Why Maintaining the High Standards of a Cleanroom Can Be So Difficult

Cleanrooms are specialized environments that are designed to maintain a specific level of cleanliness and control of contaminants. 

These environments are used in a variety of industries, such as semiconductor manufacturing, pharmaceuticals, and medical research, where even the slightest amount of contamination can have disastrous consequences. 

Cleanrooms are used in a wide range of industries, such as semiconductors, pharmaceuticals, food production, and aerospace. Maintaining the high standards of a cleanroom can be incredibly difficult, and in today’s article, we are going to look at six reasons why this is so.

#1. Maintaining Proper Air Pressure 

Maintaining proper pressure differentials in a cleanroom is a critical aspect of ensuring the cleanliness and safety of the environment. A cleanroom is designed to have a higher pressure than the surrounding area, which helps to prevent contaminants from entering the room.

If there are leaks or gaps in the walls or doors, air from the outside can enter the room, compromising the pressure differential and allowing contaminants to enter. This is why workers need to regularly inspect and maintain the integrity of the cleanroom’s seals.

#2. Compliance and Regulations 

Cleanrooms are often subject to strict regulations and standards, which can be difficult to meet and maintain. This requires ongoing training and education for staff, as well as regular audits and inspections to ensure compliance.

Cleanrooms are classified and regulated according to cleanroom ISO standards, which are set by the International Organization for Standardization. The ISO 14644 series of standards defines the requirements for cleanrooms and clean zones and is widely recognized and used internationally.

The most commonly used standard for cleanrooms is ISO 14644-1, which defines the classification of air cleanliness and includes 9 classes, ranging from ISO 1 to ISO 9, with ISO 1 being the most stringent and ISO 9 being the most relaxed. 

#3. Environmental Stability

Cleanrooms are often kept at a specific humidity level, and even small variations in these conditions can cause problems. For example, if the humidity level becomes too high, it can cause condensation on surfaces and equipment, which can lead to contamination. 

Maintaining the proper temperature within the cleanroom is also important as it can affect the air pressure. If the temperature in the cleanroom is too high, the air will expand, causing the pressure to rise. This can cause leaks and make it harder to maintain the desired pressure differential.

#4. Human Presence

The presence of humans is another factor that affects cleanroom quality. This is due to the potential for contamination caused by personal protective equipment (PPE) worn by personnel. 

PPE such as gloves, lab coats, and shoe covers can trap particles and bacteria on their surface, which can then be introduced into the cleanroom environment if not properly cleaned or replaced. 

Cleanroom personnel may inadvertently introduce contaminants into the cleanroom through their skin, hair, or clothing if they are not adequately decontaminated before entering the cleanroom.

This is why cleanrooms often have strict protocols for gowning, which require people to wear special clothing and protective gear when entering the room.

#5. Cleaning and Maintainance

Even with the best air filtration systems and other equipment, cleanrooms still require regular cleaning and maintenance. These systems are designed to remove particles from the air and keep the air as clean as possible. However, they are not perfect and can be difficult to maintain.

Air filtration systems require regular cleaning and replacement of filters, as even a small amount of dust or debris on the filters can reduce their effectiveness.

The cost of maintenance also exists, which includes the cost of regular cleaning, replacement of filters and other equipment, and monitoring equipment for the continuous monitoring of the particle count, temperature, and humidity.

Cleanroom personnel need to be trained in proper protocols for decontamination, gowning, and handling of equipment and materials to avoid contamination, as hiring underqualified workers can lead to significant financial loss in the long term. 

The cost of staff training and education is also a major factor that adds to maintenance expenses.

#6 Cost of Construction 

Cleanrooms can be quite expensive to construct and maintain. The cost of a cleanroom depends on a variety of factors, including the size and complexity of the facility, the level of cleanliness required, and the type of equipment and materials used. 

One of the major costs associated with cleanrooms is the construction and design of the facility itself. This can include the cost of building materials, HVAC systems, and special flooring and ceilings required to maintain a controlled environment. 

Cleanrooms also require specialized equipment such as HEPA filters, laminar flow workstations, and air showers to maintain the necessary level of cleanliness.


Cleanrooms are an invaluable part of the production of several essential products and commodities in our everyday life. The standards that they are subject to are of the highest and provide consumers with the confidence and satisfaction that their products have been created according to the best standards.

It isn’t an easy process, though. These standards are rigorous, intensive, and quite expensive to maintain, leading to higher product costs that consumers have to deal with. However, it’s a tradeoff that many are willing to accept.