Thank you for purchasing Germfree’s Laminar Flow Glovebox Isolator, the LFGI. With this purchase you have started down the road to making your pharmacy a safer environment for both your personnel and your patients. Before you begin it is important to fully understand the operation of the LFGI and its features.
In this video we will walk you through the entire process, from installation to everyday usage. In the future you can use the menu options to review specific sections of this video for reference during training. Now let’s begin.
It is important that users of the LFGI have a basic knowledge of how the unit works. There are a few basic principles that will help users gain a better understanding of the unit, and contribute to its safe and effective usage for years to come.
Your Laminar Flow Glovebox Isolator is so named because it utilizes Laminar, or Unidirectional flow. What this means is that all air that enters the work area is passed through a HEPA filter before it enters the work area. This air is then drawn through the work area in a single pass, knocking and removing particulates in the air as it goes. Unidirectional air flow provides the work area with the highest possible level of protection because it does not allow particulates to build up, a state that may lead to cross contamination.
Another important concept to understand is pressurization. Your LFGI has been configured at the factory to run under either positive or negative pressure. The pressurization of the LFGI simply refers to the difference in pressure between the work area and the surrounding room.
When the pressure of the work area is greater than that of the surrounding room the unit is said to be under positive pressure. You will notice that the glove sleeves are being pushed out of the unit. What means is that if there is a breach of containment, such as a tear in the glove were to occur, the air in the work area will be pushed out of the unit, providing protection for whatever product was being manipulated. You can see here that even with the sleeve completely removed, the room air is unable to enter the work area. Positive pressure is ideal when working with non-hazardous compounds and when product protection is of the highest importance.
Conversely, when the room pressure is greater than that of the work area, the LFGI is said to be under negative pressure. You will notice that the glove sleeves are being sucked into the work area. In this instance, if containment were lost because of a rip or tear, room air would be sucked into the work area at a rate that would prohibit any air from exiting the unit. Negative pressure is ideal when working with hazardous drugs and in all situations where personnel protection has been deemed to be of paramount importance.
For more complete explanations of Laminar Flow and positive and negative pressure, please consult the LFGI user’s manual. Now let’s get familiar with the product.
The HEPA purge airlock or antechamber allows materials to be easily brought into or taken out of the unit without transferring the room air to the work area or vice versa. Two HEPA filters inside the airlock change out the air during a purge cycle. The purge cycle can be activated by pressing the purge button located on the control panel. Also on the control panel you will find controls to turn the unit on and off, and to control the lights. The control panel also contains a mini helix gauge and a digital pressure gauge. For a full explanation of the LFGI’s gauges and their purpose, consult your owner’s manual.
The LFGI features anthropometrically correct glove ports. These glove ports, originally developed by NASA, have been designed to allow for the greatest possible range of motion for users of all body types.
Opening the airlock from the inside of the unit, you will find a sliding tray designed to facilitate easy transfer of materials into and out of the LFGI.
The unit also contains sliding trays in the work area. These trays make movement within the isolator easier and more efficient. Additionally, these trays can be moved or removed during cleaning to allow you full access to the work area. Trash and sharps tubes, located on the side of the unit, allow the user to easily pass waste out of the LFGI without disrupting workflow.
Your Laminar Flow Glovebox Isolator comes with a height adjustable stand which allows users of different heights to work easily within the unit. A motorized stand is available as an option.
Once you have installed your LFGI and have had it certified you are almost ready to begin use. Please consult your LFGI’s operator manual for detailed information on installation and certification.
To begin, make sure your LFGI is plugged into a functioning outlet. Now it is the time to install the glove sleeves. Regardless of the sleeve type you are using, the sleeve should wrap easily around the outside of the glove ports. Once the sleeve is in place, secure it by using the O-ring clamp.
If you are using a two part glove sleeve, you can attach any commercially available glove. To do this, first pull the sleeve out of the box so that the sleeve is inside out. place the glove over sleeve, or GOS, over the sleeve, and roll the sleeve so it just covers the GOS.
Now, take the O-ring clamp and place it over the sleeve, making sure that it settles into the GOS groove furthest from you.
Often, stretching the glove with both hands will help loosen it and make the job easier. Additionally, this will allow you to check for any defects in the glove. Take the glove and place it inside the sleeve, making sure the thumb is pointed upwards. Now, take the glove and roll the cuff over the sleeve and GOS. Take the second O-ring and place it over the the glove securing it into the GOS groove closest to you.
After the sleeves and gloves have been installed they should be visually inspected for any cuts or tears. When the unit is under pressure the unit’s low-flow alarm will sound if containment has been compromised. You can now push the entire sleeve and glove back into the box.
This procedure can be followed for all glove changes during standard maintenance, however there are procedures for changing a glove during an operation and we will deal with that later in the video.
Next, open the viewing panel. Inspect under the work tray to ensure that there is nothing below the sliding trays, and remove any fallen objects that you find. You will then clean the airlock by opening the interior airlock door and sliding the tray into the work area. Now, open the outer airlock door and quickly spray the floor of the airlock with disinfectant cleaner and wipe down.
Spray a clean wipe with disinfectant cleaner and wipe the top HEPA filter protector from front to back, left to right with overlapping strokes. Now, repeat this procedure on the back HEPA filter.
Repeat this procedure on the inside of the airlock doors and on all sides.
Slide the airlock tray back into the airlock and close the interior door.
Finally, spray the cleaner on the tray and wipe it down in the same manner.
Close the airlock and make sure both doors are latched.
At this point, it is time to clean the interior of the unit. To perform this task, you will need a water-based, hight pH disinfectant cleaner as well as 70% alcohol solution. Because this is the initial cleaning, we will open the front window. If your LFGI is operated under negative pressure you should never open this front window until a thorough cleaning has been performed with the window closed. In this event, all of the procedures that I will describe can be followed, but must take place through the gloves. Germfree can provide you with an isolator cleaning tool to assist you. For more information, please consult your LFGI’s operator’s manual.
To begin, spray disinfectant cleaner on a lint free cleaning wipe. Wipe the filter diffuser on the top of the work area, wiping from side to side, overlapping strokes. Work outward from back to front.
Spray the back wall of the work area. Wipe the wall beginning at the top and wipe top to bottom using overlapping strokes working downwards toward the work surface, and wipe the rear air return grille. Work sideways from left to right.
Repeat the same procedure for the sidewalls.
Slide the left tray over the right tray. Spray the interior bottom surface of the isolator. Clean by wiping from the back to the front using overlapping strokes. Be sure to clean the side and back under the sliding work tray air return grille. Do not spray cleaners directly at the exhaust HEPA filter. Always spray the cleaners onto the cleaning wipe and then clean the protector surface.
Slide both work trays to the left, and repeat the procedure on the right side. Sliding work trays are removable if preferred.
Spray the sliding work tray and wipe using a side to side motion, overlapping strokes, working from back to front, and clean all inside and outside edges.
Remove glove sleeves and spray the inside of the front access window.
Using overlapping strokes, clean from top to bottom. Remember this must be done through the gloves in a negative pressure unit.
Spray a clean wipe with disinfectant cleaner and use it to clean the glove ports.
Spray a clean wipe with disinfectant cleaner and use it to clean the IV hanging bar and hooks.
Spray a clean wipe with disinfectant cleaner and use it to clean the front air return grille.
Spray and wipe the gloves and sleeves.
After cleaning, replace the gloves and glove sleeves.
Spray a clean wipe with 70% IPA and wipe the supply HEPA diffuser in the top of the work area. The supply HEPA diffuser should never be sprayed directly to avoid damage to the filter.
Spray 70% IPA directly on all surfaces of the rest of the work area. Close the front access window, clamp, and allow to dry for 10 minutes. After the the 10 minutes has elapsed, ensure that the stoppers for the trash and sharps are seated in place. If the viewing panel is open, close it. If you want to you can lock the wind at this time.
Now you are going to clean the outside of the unit. The outside can be cleaned at any time while the unit is closed. This procedure does not require that you wear additional personnel protection equipment beyond what you would normally wear when working inside the LFGI. The stainless steel should be cleaned with a 70% alcohol solution, or one that is specifically designed for the cleaning of stainless steel. the acrylic front and side panels should be cleaned with a soft cloth and mild detergent or a solution that’s specifically designed for the cleaning of acrylic. It is important to never use abrasive cleaners or organic solvents on the acrylic. Also, the acrylic should never be cleaned with a solution stronger than 50% ethyl or 70% isopropyl alcohol. Do not use glass cleaner that contains ammonia.
Work from top to bottom. Do not remove or spray the pre filter at the top of the unit.
When cleaning the airlock HEPA filter housings, do not spray directly onto the airlock, rather spray the solution into a cloth and then wipe the outside surface. Raise the adjustable stand at least three inches and wipe down the caster supports.
Never spray any type of cleaner directly at the control panel located above the airlock. Always spray onto a clean wipe and then wipe the surface switches and knobs. Now, make sure the pre filter is seated properly in its frame at the top of the unit. You should not see it above the steel frame. Turn on the work area light, and watch for its operation.
Turn on the main blower switch. The low pressure alarm will sound until adequate pressure is achieved. If the unit is under positive pressure, the gloves will push out of the work area, under negative pressure they will pull into the work area. Push the airlock purge button and make sure that the accompanying red light turns on.
Now, you are ready to work inside the LFGI. For safe and efficient use of the Laminar Flow Glovebox Isolator, you should take into account the equipment and materials necessary for the preposed operation and list the procedural details for each operation. The best way to accomplish this is through the use of a checklist or protocol that includes all equipment, apparatus, tools, products and supplies necessary for each specific procedure. the list should include the order of events in enough detail to successfully carry out the proposed operation. This list needs to be exhaustive including such items as initial cleaning equipment, spill control equipment and even extra gloves in case a change is required in the middle of an operation. It is recommended to perform several trial runs in the Laminar Flow Glovebox Isolator before initiating preparation.
If you are using teach and waste containers, make sure they are attached properly. The trash bag should be secured to the tube by the clamp. If you are using the optional trash container, the bag should fit down into the container.
The sharps container can either be brought into the work area or it can be placed on the side of the unit. In this case the sharps collector shelf should be adjusted so that the sharps tube fits down into the container. This setup is recommended for positive pressure use only.
Now, adjust the stand to a comfortable working height. Wipe down the materials that you will be bringing into the LFGI and place these materials inside the airlock. Push the airlock button, the red light will turn on. Do not open the airlock door until the red light is turned off. The factory has set the purge time at one minute.
Working through the gloves, open the airlock door and slide the work tray out. Remove the items from the tray and slide the tray back into the airlock. Close and lock the airlock door. Now you are ready to begin preparation.
Remember, any waste created can be disposed of through the waste and sharps tubes, however when you are not using the tubes the rubber stoppers should remain in place to assure containment.
During the course of your normal work inside the LFGI, it is possible that you may rip or tar a glove or sleeve. In this event you can easily change out that glove or sleeve without breaking containment. To change a sleeve or glove while maintaining containment, first pull the glove and sleeve outside of the work area so that they are inside out and remove the glove O-ring. roll the existing glove’s cuff down to the first groove of the GOS, the one that is closest to your body.
Now pick a new glove and stuff it inside the existing glove, leaving the cuff out and making sure that the thumb is pointed upwards. Stretch the new glove’s cuff up and over the old one up to the middle groove of the GOS. Secure the new glove with the O-ring at the middle groove of the GOS. Push the glove and sleeve back into the work area. Reach into the work area through another glove and grab the new glove assembly. With two fingers, carefully work the old glove up off the GOS from inside the work area. Dispose of the old glove through the waste tubes, and push a hand into the new glove.
If you were to tear a sleeve during operation. this can also be replaced without breaking containment. First remove the O-rind and move the sleeve to the outermost glove port for you. Push the new sleeve inside of the old one and pull the new sleeve over the glove port down to the innermost groove. Replace the sleeve O-ring to secure the new sleeve. Reach inside the work area with another glove and pull the sleeve off and into the work area. Dispose of the old sleeve through the airlock or trash tubes.
That’s it! You’re up and running in your new LFGI. Now each time you use the unit you must follow the procedures in the following order.
First, inspect the gloves and sleeves to make sure that they are free of any rips or tears.
Clean the inside of the airlock.
Make sure that both airlock doors are latched.
Place your sharps container either on the side of the unit, or inside.
Attach the waste container.
Clean in inside of the work area. Remember, you should not open the view window if you are under negative pressure.
Make sure the stoppers for the trash and sharps tubes are in place. Turn on the work area light. Turn on the main blower switch and allow the unit to pressurize.
Push the airlock purge button and make sure the red light activates. Allow 10 minutes to pass in order to make sure that the work area is filtered numerous times and reaches an ISO class 5 condition.
Adjust the stand to a comfortable height.
Wipe down and place compounding elements in the airlock.
Press the airlock purge button and wait for the red light to turn off. The purge has been factory set at one minute. Once the light is off, open the interior airlock door and remove the compounding elements. Close the airlock door.
Dispose of waste and sharps through the trash tubes, remembering to always replace the rubber stoppers. Remove the completed preparation through the airlock.
Please use this training video as a resource to stay informed on the safe use of the LFGI. More detailed information can be found in your LFGI operator’s manual. Remember the Laminar Flow Glovebox Isolator is a tool to aid the operator in maintaining a clean environment for the compounding of preparations. It is not a substitute for proper aseptic technique. We at Germfree believe that the proper use of our equipment will create a safer environment for patients and pharmacists for years to come.