I’ve had a few people contact me about the process for cleaning up a hazardous drug per <800>. It’s slightly different than what we’re used to than our typical clean and disinfect. For a little refresher on how to properly do that check out THIS POST; a couple quick things to remember:
- Cleaning and disinfecting are two separate steps and require different agents; cleaning being the removal of debris and disinfection is the application of a disinfecting agent.
- The mechanical action of WIPING has quite a bit to do with cleaning at the very least; do this with purpose and typically in one direction (even when wiping off items with isopropyl alcohol that are being brought into the cleanroom)
When cleaning a hazardous spill there’s a couple more steps you have to add to ensure that the hazard is properly being removed. A table directly out of USP <800> summarizes this fairly well:
- Deactivation: renders the hazard inert or inactive. This is done using an EPA registered OXIDIZER; peroxide formulations (including peracetic acid and peroxyacetic acid) or sodium hypochlorite
- Decontamination: removal of the hazardous residue. This may include alcohol, water, peroxide or sodium hypochlorite.
- Cleaning: removal of organic or inorganic material. This is accomplished using a germicidal detergent.
- Disinfection: Destruction of microorganisms. Use an EPA registered disinfectant.
Okay, let me just say that I’m not being paid by any company to talk about their products; but sometimes people want specifics so I’m going to try and be fair and let you know there’s many different companies that have their own variation on these chemicals. While they all may say theirs is superior to the next, the most important thing is that you’re doing it properly and with the correct agent for the step you’re trying to perform. TO BE CLEAR: I’m not endorsing any one product.
Here’s a quick list of chemical suppliers that are reputable (in my opinion) and in no particular ranking order:
- Veltek (VAI)
I’m sure there are others that are also reputable that aren’t on this list, these are simply the ones that I personally have used and feel very confident in dropping their names.
Here are the various sites for each company where you can find their oxidizers. Remember you’re looking for hypochlorite or peroxides.
Texwipe – Texcide
Contec – Peridox
This is simple; just use the above links…or use sterile water or alcohol! Easy, done.
Disinfecting agents…if you’re wondering about these check out the post I already referenced HERE; there’s a few different types and I’m simply going to list some from each company. The only thing I’ll note here is that some of these are ONLY available as concentrates which means you must dilute which involves a little bit of chem lab time. They’re not necessarily difficult to mix and dilute but it’s another thing that needs to be documented and accounted for. One other thing to mention, you could use an oxidizer as a cleaning agent as well however they will need a RINSE with alcohol as they will degrade surfaces!
Steris – Process NPD, Coverage Plus and Vesta Syde
Texwipe – TexQ
Contec – PREempt
A few of the above agents are touted as being germicidal disinfectants (or even germicidal detergents – detergent being the cleaning agent) and can be used as a disinfectant as well.
Veltek (VAI) has a product called wipe down 1-2-3 which is an easy all in one solution. This probably isn’t the only one on the market, it’s just the one I’m aware of. Of course you can buy each of the solutions in the Veltek separately and create your own kit too.
Peridox from contec would be a peroxide and germicidal detergent, which theoretically you could use this 4 times for deactivation, decon, clean and disinfection then follow up with IPA (because it will degrade surfaces).
One thing that many people don’t think about necessarily is the substrate (wipe material) they’re using with the particular agent. Is that material compatible with the agent in that it isn’t breaking the wipe down and possibly leaving your surfaces worse off than they were before wiping?! I challenge you to ask the company that provides the agents if they’ve done studies with their product and various wipe materials. If they do…awesome; GET YOUR HANDS ON THEIR STUDIES.
Other things to consider
There are many companies that make pre-saturated wipes; Berkshire has some really nice wipes that they’ll be producing with various concentrations of peroxide. The idea here is that the companies that have these pre-sat wipes have at least done some testing with the materials they’re using and the chemicals they’re saturated with. Aside from that honestly the wipes I’ve received from Berkshire are the nicest on the market that I’ve come across. To be fair, they’re not the only ones that saturate wipes with cleaning agents Veltek also has a few of their products in pre-sat wipes as well as Contec.
Since we’re talking about wipes I have to mention one other product I’ve come across; Benchmark’s Suite Wipe. The material is almost like microfiber, it cleans ridiculous well but the most impressive part is that it touts a less than 0.02% carry over; that is theoretically you can use it over and over again and the wipe won’t cross contaminate from surface to surface. However, I say this with caution as this isn’t a “sham-wow” miracle product meaning it shouldn’t be used for hours upon hours, day after day to “test” that.
Let thing to consider: have you done your own testing on your methods for Deactivation, Decon, Cleaning and Disinfection? How would you even go about performing this kind of testing? Is it necessary? If you’ve read my blog before I say this quite a bit: if we’re going to do something in a particular way we should be proving it works. This is simply the idea of validating our processes and procedures and it’s the major difference between compounding pharmacy and manufacturers. The way that a GMP facility would prove their cleaning methods work is doing a cleaning validation. This is more or less a study proving that after the process they’re using for cleaning (with particular agents, materials and methods) is able to remove debris and disinfect. In the case of removing hazardous chemicals you’d need to prove the hazard is no longer there as well. There are labs available that can assist you with performing these kinds of studies. The one that I’ve come across:
The Center for Pharmaceutical Cleaning Innovation – Owned and operated by Andrew Walsh who is TRULY an expert in cleaning validations. He’s a microbiologist by training but has been doing these studies literally for decades for big pharma. By the way he also teaches this stuff! I’ll be attending one of his classes in the near future.
While USP <800> doesn’t require us to PROVE our cleaning procedures for hazardous drug spills, I think this might be coming. Right now, we have no studies that tell us what exactly “clean” means. How do we know, based on quantifiable limits, that we’ve properly deactivated, decontaminated and cleaned that spill? It’s a MAJOR flaw in USP Chapter <800> that needs to be dealt with over the next 5-10 years (the next 1-2 cycles of USP committee experts). This isn’t just important from a worker safety standpoint but this also comes down to cross contamination. If we don’t have any numbers, any data, to PROVE that our drugs that we compound aren’t left on any of our work surfaces so as to NOT contaminate the next compound? The answer is out there, are you ready to answer that question?
Recently, I had a compounder tell me that they were visited by the FDA and the inspector asked the question, “what is your contact time for deactivating any HD spill?” They turned to me and I didn’t have an immediate answer for them. But after doing a lot of research (8 hours), I figured out the answer. I detailed what I found in a video, see below.
There’s a lot that goes into this, figuring out how to definitively say our cleaning procedure is working and we base that on quantifiable limits on a drug to drug basis. Each drug is going to be different. Think about this, fentanyl versus acetaminophen. It’s a lot more critical that we ensure fentanyl is cleaned from a surface than acetaminophen. Same idea with any drug, not just hazardous drugs. We need to figure out the quantifiable limits that tells us, “yes, you have sufficiently cleaned this surface of this drug.” It takes quite a bit of research and some calculations and testing on our part, but it’s the right thing to do for the safety of our patients. More to come on this in a future post. The answer is out there, are you ready to answer the question the FDA, state board of pharmacy is going to ask? Like I said, more to come…stay tuned on this!
There are many ways to accomplish the same thing honestly with various combinations of products; I’ve mentioned a bunch of options. Get started on developing your own processes and procedures, find out what works then write the SOP (train and retrain your operators to ensure consistency) and do that every single time with the documentation to prove it.
About the author:
Seth DePasquale is a Board Certified Sterile Compounding pharmacist and former co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.