Take a 7-minute Guided Tour of Azzur Cleanrooms On Demand™ Raleigh

Watch this 7-minute video for a guided tour of our Azzur Cleanrooms on Demand™ facility in Morrisville, North Carolina to learn how we help companies with their GMP production needs, paving the way for a fast path to monetization. Our leased cleanroom spaces drastically reduce your capital expenses while saving you time as you lean on our facilities and expertise. 

We offer the benefits of in-house production development and manufacturing without the burden of constructing, managing, maintaining, and staffing a full GMP facility. Alongside a cleanroom, clients receive standard cGMP services, such as materials management, facility management, personnel support, equipment management, quality management, process gases, and more.

Below is a written transcript of the video for your convenience. If you're seeking more information and additional resources to assist in your decision-making process for your cleanroom facility requirements, we invite you to explore our Azzur Cleanrooms on Demand™ page. Here, you can access comprehensive insights on cleanrooms and even take a 3D virtual tour of our various facilities across the United States.

Hello and welcome to the Azzur Cleanrooms on Demand™ site, located in Morrisville, North Carolina, close to the Research Triangle Park area. 

This business is really designed to accelerate critical therapies that clients can leverage our services, which include GMP manufacturing infrastructure, which is the cleanroom space itself, but also a plethora of other GMP services such as quality management, materials management, asset management, and the list goes on. 

So let's go in and check out our 75,000 square foot facility with 24 cleanrooms designed to accelerate critical therapies. 

2017 We built a few cleanrooms of our own so that the next time a client needed quick space for GMP manufacturing, we could provide that as a service. 

Now, the model is really to enable clients to keep their science while we take care of the compliance. 

First, we're going to take a look at what we call the client bullpen area. 

So each client that has a cleanroom also gets an office that seats about 4 to 6 people. 

In addition, they have access to all the non-GMP services such as office supplies, printing supplies, access to Wi-Fi. 

Another feature of these bullpens is that you can remotely monitor your process without actually having to gown in because there's connectivity between each bullpen and the respective cleanroom.

Before entering the gowning areas there are bathrooms here. 

Everybody has to wash up, but before entering, everybody needs to be trained on the facility procedures at which point they obtain a badge that'll give them access to this GMP core. 

And here we have the supplies required for gowning up before you enter the GMP core. 

The gowning typically includes scrubs as well as a hair net and a beard cover if required. Gloves and safety glasses. 

And now that we have our primary gowning on, we are ready to go towards the clean corridor, which will give us access to the cleanrooms. 

Now we are in the clean corridor, which provides access to the cleanrooms. 

Again, each clean room is access controlled via badge, access. 

Out of the 24 cleanrooms 16 of them are amenable to traditional biopharmaceutical manufacturing, which includes air cascades from the core out to less clean areas. 

And the rest of the cleanrooms are designed for higher control processes such as viruses or high potency compounds, where the airflow is the opposite direction and it's a containment suite to protect the rest of the environment. 

And now we have entered the anteroom space.

Here we provide some standard storage options of 2 to 8 degrees centigrade, as well as -20 degrees centigrade storage. 

Each of these monitoring systems have alarms associated with it so that any events that happen during off hours are automatically notified to make sure that prompt action is taken. 

And here we have a material pass-through. This is for pass-through if any raw materials or other materials that need to go into the cleanroom core.

 I'm going to don these secondary gowning supplies in a dedicated airlock that's behind me, which is called the personnel airlock. 

Now that we have entered the cleanroom core, this is an ISO 7 space that is fully controlled, both in terms of the pressure cascades, but also the temperature and humidity at all points of time. 

The air is controlled through HEPA filters. 

The cleanrooms are also equipped with various gases for process use. 

The location of these drops can be relocated as well to provide flexibility in terms of process operations.

The stainless steel furniture that you see in these cleanrooms are also provided by us as a standard offering. 

We are able to provide additional furniture as well, depending on each client's request. 

These are ISO 5 qualified biosafety cabinets that allow for any open processing to happen in the cleanroom. 

These are modular panel-based cleanrooms that are amendable to high level of flexibility in terms of design. 

You can connect adjacent cleanrooms with each other to create a much larger space. 

You can also reconfigure the cleanroom itself by providing panels in strategic areas to provide additional controls in terms of air. 

The entire facility is backed up via emergency power that's onsite. 

In order to maintain compliance to the various regulations, whether it be the US or the European regulations, the facility is designed to ensure unidirectional flow of personnel, material, and waste. 

So now I have taken off my primary gowning materials and I've entered the exit corridor. 

This exit corridor provides a way for personnel to get back into the locker rooms for a complete de-gowning, and then there's a separate exit for the waste that comes out of each cleanroom.

That waste gets accumulated in a satellite storage area prior to collection at a certain cadence. 

Now, some of the additional features of the cleanrooms include interlocking of the doors that lead into each cleanroom or exit from each cleanroom. 

This is to ensure that there is minimal risk of cross-contamination because of air mixing from a less clean to a more clean area. 

Now, in addition to these security features, we also have safety features. 

So in case of a spill that a spill gets in each cleanroom to make sure that the personnel have ready access to tools to clean up the spill. 

In addition, there are safety showers in the exit corridor in case of an event of a spill where personnel need to wash themselves. 

And now we're headed back to the locker room where we'll complete the de-gowning process. 

And now we have entered the GMP warehouse where a majority of the material storage happens. 

So the temperature ranges that we can support in this warehouse include ambient 2 to 8, -20, -80, and cryogenic or liquid nitrogen storage. 

And in this area we will see standalone refrigerators and freezers. 

We are able to store materials in conditions such as 2 to 8 degrees, -20, and -80 in these standalone units. 

In addition to these standalone units, we also have walk-in units for -20 and 2 degrees centigrade storage. 

And over here we have the Azzur seating area for our internal staff. 

This includes the quality personnel, the client operational personnel, and the facility personnel that take care of the various aspects of GMP compliance, but also client satisfaction while they're in our facilities. 

We provide other services and amenities such as a gym onsite, a large break room, collaboration areas such as conference rooms and the lobby itself.