From Pahwiki

Flolan mixing is a "personal" process typically adapted to one's personal inclinations and capabilities. What's described here is one approach to Flolan reconstitution. The applicability of this approach is entirely dependent upon your personal circumstances.

My philosophy on Flolan reconstitution is to obtain the highest level of sterility through careful processes and consistency of the process. The process has been refined over the years to minimize the number and length of time critical sterile surfaces are exposed.

Note: There is another page, essentially a supplement to this one discussing Needleless based preparation techniques. This page talks in comprehensive detail of the full process, from personal and area preparation down to the last step of getting the bubbles out of the cassette before using (or refrigerating) it. The other page, on a Needleless process, talks about how to do the same thing --- mix and prepare your Flolan --- but without making use of hypodermic needles, and it focuses just on the distinctive steps where you would otherwise be using needles. So all that is said below about early prep and concluding stages is still relevant.

Contents 1 Flolan Mixing Area setup 2 Step 1 - Hand washing 3 Step 2 - Surface Preparation 4 Step 3 - Supply Placement 5 Step 4 - Diluent and Flolan bottle preparation 6 Step 5 - Flolan Mixing 7 Step 6 - Diluent Syringes 8 Step 7 - Injecting Flolan and diluent into cartridges 9 Step 8 - Cartridge air removal 10 Step 9 - Cappping and Storage 11 Final Wrapup

[edit] Flolan Mixing Area setup

Two surfaces are used for Flolan preparation. When away from home or when convenience is a factor, Tidi Sterile field towels are used. These disposable 18" x 26" field towels work well on any hard level surface. A thin plastic layer makes them waterproof, which helps to protect table finishes when excess diluent is removed from the syringes.

At home, a solid surface 14" x 14" preparation surface is used. The solid surface should be non-porus and easy to clean. In this example, we used a purchased kitchen cutting board made of Corian. It is entirely dedicated to Flolan preparation, and is not used as a cutting board.

[edit] Step 1 - Hand washing

Wash your hands between three and five minutes using an anti-bacterial soap. Fingernail cleaners also help to ensure that bacteria underneath the fingernails is removed. People typically forget to wash their thumbs, so do not forget. Also, I remove all finger and wrist jewelry when washing my hands and performing the subsequent Flolan reconstitution.

When turning off the water faucet, always use the back of your hand, and not your fingers, to reduce the likelihood of contamination.

[edit] Step 2 - Surface Preparation

Prepare the surface upon which you reconstitute the Flolan. If a sterile field towel, remove it from its packaging, unfold and place it on a solid level surface. Avoid touching the top surface of the field towel.

If a solid surface, clean the solid surface by using two alcohol patches placed in the center of the solid surface. Work the patches to the outer edges of the surface by following a spiral pattern from the center. On the periphery of the solid surface, be sure to sterilize the edges. Do not re-wipe the surface with the alcohol swipe. Do not touch the surface after it has been cleaned. Discard the alcohol swipes when done.

[edit] Step 3 - Supply Placement

Flolan supplies are kept in a convenient storage location near the area where I reconstitute the Flolan. In order to minimize contamination, I routinely pull the supplies in the same order and place the items on the preparation surface in the same location. If at any time during this process my hands touch anything other than the medicine, I rewash them.

Specific steps to medicine placement:

1. Pull diluent boxes, remove bottles and place in upper right hand corner of preparation area
2. Pull Flolan box, remove bottle and place in upper right hand corner of preparation area below the diluent.
3. Remove 5 ml syringe from its packaging and place on right hand side of preparation table
4. Remove 50 ml syringe from its packaging. Hold in left hand while opening needle package. Connect syringe with needle without touching either in the vicinity of the needle. Place to the left of the 5 ml syringe.
5. Remove second 50 ml syringe from its packaging. Attach needle as described previously. Place to the left of other 50 ml syringe
6. Place 4 packs of detached alcohol pads on the preparation area.
7. Place opened cartridge and end cap on upper left hand corner of preparation surface.

[edit] Step 4 - Diluent and Flolan bottle preparation

1. Remove the protective caps from the diluent and Flolan bottles.
2. Place the bottles in their original positions

[edit] Step 5 - Flolan Mixing

1. Pull the plunger back on the 5 ml syringe, drawing air in until the plunger end reaches 10 ml.
2. Remove the protective cover on the syringe
   

   

   Withdrawing the diluent
3. Insert the syringe into a diluent with the syringe hole facing up. This helps to avoid pieces of rubber in the diluent.
4. Press the syringe plunger until all of the air is expelled from the syringe. Draw the plunger back a couple of times until the majority of the air bubbles are removed from the syringe.
5. Inverting the diluent bottle and syringe, draw 5.4 ml of diluent into the syringe. When 5.4 ml is reached, turn the diluent bottle and syringe right side up and withdraw the needle.
6. Tap the 5 ml syringe on the side of the preparation area while holding it at a 45 degree angle. Be certain to only tap the syringe on a surface that was previously disinfected.
7. Holding the 5 ml syringe upright, draw 1 to 2 ml of air into the syringe to capture the bubbles dislodged from the previous step. Rotate the syringe and angle it to capture bubbles attached to the side of the syringe.
8. Press the plunger until 5 ml of diluent remains in the syringe.
   

   

   Injecting diluent into the Flolan vial
9. Insert the 5 ml syringe needle into the Flolan bottle. Holding the bottle and syringe horizontally, inject the diluent to the top surface of the Flolan bottle to avoid the creation of bubbles.
10. Once the dilluent is injected into the Flolan, maintain pressure on the plunger and rotate the Flolan bottle 3-4 times to ensure that the powdered Flolan is completely dissolved. Be certain to dissolve the pesky Flolan that reside around the cap of the bottle.
11. Invert the diluent bottle and syringe, withdraw the needle from the bottle slightly to ensure the tip of the needle is below the liquid line, and release the plunger. Slowly withdraw the needle tip as the liquid enters the syringe until all of the liquid is removed from the bottle. You must get the entire amount of liquid as your final reconstituted Flolan concentration is highly dependent upon the amount of liquid removed on this step. Even .1 to .2 ml of leftover fluid in the Flolan bottle with significantly alter the final concentrations.
12. Withdraw the needle from the Flolan vial and cap it.

[edit] Step 6 - Diluent Syringes

1. Remove the needle cap from a 50 ml syringe
2. Draw the plunger back to 50 ml, filling the syringe with air.
3. Insert the needle into the diluent bottle previous used to reconstitute the Flolan. Be sure to face the needle hole up and away from the rubber stopper.
4. Invert the diluent and the syringe, press the syringe plunger in and allow the internal pressure in the diluent vial to force the diluent into the syringe. Depending upon your hand strength, you may need to do this several times.
5. As the liquid level in the vial decreases, carefully and slowly withdraw the needle until all of the diluent in the vial is transferred to the syringe.
6. Remove the needle from the vial and discard the vial
7. Cap the needle.
8. With the syringe still needle side up, pull approximately 5 ml of air into the syringe. Angle the syringe and rotate in order to capture as many bubbles as possible.
9. Press the plunger until all of the air in the end of the syringe is removed. You should have roughly 47 ml of diluent remaining in the syringe.
10. Sharply tap the side of the syringe on the edgle of your preparation surface or on the edge of a sterilized surface, dislodging the bubbles towards the bottom of the syringe
11. Pull approximately 5 ml of air into the syringe, rotate to capture the bubbles, and press the plunger until all of the air in the end of the syringe is removed.
12. Continue to press the plunger until the total sum of the 5 ml syringe Flolan volume and the diluent volume in the syringe is 50 ml.

[edit] Step 7 - Injecting Flolan and diluent into cartridges

1. Stand the cartridge upright with the tubing facing the cartridges
2. Pick up the 5 ml syringe in one hand and the tubing end in the other. Unscrew the end cap and the needle. Connect the syringe to the tubing.
3. Inject the reconstituted Flolan into the cartridge by depressing the plunger all of the way down.
4. Retract the plunger slightly and press all the way down a second time to ensure that all of the Flolan is injected into the cartridge and that some air remains in the tubing.
5. Unscrew the 5 ml cartridge and disgard.
6. Pick up a 50 ml syringe, unscrew the needle and connect the syringe to the tubing.
7. Inject the diluent into the cartridge by depressing the plunger all of the way down. Withdraw the plunger slightly and depress all the way down to ensure that a small amount of air remains in the tubing.
   

   

   Injecting Diluent into the cartridge

[edit] Step 8 - Cartridge air removal

1. While holding the cartridge at a slight angle so that the air collects in the upper corner of the cartridge closest to the tubing entry point, withdraw the syringe until all of the air in the cartridge is removed.
2. While still holding the syringe plunger in the same position, sharply hit the bottom of the cartridge against the preparation surface. Any bubbles trapped in the bottom of the cartridge should be dislodged to the side or top.
3. Place the cartridge upright and standing on the preparation surface and depress the syringe plunger to reintroduce air into the cartridge.
4. Carefully shift the air in the cartridge to capture all bubbles on the sides of the cartridge. Be certain not to reintroduce bubbles in the folds of the plastic sleeve.
5. Return to first step; cycle through these steps as often as needed until all major bubbles are gone. (It is OK to leave a few very small bubbles; the filter on the line will eliminate them.)

[edit] Step 9 - Cappping and Storage

1. Remove all air from the cartridge and its tubing by withdrawing the syringe plunger. Be certain to not draw too much medicine into the syringe as it will be discarded.
2. Carefully remove the end cap from its protective packaging and place on the connector.

[edit] Final Wrapup