Upgrading Existing Pharmaceutical Cleanrooms: What You Need to Know

As the popular Greek proverb by Heraclitus says, “There is nothing permanent except change.” Although your pharmaceutical cleanroom conditions are designed to remain the same, your work rarely does.

Pharmacy is a field that evolves, you will find yourself required to meet new aseptic room requirements. Even jumping to a more stringent ISO room can be considered a big win for your facility. So how can you make this happen? This article will walk you through how you can upgrade your pharmaceutical classroom including where the process usually begins.

Upgrading Your Cleanroom Classification?

When you are required to move to a more stringent qualification. Taking a hard look at your cleanroom classification is the first thing you should do. Begin by looking at the current condition of your classroom and check the specific areas that need adjustment.

This will allow you to reach the highest level of cleanliness. Now to make things easier, let’s break down what’s in the classification. The three areas that you will be required to make great changes in are particles allowed by number and size, air changes per hour or airflow velocity, and percentage of ceiling coverage filter fan units.

Aside from ISO standards, your aseptic room upgrade must also reflect the changes based on your new project or scope of work. Consider what you want to start and the purpose of upgrading to ensure the success of future work. This can be more control over temperature and humidity, more space for equipment, cabinetry and other storage, furniture, lighting, and many more.

Redesigning Your Cleanroom

There are many factors to consider when redesigning space regardless of whether you are doing it to meet new aseptic room requirements or match a new purpose. The upgrade usually includes the layout and structure of the space, the system, and how you are going to maintain it once it’s done.

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Reconfiguring Your Layout

Depending on how you want your new project, you can rearrange modular panels to create a new look and shape that will suit your new projects. If you want a larger classroom, add more panels while for controlled and condensed space, remove and store extras. If you are planning to add other personnel, large equipment, or more carts to transport equipment, you will require more space. Therefore, make sure you factor in all these potential requirements when redesigning.

If you are upgrading to more stringent classifications or your project parameters are changing, you may need to select different requirements at the same time. Here are some suggestions for three different classroom types you can consider.

• Hardwall cleanroom: This provides more security and the highest control level. It will meet even the strictest classification standards.

• Softwall cleanroom: This offers flexibility, it’s easy to expand, reconfigure, and fit in smaller spaces. It’s an affordable option that provides room for growth.

• Rigidwall cleanroom: It’s less flexible compared to hardwalls but more stable than softwalls. It’s a minimalist middle brown made from solar clear panels, great for showing your operations to outsiders.

Meeting New Cleanroom Filtration Requirements

The new cleanroom classification will specify the number of particles allowed and the minimum air changes required to clean the air effectively. During the upgrade process, you will need to increase the air change rate and capture more and smaller particles. To achieve this, consider adding more fan filter units to increase the ceiling coverage percentage. This might also be the right time to check or replace the HEPA filters to ensure there is enough quality air circulation and removal of particles from the air.

Furthermore, it’s important to rearrange your layout or furniture by using a new airflow pattern. Furniture or equipment can block filters and interrupt air flow, resulting in pockets of turbulent air in pharmaceutical cleanrooms that can trap contaminants. To find the ideal airflow pattern that will work with your upgraded cleanroom consider working with a design expert who will use computational fluid dynamics to model the space airflow pattern and make the right decision regarding the layout that will enhance the air efficiency and support the HEPA filters healthy life.

Having proper airflow using an effective filtration system will help eliminate particles consistently and allow you to reach the appropriate level and all you need to do is to keep it there.

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Conclusion

While upgrading your existing pharmaceutical cleanroom is a nice journey, there are certain factors you should keep in mind which will help during the process. When redesigning the aseptic room, you have to consider factors like the layout and structure of the space, the system, and how you are going to maintain it once it’s done. Also, you have to ensure that it meets the specific filtration requirements.