What Are Clean Room Requirements? A Comprehensive Guide

2023-08-21

Introduction:

In the world of scientific research, maintaining a clean and organized environment is crucial for ensuring the accuracy and reliability of results. This is especially true in industries such as pharmaceuticals, biotechnology, and semiconductor manufacturing, where precision and cleanliness are paramount. The clean room, also known as a controlled atmosphere or Class 100 room, is an essential component of these facilities that provides a sterile environment free from contaminants and pollutants. In this blog post, we will explore the various requirements and considerations involved in creating and maintaining a clean room.

Section 1: Definition and Purpose of a Clean Room

A clean room is a specially designed space that is isolated from the outside environment to maintain a controlled level of cleanliness. It is typically constructed using materials that are highly resistant to contamination, such as stainless steel or glass, and is equipped with advanced air filtration systems to remove particles as small as 0.3 microns. The primary purpose of a laminar flow clean room is to create an environment that is free from dust, microorganisms, and other airborne particles that can interfere with the performance of sensitive equipment and experiments.

Section 2: The main characteristics of each ISO class

ISO Class	Maximum particles/m3	Air changes/hour	Typical applications
ISO 1	10 ≥0.1 µm<br>2 ≥0.2 µm<br>1 ≥0.3 µm<br>0 ≥0.5 µm	Not specified	Research labs
ISO 2	100 ≥0.1 µm<br>24 ≥0.2 µm<br>10 ≥0.3 µm<br>4 ≥0.5 µm	Not specified	Research labs
ISO 3	1,000 ≥0.1 µm<br>237 ≥0.2 µm<br>102 ≥0.3 µm<br>35 ≥0.5 µm	360 - 540	Pharmaceutical sterile filling
ISO 4	10,000 ≥0.1 µm<br>2,370 ≥0.2 µm<br>1,020 ≥0.3 µm<br>352 ≥0.5 µm	300 - 540	Pharmaceutical sterile filling
ISO 5	100,000 ≥0.1 µm<br>23,700 ≥0.2 µm<br>10,200 ≥0.3 µm<br>3,520 ≥0.5 µm<br>832 ≥1 µm<br>29 ≥5 µm	240 - 480	Pharmaceutical compounding
ISO 6	1,000,000 ≥0.1 µm<br>237,000 ≥0.2 µm<br>102,000 ≥0.3 µm<br>35,200 ≥0.5 µm<br>8,320 ≥1 µm<br>293 ≥5 µm	150 - 240	Pharmaceutical compounding
ISO 7	Not specified	60 - 90	Pharmaceutical packaging
ISO 8	Not specified	5 - 48	Pharmaceutical packaging
ISO 9	Not specified	<5	Ambient air

Section 3: Clean Room Design and Construction

The design and construction of a clean room must be carefully planned to ensure that it meets the specific requirements of the application. Some key factors to consider include:

a) Airflow Control: The air in a clean room must be circulated regularly to maintain the desired level of cleanliness. This requires the installation of advanced air filtration systems, such as HEPA filters or centrifugal fans.

b) Lighting: Clean rooms require bright lighting to allow workers to see their work clearly and to detect any signs of contamination. LED lights are often used due to their energy efficiency and long lifespan.

c) Temperature and Humidity Control: Both temperature and humidity must be carefully regulated within the clean room to ensure optimal performance of sensitive equipment and experiments. Temperature control may involve the use of heating or cooling systems, while humidity control may require the use of dehumidifiers or humidifiers.

d) Physical Barriers: To prevent contamination from entering the pharma clean room, physical barriers such as doors, walls, and ceilings should be installed using materials that are resistant to chemicals and other contaminants.

e) Cleaning and Maintenance: Regular cleaning and maintenance of the clean room are essential to maintain its effectiveness. This may involve daily vacuuming, wiping down surfaces, or more extensive cleaning procedures on a periodic basis.

Section 4: Personnel Training and Safety Protocols

To ensure the safe and effective operation of a clean room, all personnel working inside must receive proper training on the specific requirements and guidelines for maintaining cleanliness. This may include instructions on how to properly handle hazardous materials, how to wear personal protective equipment (PPE), and how to identify signs of contamination. Additionally, safety protocols should be established to minimize the risk of accidents or injuries during regular operations or emergency situations.

Conclusion:

Creating and maintaining a clean room is a complex process that requires careful planning, design, and execution. By following the requirements outlined in this guide, you can ensure that your clean room meets the highest standards for cleanliness and efficiency, allowing you to conduct sensitive experiments and produce reliable results. Whether you're working in pharmaceuticals, biotechnology, or other industries, a well-maintained clean room is an essential component of your facility's success.