For many of our clients, the first step in any cleanroom design project appears to be the most difficult one for them to wrap their mind around, namely: where do I begin? The number of decisions you need to make is often staggering.
However, I am here to tell you why that shouldn’t be your first question, and how my colleagues and I helped one company overcome this hurdle.
At a recent INTERPHEX, we met with a potential customer who applies gene therapy techniques to treat orphan diseases—diseases that are terribly harmful yet affect so few people that most companies wouldn’t try to develop treatments. Until recently, they relied on CMOs (contract manufacturing organizations) to produce their therapies. As they grew, they knew they would need to move manufacturing in-house.
As they explained to me, their expertise is in gene therapy design—not cleanroom design. That’s OK, I said, this is where we come in.
Let AES Compass Be Your Guide
First steps are the most daunting, which is why we developed our Compass program, a step-by-step cleanroom facility program that analyzes an organization’s current needs, existing infrastructure, and plans for growth. Compass will take you from ideation to turnkey design.
With Compass, we work with clients up front to identify their goals through a series of impactful cleanroom design and technology questions. We explore their processes and equipment needs. We develop the scope, costs, and schedule for their product. We look at the workflow through the facility–people flow, process flow and material flow. We engage experts in quality, manufacturing, and safety. We answer questions about manufacturing they didn’t know they have—from startup to scaling to meet future demand.
We looked at our new customer’s intended manufacturing space and determined how to mitigate innate structural limitations to allow for full mechanical systems and chiller plants to support their needs.
At the end, Compass delivers an exhaustive conceptual design report, which many clients take directly to the regulatory agencies.
All throughout, Compass is cleanroom neutral, in a manner of speaking, with the customer making the ultimate choice about which cleanroom manufacturer will provide for their needs. Compass merely provides the roadmap to FDA validation.
In this case, our customer narrowed their selection to two manufacturers: a prefabricated trailer-based design versus the AES Clean Technology modular cleanroom build. In the end, they chose our Faciliflex modular cleanroom design based on cost and ease of integration.
Building a Jewel of a Cleanroom
We provided a full turnkey effort, from design through construction. We certified and balanced the environment to ensure it performed to design intent (utilizing a third party to check and validate) and developed the documentation that our customer could then roll into commissioning.
The result was a seamless cleanroom product turned over to our client, who could then immediately begin validation and startup. On schedule and on budget.
It is, I say with no small amount of pride, a beautiful cleanroom facility, which included many of our more recent cleanroom technology innovations, such as:
AES Infinity Glass—our full glass wall system for exceptional visibility. Rocket wanted the facility to also serve as a showroom for investors. Our Infinity Wall system provides investors with the ability to get an up-close look at manufacturing, while still preserving the integrity of the cleanroom.
AES Lightbeam—our LED linear lighting system. Lightbeam incorporates LED lighting directly into a Marquee Walkable Ceiling, saving installation time, maintaining cleanroom integrity and providing a more stable ceiling product.
AES Omni Utility Raceway—pre-installed piping and valve systems for cleanroom gasses. This is a game-changing product that isn’t quite visible, by design. With Omni, everything for air and gasses is built directly into the modular walls, allowing for fast, clean installation and added security. All of the connections are made above the ceiling.
One Interface, from Conception to Turnover
Our customer’s new cleanroom build is just one example of how our experts at AES Clean Technology can help you get manufacturing off the ground rapidly while staying in budget.
Let’s face it, you have enough on your plate. Your team should be concerned with getting your lifesaving therapy to patients. At AES Clean Technology, we guarantee compliance, so let us take the worry of building your next cleanroom off your hands.