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The Bar Gets Raised (again)

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ISO Certification Vaping Industry E-lliquid

 

It feels like only yesterday that the idea of “lab-made” liquid was something of a luxury and a benchmark for quality.   Back in those days, it wasn’t all that uncommon for liquid to be made in people’s basements or in the back of shops, and to some extent, that’s still happening.   Today, however, it's much less prevalent as the whole industry has grown into making liquids in more controlled environments.  What’s even more compelling is that this shift didn’t occur because of the government forcing the industry’s hand.  Smart entrepreneurs, sensing impending regulation, moved to raise the bar themselves and to separate themselves from the competition.  You’ll see terms like ISO 8, pharmaceutical grade, and GMP thrown around and you may be wondering what that means when it comes to buying your next bottle.  As a manufacturer of liquids since 2013 I have seen this transition first hand and am going through some of these of these as we speak so hopefully I can shed some light on some of these acronyms and help you make a more informed purchase.

ISO 6/7/8

You’ll see this one a lot, and there’s actually two things to explain here.   The first is the word ISO.  It stands for International Standards Organization.  ISO is an independent, non-governmental organization made up of the standards bodies from 163 countries.  When a need for a standard is identified experts from around the world convene to form technical committees and working groups to draft it.  Standards can be for anything and everything, from Quality Management, Information Security, Energy Management to Occupational Health and Safety.  The idea here is that you have a global standard that can be agreed upon wherever you are in the world.  In this particular example, the standard being referenced is for Clean Rooms and this standard goes from Class 1 to Class 9, with Class 1 being the cleanest.   The reason you probably see this one the most is that it’s relatively easy to obtain.  Clean rooms, aside from needing to be clean at the time of testing, are given their classification largely based on the number of air exchanges per hour and particulate size.  All you really need to do is get a strong enough filtration system (typically can be had for under 10k) and pay $1500 bucks or so for the 2-hour test and you’re good to go.   To be honest, on its own this standard doesn’t mean a whole lot.  It tells you that the liquid was made in a clean spot at the time of testing, but says nothing about the company’s processes for ensuring your liquid was made properly on an ongoing basis.

 

GMP

Stands for Good Manufacturing Practice and has far more impact on whether or not your liquid was actually made well.  These guidelines are enforced by different agencies in different countries (the FDA in the US, MHRA in the UK) and cover a wide range of quality measure including cleanliness and environmental controls, manufacturing processes, procedure documentation, and record keeping.  This goes way beyond just having a clean room and makes sure that the company is actually producing their products in a consistent, quality controlled, traceable way.  There are far fewer companies that meet and adhere to these standards then there are clean rooms out there at the moment, but that will likely change as the industry continues to mature.  Where things get a bit tricky here is that GMP can only be enforced when the industry has reached a certain point in regulation.  Unregulated industries, by their nature, do not have any enforcement in place yet so getting GMP stamp would be difficult in most parts of the world.

 

ISO 9001

This is the ISO equivalent (roughly) of the GMP standards in place in each country.  Both are quality systems and both require rigorous maintenance.  This standard is global as discussed earlier and can be obtained today for e-liquid businesses.  My company, Vape Brands International, is in the middle of implementing this standard and I can tell you that it’s quite a pain in the ass but well worth it.  Whereas getting our ISO certification for our clean room took no time at all, going through ISO 9001 is a process and a complete change in the way we do business.  The standard, like GMP, covers quality control, documentation, traceability and cleanliness and its ongoing in nature.  That means you can’t just call in a tester to pass you and get on with your day.  You need to adopt the standard into everything you do and have internal mechanisms for enforcement if you want to succeed in obtaining and maintaining it.   We viewed the move into ISO 9001 compliance as a forward thinking business move as compliance to IS0 9001 almost certainly means you’ll be in good shape for whatever the enforced GMP standard looks like.

 

So what does it all mean?

This depends entirely on how much you care, I guess.   If you’re not terribly concerned about where your liquid comes from or how its made, then it likely means nothing to you.  If these are things you think about then looking for them or asking about them when buying a bottle is probably a good idea.  The other impact here is in price.  These standards are not cheap, and that money has to come from somewhere.   I’ve often heard the DIY community lament how overpriced liquid is when compared to making your own stuff at home and there’s no doubt that this is true.    The fact is that quality costs money and if you’re dealing with a company that has ISO or GMP standards of any kind you’re definitely paying for that with each bottle you buy.   Implementing both an ISO clean room environment and ISO 9001 standards is easily hundreds of thousands of dollars, if not millions depending on what you do and these are costs that your local vape store brand doesn’t concern themselves with.  

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  • Beju Lakhani
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