Class 100 Ce Iso GMP Prefab Clean Rooms Cleanroom Supplies Rock Wool Sandwich Panel Hepa Filter

Product Overview 

According to ISO 14644-1, a cleanroom is "a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters (e.g., temperature, humidity, pressure) are controlled as necessary."

Cleanroom Description

Features at a Glance

Tier 1: Environmental Parameter Control
Function: Establish and maintain baseline physical constants

• • Air Purity Management: HEPA/ULPA filtration with real-time particulate monitoring

  • Thermodynamic Stability: Precision HVAC systems maintaining ±0.5°C temperature and ±5% RH humidity control

  • Pressure Differential Enforcement: Automated pressure cascades (15-30 Pa gradients between zones)

Tier 2: Contaminant Vector Management
Function: Intercept contamination at all transmission pathways

• • Aerodynamic Contamination Control: Unidirectional airflow at 0.45 m/s ±20% (ISO Class 5)

  • Surface-Borne Contaminant Mitigation: Non-shedding materials with cleanroom-grade surface finishes

  • Procedural Contamination Prevention: Gowning protocols with particle shedding limits (<10,000 particles/min for full suit)

Tier 3: Operational Process Control
Function: Standardize all interactions with the controlled environment

• • Material Flow Engineering: Three-stage airlock systems with interlocked doors

  • Personnel Contamination Control: Class-specific garment systems with validated donning procedures

  • Process Isolation: Modular cleanroom designs allowing separation of incompatible operations

Tier 4: Performance Verification Systems

• • Continuous Monitoring: Networked particle counters with 0.3μm and 0.5μm channels

  • Validation Protocols: ISO 14644-3 compliant testing (airflow uniformity, recovery testing)

  • Data Integrity Management: 21 CFR Part 11 compliant data logging and audit trails

Project

Project Execution Highlights

Cleanroom Construction Progress and On-Site Management

This project was executed by the SHP engineering team following a structured cleanroom construction process, including partition installation, ceiling grid assembly, HVAC ductwork integration, lighting installation, and final commissioning preparation.

Throughout the project, regular coordination meetings were conducted with the client and subcontractors to review progress, resolve technical issues, and ensure compliance with project specifications and cleanliness requirements.

The photos below show key stages of the cleanroom construction process and demonstrate SHP's capability in managing large-scale turnkey cleanroom projects.

Ceiling Grid Installation

The suspended ceiling support system was installed according to the cleanroom design layout. The ceiling grid provides structural support for cleanroom panels, FFUs, HEPA filters, lighting fixtures, and utility systems.

Scope:

• Modular ceiling suspension system

• Structural alignment and leveling

• Preparation for FFU and HEPA filter installation

• Utility routing coordination

HVAC Ductwork Installation

The HVAC air distribution system was installed to ensure controlled airflow, temperature stability, and pressure differentials required for cleanroom operation.

Scope:

• Supply and return air duct installation

• Airflow balancing preparation

• Integration with cleanroom ceiling system

• Compliance with cleanroom ventilation requirements

Client Coordination & Progress Review Meeting

Regular project meetings were conducted with the client, consultants, and engineering teams to monitor project milestones, discuss technical requirements, and coordinate installation activities.

Meeting Objectives:

• Construction progress review

• Technical issue resolution

• Installation schedule coordination

• Quality and safety management

• Preparation for commissioning and validation

Project Value Delivered

• Turnkey cleanroom engineering solution

• On-site project management support

• HVAC and cleanroom system integration

• International project execution experience

• Compliance with ISO 14644 cleanroom standards

Cleanroom Ceiling Grid Installation

Project Coordination Meeting With Client Team

HVAC Air Distribution System Installation

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

 

Company Profile

 

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About SHP Cleanroom Engineering

SHP is a professional cleanroom engineering company specializing in the design, manufacturing, installation and validation of cleanroom systems for pharmaceutical, biotechnology, medical device, laboratory and electronics industries.

With over 20 years of industry experience, SHP provides complete turnkey cleanroom solutions from concept design to project delivery.

Company Strength

Item	Data
Industry Experience	20+ Years
Completed Projects	2100+
Countries Served	40+
Senior Engineers	12
Quality Certification	ISO 9001:2015

Core Products

• Cleanroom Turnkey Projects
• Air Handling Units (AHUs)
• Fan Filter Units (FFUs)
• Air Showers
• Pass Boxes
• Cleanroom Panels
• Cleanroom Doors & Windows

Engineering Services

• Design & Consulting
• Manufacturing
• Installation
• Commissioning
• Validation (DQ / IQ / OQ / PQ)
• After-Sales Support

 

Our Customers

 

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Project Delivery & Export Documentation

 

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Cleanroom Project Material Delivery

The following images record the packaging, container loading and international shipment process of the cleanroom project delivered by SHP.

The shipment included rock wool sandwich panels, cleanroom doors, windows and related supplies prepared for overseas installation.

 

Frequently Asked Questions

 

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1. Can SHP provide both cleanroom materials and complete turnkey installation services?

Yes. SHP provides complete cleanroom project solutions including cleanroom design, rock wool sandwich panels, HVAC systems, HEPA filtration, cleanroom equipment, installation, commissioning, validation, and after-sales support. Customers can purchase individual cleanroom components or choose a complete turnkey engineering package.

 

2. How does SHP ensure the cleanroom achieves the required cleanliness level?

Cleanroom performance is verified through airflow testing, airborne particle counting, differential pressure testing, temperature and humidity testing, and other validation procedures. Independent third-party testing can also be arranged after project completion.

 

3. What industries commonly use this Class 100 cleanroom solution?

This cleanroom solution is widely used in pharmaceutical manufacturing, biotechnology, medical device production, laboratories, and electronics manufacturing facilities where airborne contamination control is critical.

 

4. Does SHP have experience with overseas cleanroom projects?

Yes. SHP has completed more than 2,100 projects and has provided cleanroom engineering services in over 40 countries. The company has extensive experience in project management, international shipping, installation coordination, and technical support for overseas customers.

 

5. What certifications support the quality of SHP cleanroom projects?

SHP operates under an ISO 9001:2015 certified quality management system. Major cleanroom equipment including Air Shower Rooms, Fan Filter Units (FFUs), and Pass Boxes are supplied with CE certifications. Projects are implemented according to ISO 14644 and GMP requirements.

 

6. What information should be provided to receive a cleanroom project proposal?

To prepare an engineering proposal, customers typically provide the required cleanroom classification, room dimensions, production process, industry application, temperature and humidity requirements, and project location. Based on these requirements, SHP can recommend a suitable cleanroom configuration and project scope.