Airport.

Q2: Are you a manufacturer or a trading company? What can I buy from you?
A2: We are manufacturers. We focus on cleanroom projects, air showers, FFUs, through boxes, dosing rooms, laminar flow hoods and benches, AHUs, and sealed doors and Windows. 

Q3:When is your delivery time? 
A3: If your cleanroom project includes AHU, the delivery time is 35 days. If you purchase goods without an AHU, the delivery time is 10 days. 

Q4: How long is your warranty period? What kind of after-sales service can you offer?
A4: Our warranty period is two years after the completion of the project. During the warranty period, if there are any problems, we will replace it. If you can't handle it, we will send an engineer to solve it for free.

Q5:Can you conduct cleanroom validation? 
A5: Yes, we can offer documentaries of DQ, IQ, OQ and PQ. Still fat & Sitting. Product operation manual, maintenance guide and a complete set of cleanroom drawings. 

Q6:What are your advantages?
A6: We have a complete technical team consisting of 12 senior cleanroom and HVAC engineers to provide you with technical support. We have completed over 2,100 cleanroom projects in China and overseas. Such as Japan, Indonesia, Thailand, Bangladesh, India, North Macedonia, Saudi Arabia, Yemen, Russia, Moldova, Switzerland, Norway, the United Kingdom, Spain, France, Belgium, Kuwait, Tunisia, Mauritius, Sri Lanka, Mongolia, Philippines, Nepal, Sudan, Somaliland, Australia, New Zealand, Canada, Algeria, Egypt, Singapore, and the United States.