QA Processes for Your Compounding Equipment


December 2005 - Vol. 2 No. 7

A Q&A with Patricia C. Kienle,
RPh Operations Director for the Pharmacy Management business of Cardinal Health

Q. What specific QA/QC policies should pharmacy put in place for the compounding of TPN?
A.
TPN compounding can be a very simple and low-risk process, involving simply adding a couple of components to a premixed product. On the other end of the spectrum, if you are making TPN with a nonsterile product, you are engaging in a high-risk process. Between these two processes, you have the most common practice: mixing dextrose, amino acids, and perhaps water with or without an automated compounding device. This is a medium-risk process, and probably accounts for about 90 percent of all TPN compounding.

In terms of QA/QC process for TPN compounding, regardless of your risk level, you need to first make sure that your process is solid and that your staff approaches the activity very systematically. This is not the time for your staff to get creative; everyone should make the same compounds in the same way every time. If you are using a compounder, be very clear with your staff that they need to perform the checks and balances to be sure that the right port is attached to the right solution, and via either volume or gravity, you should have a way of checking the final product. In addition, read the equipment literature, as most manufacturers provide a list of QA processes to follow when using the devices.

Q. Do you have any tips for ensuring the safe operation of a compounder?
A.
The specific approach differs depending on the compounder. Nonetheless, in every case, you need to make sure there is a double check on any solution hooked up to any port. I would suggest you bring in the manufacturer to provide an in-service for your staff. You can also request printed or video in-services. It is important to note that changes and enhancements may have been made to the system since the original installation, and your people may have loaded software upgrades to the device without even realizing it. Therefore, it is a good idea to ask the vendor for the most up-todate information possible.

Q. Are most pharmacies performing volumetric and gravimetric tests on their compounders?
A
. These are new terms to most of us. You might read <797> and say, “I haven’t heard these words since pharmacy school.” I am sure very few people have done the initial gravimetric and volumetric tests recommended in USP <797>. People have had compounders for years and have probably never done these tests. So the first step is to read <797> and then perform those tests. Alternatively, you could perform a comparable test recommended by the product manufacturer. This approach may be easier and the test should be well described in the product literature.

Q. What routine maintenance should be performed on compounders?
A.
Make sure that the biomedical equipment people at your facility know about the use of your compounders, because at many hospitals, they do not. After all, if they check every other piece of medical equipment in your facility, they certainly need to be checking the compounders as well. Consequently, this adds a double check to your system, because someone outside of pharmacy will now evaluate the equipment routinely as well.

Q. Do pharmacies tend to inadvertently leave any devices out of the QA process?
A.
In addition to compounders, a lot of pharmacies also use repeater pumps to fill syringes or piggybacks. Repeater pumps also need to be part of your QA process, and biomedical engineering needs to know about them, too. Fortunately, it is easy to do quality control and volumetric tests with these devices. If the manufacturer claims the repeater pump will deliver 50 mL for the next 500 repetitions, you simply need to check the filled syringe or piggyback to make sure the device has done so. Part of each run should include measurement and documentation of at least one product.

Q. What are the QA concerns for laminar airflow workbenches?
A
. Hoods need to pass certification every six months. I like to see “naked” hoods. In other words, I do not like to see unnecessary items in hoods. There is no reason to have extraneous labels, needles, and so on in the hood. Outside of the core equipment needed in the hood when compounding, most of the time nothing should be in it. Messy hoods bother me from a QA standpoint, because the mess obviously interrupts the airflow. As such, those extraneous items compromise the integrity of the hood’s environment, and they just should not be in there.

An employee of Cardinal Health Pharmacy Management since 1999, Patricia Kienle assumed her current position in July 2004. The recipient of an MPA in health service administration from Marywood College in Scranton, Pennsylvania, and a BSc in pharmacy from Philadelphia College of Pharmacy and Science, Kienle has more than 30 years’ hospital pharmacy experience.

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