This is the second in a series of posts that I’m writing to fully explain the “new” Competency Testing in Aseptic Manipulation assessment in the latest revision to USP <797>. In this article we’re going to talk about media fills. This always seems to be a topic that people scratch their hands and ask, “should I just buy a kit to do this?” My response to this question is typically, “do you compound with kits?”

I think people over complicate and over think this. It’s actually extremely simple. But in order for me to tell you how to do it, you need to answer some questions first. Let’s begin.

1. Think about a compounding process that you or your technicians do that you dread doing because it takes too long, there’s a lot of units that you need to make all at once, requires multiple people. Really, all I asking for is what is your most complex and difficult compounding process. Here’s some examples:

• TPNs
• Non-sterile to sterile (but if this is all you do, think about the longest process where you make a lot of units, maybe you need to use a repeater pump – the compound(s) your techs don’t particularly look forward to doing)
• More than 2 or 3 active ingredients, all in separate containers that need to be mixed together
• A process that involves using special equipment – repeater pump
• A process that involves more than 1 person to complete
• A process that takes longer than all of your other procedures

2. How many units do you compound when you perform this compounding procedure?

This is important because honestly, if you’re making 700 vials of something, realistically, this is what your media fill should look like also. I know, this sounds crazy. But it’s true. Why? Do you understand exactly what a media fill is intended to demonstrate?

A media fill is a simulation of one of your most difficult compounding procedures to demonstrate several things actually. Primarily, it’s to demonstrate the competency of the operator. But let’s not stop there. Think about it. In a single simulation, if properly arranged and executed, can tell you:

• If your operator is using proper behavior and aseptic technique
• If you engineering controls are working as they should
• You procedure itself has issues – maybe there’s a better, easier and more efficient way to do the same procedure and a media fill is an extremely low risk way to figure out some of these issues as well – because obviously, no one is going to receive these compounds

Honestly, maybe this list isn’t complete, can you think of any other potential benefits?

3. How many active ingredients are in your most complex procedure and what is used? For example, are you reconstituting 2 ingredients then injecting these into a single IV bag? Are you mixing non-sterile powders in some type of liquid (or several) and then using a repeater pump and filter to dispense into vials?

Whatever the answer is to this question, and this is the easy part, you are simply going to remove the active ingredients and replace them with growth medium. So, if you’re using API powders, use tryptic soy broth powder. If you have vials that you’re reconstituting, start with vials that have powder media, reconstitute with water then continue the rest of the procedure as you would normally (and it is NOT difficult to buy TSB powder, put it in vials – sterilize if you need to – then perform everything else as you would in your actual compounding procedure). If you are using multiple mini-bags of an active ingredient and putting them into a larger bag, buy mini-bags of the same volume, put growth media in them.

OR, you can buy mini-bags already made with media – these are not difficult to find, MULTIPLE manufacturers have these. So I don’t show bias, simply google: “tryptic soy broth mini-bags” or “tryptic soy broth” – but just to give you a few more clues, buy these from the original manufacturers and save money, if possible. Some manufacturers only use distribution networks so in those cases, you cannot buy direct. BUT, I will say, most manufacturers you can buy direct. Okay, you twisted my arm, here’s a few of them: BD, biomerieux, BioMed QC, Hardy, QI Medical, Millipore Sigma. I only put in actual company names because I think many people buy from distributors and pay more than they should.

Okay, easy right? Think about whatever and wherever your active ingredients are in the process, what you do with them, what form they’re in, then just simply replace those with literally the same exact dosage form type, but the active ingredient will be growth media. Very easy.

4. Last question. What does the process look like exactly? What are ALL of the steps? What equipment is used and how many people are required to do this from beginning to end?

Okay, if your process takes more than one person, remember this is a competency assessment for ONE person, but if there’s more than one, the person being assessed needs to be the “point” person for the procedure. They call the shots and are the one primarily responsible for telling everyone else what to do. Again, this is only if your procedure necessitates more than one person.

Just to summarize everything, you are literally duplicating your most difficult, complex process, substituting your active ingredients with growth media. That’s it! No más.

Bonus round

Now, there’s some things you can do to make this more complex or difficult and I encourage you to do some or all of these.

What other things might be going on during a “normal” day that might make your day just slightly more complicated or difficult? Why not schedule your media fill right after or before lunch? Maybe schedule it at the end of the day, obviously when people are tired and just want to go home. These are good simulations to do because THAT’S LIFE! This is how the real world works. It is better to use a media simulation as a way to iron out issues with your process or personnel because in all reality, no harm, no foul. Okay, so if someone fails a media fill, no one is happy. But think about what you may have gained. During your investigation of what actually went wrong, you should be able to see some of the potential problems with the process or operator. Then, fix them. Obviously, if you can fix them for the sake of passing a media fill, it should also be a lesson for you to fix the actual process also.

Media fills, and for that matter, glove fingertip, environmental monitoring etc., are NOT meant to be punitive. These are quality controls that are literally done with the intention of finding potential hiccups in order to correct issues before they reach the end user. These are so much more than a checkbox for complying with <797>. And it is a shame (and waste of time) if you’re manipulating these extremely important QC steps so that you ensure everyone is always passing with flying colors. If this is what is normally happening at your facility, it’s never too late to change and start fresh so that you can actually GAIN something out of these requirements.

Honestly, there’s several more things that I could throw into the mix here, but in its most basic form, this is how a media fill is determined and executed.

But wait, there’s more…Let’s save some time and money (potentially) and also do a smoke study at some point during the media fill. Maybe reserve this for the end and segregate whatever media was compounded while there was smoke in the PEC. But do you know how to do a smoke study? It’s not too complicated, easy to do and only requires some knowledge, a couple pieces of equipment and if you’re really wanting to do it correctly – a written report. I’ll tell you all about it in the next post.

Until then…thanks for reading!