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Hand Sanitizer: Real or Not Real
A lot of companies have been getting into production of hand sanitizer lately. We’re talking about distilleries, breweries, and other businesses that handle solvents. They have good intentions, in that they are trying to be as helpful as possible in light of the current crisis. We ask this quesiton all the time in ISO-HELP.com. But, like in all cases where vast amounts of money are involved, it is possible that people are getting into it and are not especially interested in being helpful.
Hand Sanitizer: Real or Not Real
I ask this question, or variations of it, in every ISO audit. The fundamental question of quality systems in general is: good or not good? Is this product (or service) good, or not good, and how can you tell? Are the employees trained or not trained? Are the process inputs real or not real? Work instuctions? Current or not current? In fact, that is one of my six rules:
The follow up question is: “How do you know?” and a lot of process control is about asking this question. And if the answer is “I don’t know” the follow up question is; “How are you going to find out?”
Hand Sanitizer: Real or Not Real
Which leads us to the following story. I occasionally work in distribution, and the other day, several drums of hand sanitizer came in looking like this:
Those experienced in distribution can see right away the first problem. Most hand sanitizer has in it alcohol. This can be either isopropyl alcohol, or ethanol. These solvents are cheap enough and safe enough to kill germs that are on your skin without being absorbed.
A third kind of alcohol, methyl, is not recommended for this purpose because it soaks into your skin and makes you sick.
But, both of these two alcohols are also flammable. So, when a shipment of 55 gallon drums comes in the place without any placards, it is in violation of DOT requirements. Why this is important is that there is a greater than zero chance of this stuff catching fire, and that is dangerous.
So that’s apparent violation number one. The answer to the question Hand Sanitizer: Real or Not Real still can’t be answered.
Hand Sanitizer: New Rules
Earlier this month, the FDA and DOT waived a lot of the rules on Hand Sanitizer. It basically says that the production of this is so important, they are accepting additional risk to get it produced, shipped and distributed.
The revised rules are in this document:
During the Public Health Emergency (COVID-19) Notice of Enforcement Discretion
It basically says that in quantities greater than 8 gallons, you are not off the hook from the flammable placard. So, it’s still a requirement.
Problem #2: The SDS
There wasn’t one. There is supposed to be. In it, it should have told you not to put this material next to a heat source.
The employees are supposed to be trained in Hazmat, and part of that basically says “Don’t receive stuff without an SDS, it might be flammable.”
Problem #3 Incorrect Documentation
Here is the actual SDS that was faxed in response to the request for it. There is a bit of a problem.
Production Methods
Come to find out, there is a new guideline on production methods for hand sanitizer as well. It basically says “if you want to start producing hand sanitizer, you have to do so in a controlled manner.”
https://www.fda.gov/media/136289/download
This should be a familiar phrase to the ISO people.
It says you need to formulate the material using USP grade materials. It specifies the formulation (which makes sense, because it allows you to waive all of the skin testing requirements). You have to test the material (using a hydrometer) to make sure you didn’t leave anything out.
If you want to compare the formulation to the one in Section 15 of the above SDS: Do you see the problem? The formulations don’t match.
PS: The glycerine in this formulation is as a moisturizer to keep your skin from drying out.
The formulation at the bottom is the one specified by the FDA above, but the one at the top is different. The label on the drums is the required label, which has the FDA-specified formulation.
Which one actually happened? What’s the reality?
Scenario #1: Hand Sanitizer: Real or Not Real
Here is one theory on what happened:
The company selling the above material is just a distributor. They were already selling hand sanitizer with Aloe. When the opportunity arose, they found a temporary supplier of this stuff. That supplier, whoever they are, used the correct formulation. One of the two companies got in a hurry and screwed up the SDS.
People will get their hand sanitizer, it will be good, and everyone will be able to focus on their other issues.
Problem #4: Lack of Traceability
To be perfectly fair, the document does not actually “require” the company to put the batch number on the drums. Also the word “should” is used throughout which reduces the clarity of whether something is a requirement or not.
In fact, there is more lack of clairty. It says “contains nonbinding recommendations” in the header. Now what?
But, the question becomes: How do you know they didn’t screw it up? If they did screw it up, what way do they have to recall the rest of the batch?
Scenario #2: Hand Sanitizer: Real or Not Real
Some company that is inexperienced decides to get into this business. They have chemical mixers, a handful of dimwit employees, and some empty drums out in the back.
The plant chemist writes up a temporary formulation on a sticky note, sticks it on the mixer, and tells the operator to start mixing.
Formulation Industry Failure Modes
As a refugee from a formulation industry, I can tell you at this point, any of a dozen things could happen. The operator can add the wrong ingredient. The scales could be out of calibration, and the stuff is misweighed. There is a big density difference between glycerine and ethanol anyway, which means there has to be sufficient agitation Otherwise, the glycerine would settle to the bottom and as you loaded the drums, some of the drums would get mostly glycerine. Your hands would be soft, but the virus might live.
Any or all of this stuff could be contaminated. Residue from the previous batch of noxious material could be left in the mixer. Example: Bear Repellent.
The company gets a frantic call, and there is no record anywhere of what went into the batch, who mixed it, and under what conditions. What happened to the rest of it?
There is no containment if there is a problem.
Real or Not Real: Objective Evidence
So here’s your problem as a distributor. Now, you’re potentially liable for anything that happens to this material when you ship it back out.
In the Aerospace standard, it actually tells you that you, the distributor, are responsible for product conformance.
So, where’s your objective evidence that the supplier of this critical material didn’t screw it up? How do you know it is “real?”
Without some kind of lot number traceability, certificate of conformance, or other evidence, you don’t know.
Furthermore, you, as a distributor, may have shipped this stuff downstream to several customers in the supply chain and you have no way of telling who.
Scenario #3: Someone sues you.
Someone buys your stuff. They come down with the virus anyway. Their grieving friends and family blame your hand sanitizer for not protecting them.
You are hauled into court, where you have to prove with a preponderance of the evidence that you did your job. Juries and lawyers are expensive.
Can you do that with no testing, documentation, traceability, or production records?
Scenario #4: We are actually at war.
Some bad guy starts to deliberately produce and sell bad sanitizer. Maybe it is even deliberately contaminated with a known biohazard. Who knows? Someone might want to enhance chaos instead of customer satisfaction.
As we well know, someone sufficiently skilled can do this. What keeps someone from merely fraudulently producing and distributing fake hand sanitizer? We saw an example earlier in “normal times” of fake suntan lotion. Now that people are paying 10X the normal cost for this stuff, there is more motivation to produce knockoff material.
Would someone do such a thing? If we were at war, they might.
Who is keeping track of all of this?
I would go out on a limb that it’s the job of everybody in the supply chain to maintain its integrity.
If you are ISO registered, and your quality policy states your commitment to “meeting requirements” as it should, then it’s your responsibility. You need some objective evidence of conformity, and some identification method to link your material to the evidence of conformity.
IF you’re not ISO registered, you’re not used to thinking like this. A couple of people running a craft distillery wouldn’t know the difference.
If you’re in the Aerospace supply chain, you have four non-conformances, in the same process. Therefore you are subject to a major NC and required to fix it.
Five, if you consider that non-conforming product needs to be identified and segregated from good production. No hold cards on the drums, above.
Chances are, that the problem is just Scenario #1, innocent screwup. If that is the case, a few phone calls will fix it. Most businesses that are established in the hand sanitizer business have lot numbers even on their small consumer packaging.
The chances are greater than zero that the other three scenarios happen. Do with this information what you will. It’s partly my job to tell you this.
The world is chaotic, and there are no guarantees on anything.
