Department of Pharmacy Policies & Procedures

Number: 5:12.5    

Effective Date: OCTOBER, 1992    

Revisions: 5/99; 12/04; 4/09

Reviewed: 9/09

Approval: OCTOBER, 1992

Subject: AUTOMATED COMPOUNDING SYSTEM

A.    POLICY

The Automated Compounding System is an automated pumping device that compounds multi-ingredient sterile formulas by withdrawing requested amounts of source ingredients from their containers in a user-specified sequence and pumps them into a final container.  It is primarily used to prepare TPN solutions, but it is also used for other specialty IV products.

B.    TRAINING ON THE USE OF THE SYSTEM

1.    All pharmacists will be taught in an experiential one-on-one situation to use the Automated Compounding System. 

    2.    A written assessment on the operation of the compounder will be completed after viewing an orientation video.  A practical assessment on the use of the system will be completed by the pharmacist and signed by the training pharmacist when the knowledge and skills sets are completed.  The written and practical assessments will be filed in the personnel file.

    3.    The Exacta-Mix 2400 Technical Manual will be kept in the computer order entry area for reference when needed.  References below are to revision “H” of the Technical Manual, copyright 2009.

C.    DAILY SYSTEM OPERATION AND CARE

    1.    Each day the compounder will be cleaned, calibrated, primed and the tube set will be exchanged.  The laminar air flow hood housing the compounder will also be cleaned each day.  The compounder should also be shut down or rebooted every day.  Shutting down or rebooting is necessary to allow the software to perform routine database maintenance.  Refer to Technical manual pp. 18-20, 46 for proper procedures on shutting down, powering up, and rebooting the compounder.

        a.    Remove the old tube set and source containers from the compounder and discard (refer to Technical Manual, p. 40 for proper procedure). 

        b.    The compounder should be cleaned at the time that the tube set is exchanged.  Clean the machine with 4x4 gauze pads wet with soap and water.  Rinse with gauze wet with water and then wipe with alcohol.  Refer to Technical Manual, p. 129 for proper procedure.  The hood housing the compounder should also be cleaned with alcohol at this time.

        c.    Attach the new tube set to the compounder as described in the Technical Manual, pp. 26-28.  Install the valve body and make sure that it is securely in place by pulling up on the valve body.  Feed the valve tube over the occlusion detector as shown on p. 27 of the Technical Manual.

        d.    Remove the inlet from its package and attach it to the appropriate valve port.  Next, spike the corresponding source container and hang on the appropriate hanger.  Finally, label the inlet with the appropriate inlet bar code label.  Refer to Technical Manual pp. 29-32 for proper procedures, including the correct spiking technique.  Repeat for each source container.  All source containers hung at any time during the 24 hour period will be initialed by the person hanging the fluid.

         e.   Inspect the compounder to ensure correct valve set installation, proper spiking of all source containers, and that no tubing is kinked.

        f.    Calibrate the load cell as described in Technical Manual pp. 22-23.

g.   Prime and verify the compounder as described in Technical Manual pp. 32.

h.   Calibrate the compounder as described in Technical Manual pp. 37-39.

i.    The person performing the cleaning and calibration of the compounder will document all parts of the procedure on the Automated Compounding System quality assurance log.  Documentation of the person setting up the compounder and who verified the setup will be documented on the Authorization Report.