LOVE the questions!
Do your standards cover allowed percentages of potentially hazardous chemicals in the finished product and which ones?
YES! Our eLiquid ingredients are: a base liquid (VG or PG), food-grade flavoring, and nicotine. Nicotine is a very dangerous chemical in pure form. Before we accept a shipment of nicotine it is tested by a 3rd party lab - the test is called identification and purity. Obviously this is to ensure that we get exactly what we order. Some manufactures would immediately accept nicotine that is accompanied with a certification document and consider this an extra step, to us, it allows us to sleep at night, pure nicotine is CRAZY dangerous.
We know that in the UK 75mg/mL concentration of nicotine is considered a toxin. We sell a MAX of 60mg/mL diluted in a base liquid (PG/VG) for DIY use only. The MAX we sell in ready to use eLiquid is 36mg/mL. We then look at the eLiquid manufacturing process. We manufacture bottles of eLiquid daily following our written processes. These processes are developed using GMP guidelines, including assessment of critical control points. One critical control point for us is when nicotine is added to each bottle (is the "riskiest" step). Assessing the risk is first having tested raw product, using calibrated pipettes to dispense, sanitation procedures for all lab-ware, sanitation procedures for the lab as a whole, storage procedures, lot number tracking and traceability, pest control procedures, and many many more. These processes are then verified. There are go-no-go tolerances for nicotine, this literally is fractions of drops that impacts the percentage of nicotine that is added to the intended specific bottle, respectively. Answer is yes.
Min and max quantities of all non-hazardous components for QC purposes?
Absolutely. Processes for adding the flavoring and base liquid are roughly the same as explained above.
Do they cover practices concerning hygiene?
Also as notated above hygiene is covered in the GMP standards - literally pages of the standard are dedicated to hygiene.
Packaging processes to avoid contamination at the late stage?
I am a little unclear with this question. Bottles are packaged in tamper evident packaging so the recipient knows if the package has been opened. Bottles will never leave the lab without being sealed, and they are not unsealed until received by the customer. And believe it or not, again these processes are all documented
I hope this answered all of your questions, feel free to ask more!
I think I answered most of your questions in my post reply to Killjoy1. I do want to clarify a couple things in your post though.
ISO 9001:2008 refers to the management system of a company, inside the ISO 9001:2008 standard it states essentially that the company will abide by other standards applicable to the industry (this is NOT a direct quote). We INTEGRATED GMP standards into our ISO certification. ISO/GMP are all about QC, it address how you can prove that what you are making is what you say you are making. It goes even deeper to address things like pest control, hygiene, calibration, air handling, window coverings, light coverings, lot traceability, product testing, purchasing/receiving processes, product contamination, shipping, and a lot more. If you want to read the GMP standard (pretty dry but interesting stuff) here is the link: CFR - Code of Federal Regulations Title 21 The ISO 9001:2008 is >$100 and not something I can reproduce legally.
The question of why the pictured DIY eLiquid is separated/colored. Nicotine when exposed to air will generally tint. As eLiquid ages it will generally tint, or turn colors even if very slightly. Using a base liquid like VG will also, as an eLiquid sits tend to separate from the lighter (weight) ingredients, this is why you will typically see "shake well before use" on eLiquid bottles. Just a side note and a very valid point that you have brought up is the question of how to package DIY eLiquid. Obviously packaging DIY eLiquid in clear containers would be a benefit to the customer so they can see if the eLiquid is separated. If the bottle were say, white, how would you ever tell if it is separated or colored?
You asked if the eLiquid was made from pure nicotine and VG/PG - Answer is yes. Nicotine is tested for identification and purity and VG/PG are USP grade with certification documents.
You stated that we only have one size DIY - we actually have 15mL, 30mL, 60mL, 500mL in DIY, starting at $9.99. Here is the link: Mix-Your-Own, Do-It-Yourself (DIY) - American eLiquid Store
Thank you ISO_GMP_USA. Going to order some more AEL liquid right now.
Last edited by TTK; 12-07-2011 at 07:16 PM. Reason: typo correction
All right, that is more the level of information that I think people really want to know. More questions? well, I don't really have any, I pulled those out of thin air just by way of example of the sort of QC issues consumers want to be informed about
I suppose there are other facts and figures that some people may ask for, as well. Things like acceptable margins (tolerances +/-%) of ingredients in the finished product and maybe any particular compounds found in flavorings that some have raised concerns over (such as diacetyl, etc)
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ISO, thanks for fielding my questions!
A couple more points and questions:
"Identification and purity" is not generally the name of a test, it is the results of the test. Is this a GC-MS analysis? This is good for the pure nic, to know if it of high quality.
But what are you doing to ensure the nic levels being sold are actually what is in the bottle? I am finding that even if they are using a volumetric syringe correctly, nic levels are not always coming out right, and are often 10-20% too high. Most vendors are not doing titrations or other more expensive tests to verify correct nic levels of retail liquids. What are you doing?
I am impressed with the lengths you are going for hygiene, airflow, nicotine purity, and general safety and care. These things are all very good, and extremely welcome. It is the nic levels themselves that catalyzed this forum and general awareness.
Deciding not to smoke is one thing. Forgetting to smoke is a different animal altogether.
nice to see at least one vendor responding .......
but a pity that this subforum gets so little traffic. maybe not enough drama?????????
I work in Quality in an ISO13485 registered Medical Device company, and while ISO certification doesn't specifically guarantee that any specific product meets any specific standard, it does mean that they follow cGMP, and have the required processes in plaace to produce consistent product, and documentation of it. All other things being equal, the overhead of maintaining certification means the cost goes up. I will be checking this mfr out, and if their product meets my requirements in other ways (flavor, etc.), I will use them with the expectation of always getting consistent product. IMHO
it requires the company being certified to address all applicable industry regulations. This is why we integrated GMPs into ISO.[QUOTE=ISO_GMP_USA;4717836]
This is what doesnt make much sense to me and thats being certified in all industry regulations when this industry doesnt have many regulations .
WHat regulations do you mean ?
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