becomes first ISO 9001:2008 and cGMP certified manufacture of eLiquid in the United States!

Discussion in 'QC Research and Testing' started by ISO_GMP_USA, Dec 5, 2011.

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    ISO_GMP_USA Guest just became the first and ONLY ISO 9001:2008 and cGMP certified manufacturer of eLiquid in the United States.

    Now that is the leader in quality! Certifications
  2. BardicDruid

    BardicDruid Ultra Member Verified Member ECF Veteran

    They're liquid is expensive and no where on the site is the ingredients listed, trust them if you want too. A laboratory cert is meaningless without knowing what's in the product, after all what are they hiding, remember BE?
  3. oldsoldier

    oldsoldier Retired ECF Forum Manager Verified Member ECF Veteran

    Supporting member
    While I applaud the OP for going the extra mile to get certified, I think the people that frequent this forum are looking for more information. The ISO standards cover a lot of ground, They would probably like to hear what the OP certified in and how that applies to the manufacturing and QC process.

    This is an ideal opportunity to address concerns among the community and stand out among your peers. Please consider expanding your information from a press release to a more complete discussion of non proprietary information so that the community can benefit.

    ISO_GMP_USA Guest

    Thanks oldsoldier! We'd love to answer questions. You had a couple in your post.

    1-ISO covers a lot of ground, for sure. It can cover any business in any industry. It certifies a quality management systems not products. That said, it requires the company being certified to address all applicable industry regulations. This is why we integrated GMPs into ISO. In order to be ISO certified we had to have our GMPs (Good Manufacturing Practices) audited.

    2-The scope of our ISO certification (what the business does) is "design and manufacture of e-liquids for electronic cigarettes and the filling and distribution of related hardware."

  5. TTK

    TTK Super Member ECF Veteran

    I have ordered several bottles of e-liquid from AEL and , no, they are not the cheapest e-liquid you can find. But it is very good, IMO. Their VG e-liquid is 100% PG free as stated on the site. They frequently run over production sales where you can get 60 ml bottle for $15, and if it a flavor you like, that makes it a steal for a USA E-liquid. They also have a 30 day money back unconditional guarantee on their e-liquid, even if you simply don't like the flavor you bought. So, I do think they have a lot going for them.
  6. Killjoy1

    Killjoy1 Ω Destroyer Verified Member ECF Veteran

    Supporting member
    Well, I have a couple. These apply to not only you but to any other vendors that follow suit with certifying standard work practices. Basically, certifying your working standards does not necessarily guarantee quality in all aspects. I don't mean that as an insult or in any way negative to your business, just mentioning it for discussion :) Where I work, we have more certifications and standards than any one person can keep track of, but many of them can still be adhered to completely and result in a product that doesn't pass final QC.

    On to my questions (and again, this is not just for you and in no way is meant to be an attack, but just something to think about/discuss for all vendors):

    Do your standards cover the allowed percentages of potentially hazardous chemicals in the finished product? And which ones?
    Min and max quantities of all non-hazardous components for QC purposes (consistency of product)?
    Do they cover practices concerning hygiene?
    Packaging processes to avoid contamination at that late stage?

    These are the sort of things that I think the general vaper wants to know, without giving away trade secrets of course, and I applaud you for implementing standards in this way

    That's just my :2c:
  7. TTK

    TTK Super Member ECF Veteran

    Exactly. I have asked those questions to all of my e-liquid vendors, including AEL, but I have never received an answer. I usually get more promotional material. Hope you are more successful, but don't hold your breath. If you do get answers that show they address all of those areas, AEL will be the only company I buy any e-liquid from.
  8. TTK

    TTK Super Member ECF Veteran

    The silence is deafening, isn't it?
  9. Kurt

    Kurt Quantum Vapyre ECF Veteran

    Supporting member
    I don't see anything about QC, just that the management system meets a set of requirements, and approved by a registrar. The main point of this QC forum is because there have been problems with nicotine levels. What is being done to ensure that the levels are what they say they are?

    The liquid is seriously expensive, but if it is always spot on, that is good.

    But why does the 60 mg unflavored liquid look so yellow at the top, and colorless at the bottom?
    HUGE 40% Savings on 500 mL DIY eLiquid - 60 mg/mL Nicotine

    Perhaps it was not shaken before the photo was taken? Is this liquid being made in the retail bottles from pure nic and PG/VG? It looks like it. I mean this is a steady gradient of increasing yellow, which cannot happen if it is from a well mixed larger batch.

    I would test it, but it looks like they only sell one size and nic level for unflavored, and it's out of my price range at the moment. Not sure how much the one reviewer of it did any price comparisons, but I think this is the most expensive e-liquid I have seen anywhere, even on sale.

    Hate to be critical, but this is the QC forum, that is what people here want to know about.
  10. TTK

    TTK Super Member ECF Veteran

    I don't buy it based on cost comparisons. I buy it because I like it, as I do e-liquids from other vendors. It is actually not as expensive as, say, Totally Wicked's Red Label, for example, and I buy that too. I noticed the same gradient on the liquid on sale, but don't put much concern to that, since you are supposed to shake any liquid before you use it.

    I am disappointed that they have not responded to the QC questions put forward. But I am not surprised, just look at the responses to the Manufacturer's QC thread. Completely empty.

    ISO_GMP_USA Guest

    TTK - Appreciate that! Do you have the 877-367-9988 number memorized? ;)

    ISO_GMP_USA Guest

    Killjoy1 -

    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!

    ISO_GMP_USA Guest

    TTK- FYI I just responded to Killjoy1's post, let me know if you have questions! Thanks!

    ISO_GMP_USA Guest


    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

    Thanks, Kurt!
  15. TTK

    TTK Super Member ECF Veteran

    Thank you ISO_GMP_USA. Going to order some more AEL liquid right now.:toast:
  16. Killjoy1

    Killjoy1 Ω Destroyer Verified Member ECF Veteran

    Supporting member
    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)
  17. Kurt

    Kurt Quantum Vapyre ECF Veteran

    Supporting member
    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.
  18. tiburonfirst

    tiburonfirst They call me 'Tibs" Verified Member ECF Veteran

    Supporting member
    nice to see at least one vendor responding .......

    but a pity that this subforum gets so little traffic. maybe not enough drama?????????
  19. calsax

    calsax Deadhead at large Verified Member ECF Veteran

    Supporting member
    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
  20. Str8V8ping

    Str8V8ping Vaping Master Verified Member ECF Veteran

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