I’d like to welcome you today to Germfree Laboratories’ Mobile USP 797 compliant cleanroom. We’d like to just take a few minutes to walk you through the facility so that you can see many of the same features that you’re used to in your facility’s cleanroom today, however just in a compact environment. If you can imagine fitting everything you have inside your hospital inside a 53 foot trailer, that’s what we’ve done and we want to show you how you can maintain operability while renovating your existing facility.
Once again a fully compliant USP 797 facility which allows you to move your operation from the hospital into this facility, continue uninterrupted while you bring your facility up to the current standards.
Now lets go over some of the things we’ve included in this operation that we have, this mobile pharmacy cleanroom. We’re standing now in the entry room or the office are, so as you come through the entry door, which is just over here behind the camera where he’s standing now. You’ll come into this area where the pharmacists will be stationed. We have two different desks, or work areas set up, and similar to what we have in all of the cleanroom applications, we have stainless steel furniture that’s set up. It’s very cleanable. It’s very smooth, so that when you have personal protective equipment on and you’re wiping this down, it allows for a good cleanable surface to work with. Let’s talk about the walls of the facility. The walls are made up a material that’s referred to as Arcoplast, which is a very cleanable compound. It’s not permeable to any type of object that would get through it and stick so in order to keep your contamination levels down, or your sterility, this is a premium product. The walls are then sealed up into the ceiling grid as well as into the other walls and doors. The floor material that we have is a Medintech laboratory medical grade flooring, similar to what you have seen in your hospital set up. Its heat welded seams and coved up the walls, again you have a non permeable floor to work with.
We have two separate rooms in this mobile pharmacy. We have a hazardous drug buffer room and on the other end we have a non-hazardous drug buffer room. So, the hazardous drug room is running at a negative pressure, in order to do your chemotherapy compounding. Obviously the positive pressure room for all of the normal sterile compounding of your IVs.
In order to pass things in and out of the buffer rooms from the office area, or the entry, we have a pass-box. This pass-box also has a HEPA filtered purge system, so any particle count that could be in the air here in the office will be cleaned out by that HEPA filtered purge before it’s passed into your positive pressure buffer room.
This office area is maintained in ISO 8 conditions at its very worst, but you’ll see in the ceiling we have HEPA filtered ventilation with fan filter units. We also have low wall returns, so this area is bathed with a constant filtered air supply with many air changes per hour going on in here in order to clean the air constantly.
Also, some of the features that we have in the facility for enhanced security and monitoring of what’s going on in the exterior as well as the interior, we have a CCTV, or a camera system, which also is recorded on a DVR, so from the exterior security standpoint you are able to monitor what’s going on 24 hours a day, 7 days a week, and record if anything were to occur, as well as with cameras that are inside the mobile pharmacy.
Now, for communications we have an intercom system. That intercom system allows you to communicate in multiple different ways. You can communicate from the exterior door outside, into the entry area, you can also communicate into the positive pressure buffer room or the hazardous drug buffer room. Additionally, for security purposes, we have an alarm system. The alarm system monitors the entry door, the emergency exit door that’s in the negative pressure room, as well as the door on the mechanical space which is on the back of this particular trailer.
The entry door is controlled in two fashions: one by a standard key deadbolt and the other by a combination lock so that easy access can be gained with the combination lock for your personnel entering the facility during the day. When you want to secure it at night, simply lock the deadbolt with a key tip of a lock to provide more security.
Once again here in the entry room we’ve got our ceiling grid is made up of a cleanroom grade typical ceiling grid, however we have ruggedized it to be substantially stronger than what you may find in the normal cleanroom. For the sake of this being a mobile, so it can handle the rigors of being on the highway to come to your facility and then be set up and still be in place.
The lighting that’s in place is a T5 fluorescent light so we have a nice bright light as you can see in this room to aid your workers in doing their work accurately. In the event that there’s a loss of power, in each individual room there is emergency lighting ballast, so the room will still be well lit to provide any necessary exit that might occur while the loss of power is going on. Additionally with the loss of power, we’ve also backed up the mobile cleanroom with a generator. So the generator is capable to one of the two air conditioners, all of the fan filter units and exhaust blowers, the biosafety cabinets that are used for the chemo compounding, as well as the positive pressure vertical airflow units that are used in the sterol compounding area, and the refrigerators. So all of your operations can continue in a safe fashion. All off your drugs will still be refrigerated, all of your pressures will be maintained, all of the cabinets will still be working. So not only will your technicians be still protected, but as well as the drugs that they are particularly compounding at the time will still be protected. So we’ve pretty well covered everything that we have in the entry room. We can now go on into our change room, or anteroom that we have.
Okay, as we enter into the anteroom, going into the hazardous drug buffer room, we have magna helix on the wall to verify that the proper pressure is maintained as you go into the room. So you can see that we have +.03 inches of positive pressure in the room, so we know that there’s clean air leaking out of there. We’re safe to go into the anteroom, the room.
Now for the purpose of the demonstration, we’ve propped the door open to the anteroom, but obviously it would be self-closing with the door-closer on. So, we come into the anteroom. If it’s necessary to sit down to put on outer covers over the shoes, we have a fold down bench here on the wall. Makes it convenient to get up and out of the way or to use if necessary. Obviously a key component to what’s going on here is we have a hand washing sink. So we have heated water to be able to wash your hands. In addition we have an emergency eyewash station here if there was a need for an eyewash. Soap dispenser, towel dispenser on the wall. Additionally we have small shelving up here to house the PPE that’s necessary for donning before going into the hazardous drug room. As we come in through the next room, obviously this door would be shut, we can again verify on the pressure gauge on the wall that we have the correct negative differential pressure across this door. So we can now verify before we go into the room that our negative pressure there is desired, it’s safe to go into the room, we can go into the negative pressure room.
Okay, so now we are here in the negative pressure room where the hazardous drugs are compounded. You can probably hear more of the airflow that’s going on because we have our biosafety cabinets operating. We have the thimble with the exhaust operating. So everything that’s functioning in here to maintain the room in it’s safe condition is operational at this point. You probably also can tell that the sound level is actually relatively low. So with the amount of airflow that’s here that’s required, it’s still a comfortable working environment. I’ll point out a few things that we have in the back of our mobile pharmacy cleanroom. We have an emergency exit door that’s provided. We always feel that that’s essential in a mobile application like this. If there were an emergency that were blocking the entry door, whether it’s inside or outside, a person can open the door and they can safely get out and not be trapped inside. And then of course, the heart of all of this, we come back to our Class II A2 Biosafety Cabinets which, of course, are Germfree equipment installed. All stainless steel. Stainless steel work deck. This is the premier equipment for doing your hazardous drug compounding. In addition to the other cabinet that we have, we also have a rolling workstation here. So, the necessary equipment can be put on these shelves. We don’t have them in place right now, but they’er in addition to these fixed shelves that are on this cart. We have several places for adjustable shelves. This ends up having a total of five shelves when it’s all said and done.
Over here next to the biosafety cabinet then, we have our cleanroom compliant refrigerator, glass door, wire racks inside. It has alarms for a high temperature situation. Also has a chart recording so that you can always verify that the temperature has been maintained. You can always verify that the drugs have been maintained at the right temperature.
And then again just around the corner we have another shelving unit, just a little smaller than the first. Again it has fixed shelves and additionally will have adjustable shelves on there.
As we were in the entry room, we talked about having an intercom system. So, here is the intercom that interfaces with our hazardous drug room to any of the other rooms. Now when a call is placed from the entry room into here, so if the pharmacist wants to talk to the technician that’s back, they will have to push a button to activate the call. However once it’s activated the technicians that are in this room functioning can communicate hands free. So, when they have their sterile gloves on there’s actually no need for them to touch a button if the call was initiated from outside.
Additionally, we talked about security cameras, both only do we have the monitor in the entry room for the security cameras, but it’s also monitored back here. Above the monitor, we also have the camera that’s monitoring this room. for the safety and security, as well as making sure that technical accuracy is upheld within the room.
As we come back into this area, we come to the opposite of our pass through box. So again, when it’s necessary to pass a tray of sterile drugs out, they can be placed in here. Once the door is shut, it activates the purge. The lights indicating now, I don’t know if you can hear it, but there is a faint sound from the blower running, which is actually circulating air through here, through the HEPA filters, to remove any contaminates from the air as they’re passed through.
Also in this hallway, we have a work surface where any writing can be done to take notes, documentation of what’s happening with the drugs as they’re passed out. Again, like all of the furniture that we have, this is stainless steel, it’s coved, it’s seamless. So again, very cleanable, easy to maintain, and not a place for really any contaminates to permeate the surface.
In this wall, also we have both of our air conditioner thermostats. These are set up to maintain the correct temperature that you need in the cleanroom. With the amount of personal protective equipment required to be worn, always necessary to keep a cool environment so that your technicians are comfortable. This will easily maintain a sixty-eight degree environment. So, they are very comfortable in their working situation.
We’ve now exited the negative buffer room, or the hazardous drug room. We’re back into the entry, and we’re about to go into the positive pressure buffer room. So once again, before we go into the anteroom, we have a pressure gauge here indicating that we have the right positive differential pressure across that, indicating it’s safe for us to go through this door and into the anteroom.
We’re now in the anteroom for the positive pressure buffer room. As we look around, here we see all of the same features that we found in the other anteroom. We have the fold down seats that aid in donning the PPE footwear, the shelving, the sink. Everything is identical in here, with the exception of the fact that we have a small step up in because we’re now going into a slightly higher elevation in this mobile facility, which is actually on a trailer platform. So, as we are now coming into the positive pressure room, again we have a gauge indicating that we have a safe positive pressure, differential pressure, across this door. It’s now safe for us to go through and into the positive pressure buffer room.
We’ve now come into the positive pressure buffer room. There’s a lot of things going on up here with shelving and workstations. The Germfree equipment.
I want to talk about some of the airflow and the air quality conditions in here. The airflow in all of the rooms is coming in from the top through the fan filter units. Coming down across the floor and then exiting through low wall returns. There are return grills all the way across the front wall of this providing for a nice directional airflow that’s happening in this buffer room.
Again, where all of the business is occurring in this buffer room is in the Germfree equipment up here. This is a vertical laminar flow workstation. A new design that Germfree has just implemented, where the blowers are actually underneath and directing airflow from underneath and then bathing the work surface in that HEPA filtered air whine the compounding is occurring.
Again, we have the workstations like you saw before. These have outlets on the backsplash for any equipment that might be set here. The adjustable shelves that can be set at different heights to accommodate different heights of equipment you may have. And now again, we have a shelving unit similar to what we looked at in the negative pressure buffer room. However these do already have installed their adjustable shelves. So you can see, there’s actually a very large amount of storage that’s afforded here. Again, a lot of adjustability, and the shelf heights. And if you can see this here, we’ve actually got a coved lip, so if anything were to be spilled on these smaller shelves it would all be contained right here within that surface.
With the workstation that we have, not only do we have this countertop surface and the adjustable shelves, but we also have a rolling bin cart. So, it’s very easy for the operators to now take this bin cart, set it aside. They can put any tools that they’re working with, they can put their particular bins of supplies and have it as a ready access. It’s also convenient then to simply store that backing out of the way, and not waste any floor space in the room.
And again, in the positive pressure buffer room we have the laboratory and pharmacy approved refrigerator. It has the adjustable shelves inside, which again are a wire rack. Temperature alarm, indicating that you have a high temperature or a low temperature in the refrigerator. As well as the strip chart recorder, again to verify that everything in the contents of the refrigerator have been maintained at the proper temperature.
Also, in this corner, which is very similar to the negative pressure buffer room, we have the pass box, which allows for the passing of the compounded drugs into. Place the tray in the door. Shut the door. The blower starts, allows for the purge, once again, then you can pass out without exchanging any particles between rooms.
Again, you have another work surface that’s here. Stainless steel, coved, seamless, just like all of the other furniture in the facility.
Another important safety feature that we have in this room, and every room of the facility, is a combination smoke detector as well as a carbon monoxide detector. Everyone understands the smoke detector, however, because this is a mobile facility with a generator onboard, it’s really important to have the detection for carbon monoxide. In the very unlikely event that exhaust gasses were to somehow leak into the facility, this would alarm alerting that it was necessary for the technicians to safely evacuate until the conditions corrected.
Up on this front wall of the room, we have the security camera for monitoring what’s going on in this particular room, as well as the monitor, which mimics what’s being displayed in the entry room as well as in the negative pressure buffer room. And then we have the intercom, which allows for communication once again between the entry and the other buffer room, or here and the front entry door. And notice that we have clear windows here, as well as here, and down below. This provides for great visibility between the entry room and the positive pressure buffer room, as well as back in the negative pressure room. Great visibility between the office and these spaces, so it’s very easy for the pharmacist to monitor what the technicians are doing. It’s very easy to see from one room or the other what’s going on, and provides for greater visual cues as well as the voice communications that can happen.
We’re back in the entry office area again and some things to point out. When we’ve passed sterile drugs out of the positive pressure buffer room, we have another work bench area here, and a place to set a tray down, also a place to record data that’s necessary with the transfer of those drugs. And then down underneath, an access door where we have our plumbing connections. So we have a fresh water tank, a gray water tank, as well as fresh water pump in order to provide a supply of water to the two sinks in the anterooms as well as then handle the waste from that and collect that onboard.
Some of the more control type features that we have here in the entry. We have a combination panel here, which monitors out 12 volts. We have two batteries onboard: one that’s operating for our pump and things in the laboratory, and another that’s for the start for the generator. The breakers that also operate courtesy lights, water pump. And then we have a control panel for our generator that’s onboard. As well as a fuel level indication. And then we have a tank monitor indication for our fresh and gray tanks. So, for example, when I push the fresh tank, it provides the read-out in a percentage indicating to me that I have seventy-nine percent full on the fresh water tank.
The panels that we have here are the breaker panels, which provide the AC power distribution throughout the mobile pharmacy cleanroom. This panel is the one that maintains all the essential loads and is backed up by our generator. This panel is the less essential loads such as, some of the miscellaneous outlet power, tank heaters, and things of that nature.
I want to thank you for taking the time to watch this video. It’s really important for Germfree Laboratories to be able to express to our potential customer base what the potential uses are for this facility. You may have the need to renovate your cleanroom in your facility, and it’s necessary to not shut down your compounding, but have the ability to move over and seamlessly transition right into this facility. To provide a short-term rental solution and not interrupt the flow of drugs that you need. So once again, thank you for taking the time to watch this video.