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Should ISO Certified Clean Rooms Be a "Necessary Requirement" for eLiquid Vape Manufacturers? No.

Shane Brooks’s insight:

Much is being made in the industry press these days about “contamination risk” and “clean rooms.” Now, let it be known that clean rooms–rooms specifically designed in order to reduce particulate matter in the air–are not bad things.

Most large, industrial concerns have them as a matter of course in order to keep the mass-production of their products suitably aseptic. For the mom-and-pop concerns, however, they do constitute a very high economic barrier to market entry should they become mandatory via regulation.

The local marketplace of competition against multiple small players with small market shares would be eliminated in favor of a national (or international) marketplace of large players with large market shares, and experience shows that duopolies or triopolies aren’t much better for consumers than monopolies.

 

Still, cleanliness. Is that too much to ask? It’s clean, and clean is good! More clean is more better!

 

Depends, actually.

 

Let’s look at your own kitchen, assuming that you’re one of those people who still cook. You probably keep it clean enough for your own use, but I can bet you dollars to donuts that it doesn’t pass anywhere near muster for ISO clean room certification. It doesn’t have to; if you screw something up, you’ll only make yourself sick and have yourself to blame.

The social risk involved with theoretical you, as a stand in for any workaday slob, making some bad eggs is very low. As such, there’s no call for society, via the state, to regulate how clean you personally keep your kitchen.

 

Obviously, this level of regulation is insufficient for anyone intending to make things for other people, since if a slob-kitchen becomes a business then all sorts of other people could get hurt should it become an epicenter of some sort of sanitation-based outbreak.

That’s why we have city and county and state health inspectors who drive around to restaurants and inspect their kitchens. Note how restaurants and bakeries, with their wider consumer base and higher risks, are kept to higher standards of cleanliness and the like, but it’s highly unlikely that your local Taco Bob, for all its cleanliness, has an honest-to-god vacuum-isolated clean room. It still doesn’t have to, since the scale of its potential health risk doesn’t justify requiring such expense from operators.

 

Now let’s look at the local industrial bakery. We’re not talking about people waking up early to put loaves in the oven and bread on the shelves, we’re talking about mass production of plastic-wrapped loaves that go out to grocery stores throughout the state.

Here’s where you’re going to start seeing clean rooms at certain parts of the process (and even then, only parts) because the customer base is running into the hundreds of thousands to millions. Each loaf of bread is a roll of the die, and enough die rolls are being made against slim odds that those odds are no longer negligible.

Since contamination is not truly random but usually a failure in process, if an industrial bakery screws up, they’re going to make loads of people sick unless quick action is taken to contain the bad batch, a la some of the food scares in recent years.

 

Next step up is the commercial bottling plant. It too will have low-grade clean rooms in the bottling stage for the same reason, but these clean rooms will be ‘better’ and more expensive than those in the bakery because they have a national distribution. Millions to tens of millions use the output of this one plant, so it has to take special care with its cleanliness.

 

Next are pharmaceutical plants with international reach and that are working with extremely potent ingredients. Not only do they have to be clean in order to keep the occasional germ out of their products, they need to be cleaner still to make sure that they don’t adulterate their products with any other of their products given the potency involved. When you’re handed a one-gram pill of which half a milligram is actually active ingredient, that should be indicative of just how powerful the stuff is.

 

Now let’s corral this all back to the vaping industry. It’s definitely not pharmaceuticals; if someone mixes in black honey flavor instead of regular honey flavor, no one is going to panic and call the CDC and FDA and FEMA and ask them to institute Contingency DEATH CAMPS.

If someone does panic and ask for Contingency DEATH CAMPS along with a Directive 7-12 on the side, the people in charge of responding to public health risks are just going to roll their eyes and hang up the phone. If they’re particularly nice, they’ll point out the number of the local health inspector and kick it down the line that way, as local concerns should be locally regulated.

 

This brings us back to the regulation question. Regulation scales, in a reasonable world, to risk. Massive industrial concerns serving millions have to be tightly regulated to ensure that their quality controls, constantly tested in millions of opportunities of failure, work.

Tiny concerns that serve ten at most don’t really require regulation at all since they have fewer opportunities to fail and even one screw-up will shut them down (probably because the screwer-up will have made /themselves/ sick).

Things in the middle have proportional regulations, and if we can expect a restaurant that serves thousands throughout the year to be acceptable without clean rooms, we can expect the same from mom-and-pop vape mixers.

Their certification doesn’t come from ISO but from the county health inspector’s “A” placard in the window, and that’s fine since tighter process controls wouldn’t actually buy anyone any additional safety at such a small scale.

 

Some concerns may go clean room anyway as a market discriminator, since it’s pretty easy to sell that having 20 parts +/- 0.001 parts lemon extract in a mix is better than 20 parts +/- 0.1 parts (how can you tell how others mix their products and the mix is exactly what they claim?).

That’s fine; it’s a perfectly reasonable up-market option and is pretty standard operating procedure to charge higher prices on people who don’t understand the dance between manufacturing tolerances and acceptable production variability (protip: any tolerance tighter than the acceptable variability is excess time, cost, and effort). It should also be voluntary since it’s an up-market discriminator not actually required to maintain product safety at publicly acceptable levels.

 

In the end, cleanliness in excess of what’s necessary isn’t in and of itself a bad thing and it would be silly to argue otherwise. However, excessive regulation in cleanliness quickly becomes silly once one thinks in suitable analogs and starts imagining the local Taco Bob patty-flipper working in a hermetically sealed room while wearing a spacesuit.

Excessive regulation that doesn’t actually buy additional safety due to the scope of the operation only serves to increase the costs of entry and operation, which limits market players to larger corporate entities who can not only pay those costs and extract the profits from the market.

For the past thirty-five years we’ve seen that trusting megacorporations is not only an exercise in futility but actually dangerous in terms of macroeconomics and society.

 

The less forgiving amongst us may consider that to be part of the game plan. If vaping is going to be the next big market, it’s easier to capture it via regulation than by actually outcompeting other products, and it’s easier to capture it via regulation if one’s got money to throw at lobbyists and use the regulations as loss-leaders to force smaller, better players out of the market.

Maybe thirty-five years ago we’d consider that cynical, but we’ve seen that cycle play out enough times over the past quarter century that someone amongst the Powers That Be somewhere is probably playing that angle.

 

Always demand quality, yes. Always demand safety in terms of acceptable risk, yes. Be careful of how it’s demanded, though, since that old devil the Law of Unintended Consequences has a real knack for giving people literally what they wished for.

Regards,
Secret Agent: Timperator of Man
Anon Vapes

Should ISO Certified Clean Rooms Be a "Necessary Requirement" for eLiquid Vape Manufacturers? No.
Source: Electronic Cigarette News

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