Clean Room Installation: Implementation Steps from A to Z
16:47 - 01/03/2025 1442
Clean Room Installation: Implementation Steps from A to Z. A detailed guide from survey, design, construction to acceptance, helping businesses ensure the clean room meets GMP and ISO standards.
Is building a cheap cleanroom truly effective?
Cleanroom Air Control System
What does the clean room system consist of?
Clean Room Quality Monitoring and Inspection Process
Why is an A-Z Roadmap Necessary for Clean Room Installation?
In the industries of pharmaceuticals, healthcare, food, electronics, clean rooms are the key factor in ensuring product quality, safe production processes, and strict compliance with GMP, ISO 14644, HACCP. Lacking a clear roadmap in the design and installation of a clean room can lead to resource waste, increased costs, and prolonged timelines. Therefore, the process from survey, design, installation to acceptance and maintenance needs to be carried out in a systematic manner, ensuring optimal efficiency.
Additionally, with the need to optimize costs, choosing a cost-effective clean room is always a solution worth considering.
This article will provide an A-Z roadmap, helping investors, plant managers, and supervisory engineers gain a clear understanding of the steps to implement a compliant clean room, ensuring fast progress and sustainable efficiency.
Clean Room Implementation Steps
To fully understand the process, your business needs to master the clean room construction steps.
Survey & Needs Analysis
- Determine the type of clean room: Pharmaceutical clean room, healthcare clean room, food clean room, electronics clean room...
- Determine the cleanliness level: ISO 14644-1 Class 1 - 9, GMP, FDA...
- Survey the environment, sources of contamination, and specific requirements of the business.
Clean Room Design
- Draft layout drawings including space planning, airflow, HVAC system, lighting...
- Calculate pressure differentials, airflow direction, thermal load, while also implementing clean room pressure control.
- Select wall, floor, ceiling materials, and filtration equipment that are appropriate.
Construction & System Installation
- Construct the foundation, install wall, ceiling, and floor panels.
- Install doors, Pass Boxes, Air Showers, FFUs.
- Complete the installation of the electrical, air conditioning, and HVAC systems.
To ensure a professional implementation process, your business should also refer to the clean room construction process.
It is also important to choose the right clean room system components to ensure optimal performance.
Acceptance & Quality Inspection
- Inspect pressure, HEPA filtration, airflow speed, and particle count.
- Check vibration, noise level, temperature, and humidity.
- Accept based on ISO/GMP/FDA standards.
The monitoring process must comply with the Clean Room Quality Inspection standards.
Additionally, acceptance must also meet the clean room standards of the industry.
Maintenance and Operation
- Establish a regular maintenance schedule.
- Monitor the filtration performance, HVAC system, and air quality.
- Upgrade when there are changes in standards or production requirements.
Hải Dương Pharmaceutical Plant Project – HD Pharma
One of the exemplary projects implementing a systematic clean room installation process is the Hải Dương Pharmaceutical Plant – HD Pharma. During the implementation, this company adhered to the roadmap from survey to acceptance, delivering clear benefits:
✅ Saved 20% of the investment costs by choosing appropriate materials and HVAC systems.
✅ Ensured WHO GMP standards from the first inspection, without the need for adjustments.
✅ Shortened the construction timeline by 15%, enabling the plant to commence stable production quickly.
Project details: Hải Dương Pharmaceutical Plant – HD Pharma
Contact ANH KHANG CLEANROOM Now
If your business requires detailed consultation on the process of designing, constructing, and installing clean rooms, ANH KHANG CLEANROOM will be your trusted partner to implement the project efficiently, safely, and cost-effectively.
See more: Clean Room Design and Construction
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