Cleanroom Design and Installation

A cleanroom is a specially designed controlled environment with extremely low levels of airborne particles, microorganisms, dust, and aerosols. It is essential in industries such as pharmaceuticals, electronics, and biotechnology to ensure product quality and research integrity by maintaining cleanliness levels according to international standards such as ISO.

Cleanroom Design

Cleanroom design aims to create an environment with controlled air quality, pressure, and cleanliness to ensure safe pharmaceutical production free from contamination.

Initial Design Phase

• Requirements analysis: determining room classification (ISO 5–ISO 8 or Grade A–D according to GMP/CPOB standards)

• Workflow study: separating material flow, personnel flow, and waste flow to prevent cross-contamination

• Layout design: arranging production rooms, airlocks, technical rooms, and supporting areas

Key Design Elements

1. Wall & Ceiling Structure

   • Made of sandwich panels (EPS, PU, or rockwool) with smooth, chemical-resistant, and easy-to-clean surfaces

2. Cleanroom Flooring

   • Epoxy or anti-static vinyl flooring to prevent dust accumulation

3. Doors & Windows

   • Interlocking doors with control systems to maintain air pressure

   • Flush windows with flat surfaces to prevent dust accumulation

4. HVAC & HEPA Filters

   • HVAC systems maintain stable pressure, temperature, and humidity

   • HEPA filters installed at air supply points to ensure air quality compliance

5. Differential Pressure

   • Positive pressure in critical areas to prevent particle ingress

6. Lighting & Electrical Systems

   • LED lighting with appropriate intensity for clean environments and easy maintenance

Design Documentation

• 2D & 3D cleanroom layouts

• User Requirement Specification (URS).

• P&ID (Piping and Instrumentation Diagram) for supporting systems
  
  

Cleanroom Installation

After design approval, installation is carried out through the following stages:

- Civil Works & Preparation

• Cleaning of the work area and installation of structural frames for walls, ceilings, and flooring

• Installation of utility lines (electricity, HVAC, water pipes, gas, and automation systems)

- Wall & Ceiling Installation

• Wall panels installed according to layout using silicone sealant to prevent air leakage

• Cleanroom ceilings installed to support HEPA filters, lighting, and air diffusers

- Flooring & Accessories Installation

• Epoxy or vinyl flooring installed with minimal joints to prevent dirt accumulation

• Installation of interlock doors, pass boxes, and flush windows as per design

- HVAC & Control System Installation

• Integration of HEPA filters, ducting, and AHU systems to maintain air quality

• Monitoring systems for temperature, humidity, and air pressure connected to SCADA/BMS
  
  

Qualification & Validation Testing

Before the cleanroom is put into operation, the following tests are conducted:

• Installation Qualification (IQ) : verifying installation according to design

• Operational Qualification (OQ) : ensuring all systems function correctly

• Performance Qualification (PQ) : testing actual operating conditions