Aseptically Transferring Drug From a Vial

There are two types of parenteral vials that are used in making admixtures: (1) a vial that already has the drug in solution, and (2) a vial that requires a lyophilized powder be dissolved in a diluent to make a solution. In either case, a needle will be used to penetrate the rubber closure on the vial.

To prevent coring use the following technique:

1. Place the vial on the work area surface and position the needle point on the surface of the rubber closure so that the bevel is facing upward and the needle is at about a 45 - 60 degree angle to the closure surface.
2. Put downward pressure on the needle while gradually bringing the needle up to an upright position. Just before penetration is complete, the needle should be at a vertical (90 degree) angle.

If the drug is already in solution, then the aseptic transfer technique is as follows:

1. Draw into the syringe a volume of air equal to the volume of drug solution to be withdrawn.
2. Place the vial on the work area surface and penetrate the vial without coring.
3. Invert the vial. Use one hand to hold the vial and the barrel of the syringe, and the other hand to hold the syringe barrel.
4. Inject the air into the vial and withdraw the drug solution. It may be necessary to use successive small injections and withdrawals to exchange the air in the syringe with the solution in the vial.
5. Fill the syringe to a slight excess of the drug solution. Remove all air bubbles from the syringe by tapping the syringe. Then fill the syringe to the correct volume once air bubbles have been removed.
6. Withdraw the needle from the vial.
7. Transfer the solution in the syringe into a final container, again minimizing coring.

If the drug is a lyophilized powder in a vial, it will need to be reconstituted before it can be withdrawn. First, determine the correct volume of suitable diluent to use. This information will be in the drug product information. Then the following steps can be followed:

1. Perform steps 1 - 6 above to draw the correct volume of diluent into a syringe.
2. Transfer the diluent into the vial containing the lyophilized powder.
3. Once the diluent is added, remove a volume of air into the syringe equal to slightly more than the volume of diluent added. This will create a negative pressure in the vial and decrease the likelihood that aerosol droplets will be sprayed when the needle is withdrawn.
4. Withdraw the needle.
5. Swirl the vial until the drug is dissolved.
6. Using a new needle and syringe, perform steps 1 - 6 again to withdraw the correct volume of reconstitute drug solution into the syringe.
7. Transfer the reconstituted drug solution in the syringe into a final container, again minimizing coring.