For those of you who work in the biomedical industry, cleanrooms are an essential part of your day-to-day lives. They’re also a big part of any manufacturing project. But if you’re new to this environment or have never worked with a cleanroom, it can be challenging to know where to start when planning one out.
Fortunately, plenty of online resources can help guide you through the process. Here’s a handy guide to help you get started.
Start by Defining Your Needs
Before you can start planning a cleanroom, you need to understand what a cleanroom is. A cleanroom is any room designed, built, and/or equipped to maintain a controlled environment.
Cleanrooms are used in many different industries, such as semiconductor manufacturing, pharmaceutical processing, aerospace and defense manufacturing, food processing and packaging, etc.
Some of the key reasons why these companies use cleanrooms include:
- Protecting sensitive equipment from contamination
- Controlling contamination levels to prevent cross-contamination between products
- Maintaining a safe working environment for employees with respiratory or other illnesses who require specific air quality requirements
- Reducing airborne particulate levels as low as possible for better product performance
The first thing you need to do here is defining how clean you want your cleanroom. There are 9 different cleanroom classifications in the ISO 14644-1 standard alone. The different levels require different control over the environment.
For example, ISO 9 cleanrooms allow 35,200,000 particles > 0.5 microns per cubic meter. On the other hand, ISO 1 allows 0, and ISO 2 allows only 4 particles > 0.5 microns per cubic meter, respectively.
You can define your needs here and understand how clean your cleanroom’s environment should be. This will help you have a clear goal in mind.
Do You Want Your Cleanroom Portable or Fixed-In-Place?
There are two main types of cleanrooms, portable and fixed-in-place.
- Portable: A portable cleanroom can be moved to different locations to suit your needs. Since it’s movable, this option is more flexible than the fixed-in-place version. But it also comes with added expenses and complexities. Consider the cost of moving your cleanroom if you’re looking at this type. A fixed model may be better suited if portable isn’t feasible.
- Fixed: A fixed cleanroom offers a permanent location that won’t have to be moved or dismantled when not in use. This option tends to be cheaper in terms of both initial price and maintenance costs over time because there aren’t any additional costs associated with moving the system around.
However, this type requires more space than a portable model does. If you don’t have enough room to install the unit, this might not work out well.
The choice here again depends on your requirements. The biggest challenge with portable cleanrooms is the associated cost. However, you can work on developing mini portable cleanrooms to address the costs if the number of products you want to manufacture is limited.
For example, a group of researchers successfully created a mini cleanroom for manufacturing advanced therapy medicinal products. Although essential, the problem with therapeutic medicinal products is that their use is limited to a few patients. Hence, the researchers created mini cleanrooms to overcome the cost issues and published their work in an article on the NCBI website.
Choose the Type of Cleanroom You Want
In general, there are different types of cleanrooms. These can vary from modular cleanrooms to hybrid cleanrooms and medical device cleanrooms to mask manufacturing cleanrooms. Hence, choosing the type of cleanroom you will need is vital to get the job done.
Here are some types of cleanrooms you should know about:
- Modular cleanrooms: Modular cleanrooms are built with prefabricated components assembled on-site. Thus, they are portable cleanrooms that can be installed 50% faster than standard cleanrooms. Hence, the modular cleanroom solutions market is growing, expected to reach $837.6 million in 2028.
- Hybrid cleanrooms: As the name gives out, hybrid cleanrooms combine modular and conventional cleanrooms. They are built using modular components but within fixed walls, like conventional cleanrooms.
- Softwall cleanrooms: Softwall cleanrooms are built by hanging vinyl sheets or curtains on a frame to impersonate walls.
- Medical device cleanrooms: These cleanrooms are specifically designed to facilitate medical device manufacturing.
- Pharmaceutical cleanrooms: The pharmaceutical cleanrooms are designed for manufacturing pharma drugs. They are designed to provide a controlled environment according to the FDA (Food and Drug Administration) validation for manufacturing your drug.
- Laser cleanrooms: Laser cleanrooms are specifically designed to facilitate laser-based experiments. They have blackout curtains to prevent light from entering them.
How Much Airflow Will You Need to Maintain Rigorous Cleanliness Standards?
As you may have guessed, the amount of airflow required depends on the level of cleanliness required. For example, if you’re trying to achieve a Class 100 environment, meaning that all particles should be removed, you will need much more airflow than if you were working toward an ISO 5 Class 10 rating, which still requires very high standards.
The same principle applies when considering particulate matter like dust and dirt. The higher the particle count in your air supply, the more air will be needed for removal. Because of this relationship between cleanliness level and the airflow needed, it makes sense to keep your filter system running at all times. If not 24/7, run the filters at least whenever work is performed in your cleanroom.
This way, as soon as someone introduces something into the room that compromises its sterile status, additional filtration will be provided automatically through an automated system without needing anyone’s help or oversight. High-Efficiency Particle Arresting (HEPA) filters can be used for this purpose. According to the Environmental Protection Agency (EPA), HEPA filters can help remove 99.7% of particles from cleanrooms.
Do You Need to Control Temperature and Humidity?
Humidity is important for cleanroom environments because it affects the growth of microbes. When there is too much water in the air, it becomes easier for bacteria and other microorganisms to grow.
To control humidity in a clean room, you can use a dehumidifier or air conditioner to remove moisture from the air. Using these devices helps keep contaminants at bay while keeping equipment functioning properly without damaging its components by drying them out too quickly.
Suppose you don’t control humidity levels appropriately in your clean room. In that case, this can cause problems with the product quality or even safety issues if any contaminated materials are present during manufacturing or testing processes that require precision accuracy over long periods.
Controlling humidity also gives workers who spend all day inside these environments more comfort throughout their shifts, reducing fatigue levels during work hours.
If you’ve made it this far, congratulations. You now know more about cleanrooms than most people do. But you can go further. Try reading more content about cleanrooms or watching YouTube videos. Once you have the right understanding of how cleanrooms work, it will become easier for you to design them based on your needs.