For the more-than-minimally manipulated, also known as advanced therapies medicinal products, Regulations require these cell and gene therapy products to be manufactured in a cleanroom facility. Such facility provides an environment with controlled critical parameters like temperature, humidity, particle count, and pressure.

To build a cleanroom that meet the requirements, there are other important aspects to be considered as I discussed in an earlier post. In this post I will discuss the steps for cleanroom construction; these steps apply to both facility types, the modular and the brick-and-mortar cleanrooms.

Constructing a cleanroom facility is rather a complex process, but I’ll break it down to 3 major steps that make it achievable.

STEP I: Defining the requirements

In this stage, the scientist would define the required basics such as area, flow, no. of suits, and monitoring systems. Based on this draft, the construction company will generate a preliminary layout for the facility so the scientist can review to ensure the layout satisfies the intended purpose.

STEP II: Design

Once the preliminary layout is approved by the scientist, the construction company can move to designing the facility. This stage involves designing every aspect of the facility such as dimensions, pressure, air sampling ports, and electrical outlets. This stage result in comprehensive schematics that the scientist needs to review and approve.

STEP III: Construction

When the schematics are approved by the scientist, the construction company can start building the facility using the approved schematics. The building process is long, especially with the brick-and-mortar type. If the scientist later decided to make a design change, the project has to go back to step II.

Now, all this is exciting except for one thing, how would a scientist define the requirements, review, and approve the schematics?

Scientists know their process by heart, but constructing a cleanroom facility is not something they routinely do.

To successfully go through the different stages of constructing a cleanroom, scientists have few scenarios:

1. Scientist have expertise in cleanroom, and can navigate the process in conjunction with the expert of the construction company.
2. Hire a facility manager with expertise in cleanrooms to be on the scientist team, and help with the cleanroom project, and later be responsible for the cleanroom.
3. Hire a technical advisor to help the scientist with the different stages of the cleanroom project, until the task is completed.

We should note here the construction company experts are a very useful source of information, and they work well to clarify all aspects of cleanroom and their implication. However, the scientist needs a team member, or a third-party advisor to facilitate the design and review stages.

Due to the complexity of cleanroom construction process, it is best to start this process during product development, or even earlier, as I discuss in an earlier post.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us. 

About the author

Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here