cleanroom approach

The Most Suitable Cleanroom Construction Approach For Your Facility

Cleanroom Construction Approach

When designing a new cleanroom—be it for USP compliance or to improve compounding efficiency—one of the first decisions is whether to install a modular design or the more traditional stick-built compounding facility. Historically, over 90% of the cleanrooms worldwide utilize the stick-built approach. The traditional stick-built method has been the golden standard for many years now. Many facility managers consider this to be a solution destined for the long haul, but due to the constant regulatory requirements, facilities are often facing constant compliance-related renovations and expenses.

The modular cleanroom model has been seen as a more temporary solution, but they are as sturdy and robust as the stick-built facilities. At first glance, the standard stick-built approach may appear more cost-effective over the prefabricated modular units. However, once customization due to regulatory requirements comes into play, the total cost between the two methods takes a huge swing in favor of the modular cleanroom approach. One important fact is that due to economies of scale, the larger the room, the lower the cost per square foot will be if you are gunning for the stick-built approach. The modular units have roughly the same cost per square foot, regardless of the size of the project. The stick-built or a hybrid model is the most reasonable option for facilities with large and supersized cleanroom spaces. While facilities that have some spacial constraints and need to squeeze a complete compliant cleanroom into a small space, the modular approach is the recommended approach.

Each sterile compounding facility project presents unique design challenges. Even though every project is unique, all facilities are faced with these common considerations, including project budget, current facility conditions and desired regulatory compliance. It is important to have a complete understanding of the different construction options before committing to a final design.

While initial construction and installation costs are primary concerns when building a cleanroom, another item to consider is the cost of maintaining and repairing the physical structure after installation. Bear in mind the economies of scale, meaning that if you are going to do some small-scale renovations on a stick-built cleanroom for compliance-related adjustments, you will be looking at a large bill due to the fact of the smaller the project, the bigger the price per square feet. This is a nonissue with the modular cleanrooms as the expansion or replacement parts have a more or less flat value that is irrelevant to the project scope.

Pros & Cons of the Stick-Built Cleanroom

One of the pros that were mentioned in this article earlier is the cost per square foot, meaning if you are building a big cleanroom, it is more cost-savvy to opt in for a Stick-Built cleanroom. In addition, the construction costs can be spread over the time frame of the construction process.

Where do we start on the cons; Let’s start with compliance. The quality of the Cleanroom relies primarily on field construction rather than the factory-controlled conditions used for fabricating modular systems. You don’t want to build a cleanroom that won’t stand compliant due to construction-related factors. While the Stick-Built Cleanroom has been seen as the long-run approach, we’ve encountered a number of facilities where we found that the paper-based wallboard provides the necessary medium for fungal growth, such as mold, even if mold-resistant products were specified.

The biggest setback with the Stick-Built approach is related to the expansion of the current facility which cannot be done without going offline. This can significantly impact pharmacy operations.

Pros & Cons of the Modular Design

The typical prefabricated modular units are freestanding and self-supporting with integrated HVAC and environmental systems, and are often delivered as plug and play solutions. Often, modular cleanrooms are delivered as freestanding, independent and standalone units that require very little to none on-site preparations. Because of that, the construction and installation cycles are typically shortened, which reduces onsite intrusions and disruptions.

The most noteworthy cons of the Modular approach include the longer lead times that are typically required for the build, as the required materials must be designed and fabricated off-site. Because of the fact that the unit is completely made in-house and only installed on-site, typically requires a significant upfront capital investment to place an order.

 

In the past few years, we’ve found ourselves suggesting modular cleanroom approaches to our clients more often than the stick build approach. Traditional stick-built facilities will need preventative maintenance and damage mitigation which translates to having the cleanroom go offline while undergoing renovation. The modular cleanroom can be renovated or even expanded with a few hours of downtime including current panel removal, installation of new components, and cleanroom cleaning. With the constant improvement of the  USP <797> and USP <800> standards for 503A facilities, or FDA cGMP regulations for 503B facilities, we are confident that the modular approach is by far the best option that allows your facility to scale in order to stay compliant with the desired regulation.

When we’re doing the initial assessment we talk extensively with our clients. This leads to the decision of whether if it would make sense for the client to put their current equipment in the new cleanroom. One of the things that set us apart from all of the others, is our dedication to work with the equipment you currently have over having our clients double spend on something that they already have in stock. We do a checkup to verify if that piece of equipment is still running at spec. We also check if the equipment would hold compliant with the regulation that the cleanroom is trying to meet.

 

Let us know if this is something you’d like to discuss with our team. You can also check our standard and customiseable MCC product page to learn more about our market-leading mobile cleanroom solution.

 

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