All Juice Manufacturers

[craigb]

Any of the local juice manufacturers care to provide proof of ISO certification for their manufacturing environment?

Or at least proof that the process is completed in a lab environment. Or bathtub, whatever the case may be?

TX.

 

[Zane87]

Thanks for posting this Craig, I feel the vendors who stock juices should be doing a due diligence on every juice they stock, if a customer gets ill from a juice they buy in a store, who takes the blame?

 

[Silver]

Interesting thread @craigb

I do know that @KZOR did an excellent video not long ago where he visited Vapour Mountain's juice lab in Cape Town.

Not sure about certifications but it looks like a clean lab environment to me.

Have been vaping quite a lot of @Oupa 's juices myself for a few years and I havent been sick since I started vaping. So for me I am happy knowing that my regular VM juices are made in those conditions.

Here is the video:


I imagine that several other established local juice makers also have very clean manufacturing environments.

 

[RichJB]

I would imagine that some would be reluctant to divulge where their juice is made. They could post a pdf copy of the ISO certification but that would give the name of the facility which they might not wish their competitors to know. It's also not proof that the juice is made there, it could be an ISO certification that another lab provided to them but which they don't use.

This sort of paperwork is usually handled at an industry/regulator level than a consumer level. If you go into Pick n Pay and ask them for ISO certification of their no name brand ice cream, you are likely to come away empty-handed. It's not really the sort of details that manufacturers/retailers divulge to the general public.

@Zane87, afaik there is no blame. Them's the breaks in an unregulated industry. You can't punish someone for contravening a regulation when no regulation exists.

 

[craigb]

Interesting thread @craigb

I do know that @KZOR did an excellent video not long ago where he visited Vapour Mountain's juice lab in Cape Town.

Not sure about certifications but it looks like a clean lab environment to me.

Have been vaping quite a lot of @Oupa 's juices myself for a few years and I havent been sick since I started vaping. So for me I am happy knowing that my regular VM juices are made in those conditions.

Here is the video:


I imagine that several other established local juice makers also have very clean manufacturing environments.

I remember that video. Its just the whole bathtub juice thing has come up a few times especially recently, so I figure if the likes of @Paulie, @method1, @Oupa and so many other wonderful manufacturers get the chance to chime in, we'll see our reputable manufacturers really are reputable and realize the South African juice manufacturing value chain is top notch already, without regulations.

I have a good relationship with my tattoo artist, and one of the things that disappoints him the most is that not a single customer has asked to see his certification from the health department. But we don't ask because walking into his shop exudes cleanliness and he has a reputation for excellence.

And it's the same with our juice lines, they all have reputations for excellence, and this innuendo that they are unclean are unfair. Has anyone previously directly asked to see certification or proof?

I'm rambling, so I think I'll stop there..

 

[Glytch]

This is a great thread. I think the vaping industry in SA generally prides itself on their transparency. It is one of the arguments FOR government regulation on vaping products as much as we all fear it.

 

[Silver]

I like your points you made @craigb and it is not rambling at all

This is an important issue and one that is well worth discussing maturely.

My view on this is that most of the longer standing juice makers that we know and love on this forum are not in this to make a quick buck (and run). I have dealt with each of them from a forum perspective and for events such as VapeCon. It astounds me how passionate and determined they are. I am not just saying this to flatter them, it is true. These juice makers care so much about their juices and what people think of them. There is very little chance (in my view) they would knowingly be careless in their juice making to the point that it makes us sick from vaping their juices. They try very hard to ensure their product is top notch.

That said, the industry is very young and many juice makers are still relatively small businesses with limited resources. So there may well be situations where better cleanliness or hygeine can be achieved by using labs with facilities that are out of their reach. Or maybe there are machines or techniques that are better but they dont know about them yet (neither am i saying I do). But the intention of most of our local juice makers is very good as far as I can see.

My experience is that i have never gotten sick from vaping. And I have tried a fair amount of juices, both local and international from smaller and larger vendors.

It would however be a good thing if juice makers could strive for improved cleanliness and hygeine on all fronts. And it would be a great pity if, in that quest, a lot of the smaller talented juice makers were "squeezed" out.

 

[Cruzz_33]

I will gather GCC certificates for E-liquids that Drip Society stocks. I will post tomorrow and every time I receive more.

GCC
General Certificate of Conformity (GCC) is documentation where a manufacturer or an importer certifies that the use is for non-children and is applicable to all product safety rules. All US e-juice manufacturers must comply and submit the certified document for each product.​

 

[RichJB]

one of the things that disappoints him the most is that not a single customer has asked to see his certification from the health department

It shouldn't disappoint him. We pay regulators to handle these things for us. Have you ever bought a product from Game and asked to see the results of the testing that the SABS did on the product? Have you ever boarded a Kulula flight and asked to see a copy of the pilot's certification? The assumption by the public is that these quality measures are put in place before a service or product is offered to the public. Which is how it should be. Pick n Pay showing the results of their food contamination testing to one regulator once is a lot more efficient than showing it individually to three million customers.

 

[Glytch]

True. But who regulates the e-liquid industry?

It shouldn't disappoint him. We pay regulators to handle these things for us. Have you ever bought a product from Game and asked to see the results of the testing that the SABS did on the product? Have you ever boarded a Kulula flight and asked to see a copy of the pilot's certification? The assumption by the public is that these quality measures are put in place before a service or product is offered to the public. Which is how it should be. Pick n Pay showing the results of their food contamination testing to one regulator once is a lot more efficient than showing it individually to three million customers.

 

[RichJB]

Currently, nobody does. There may be some generic regulation that pertains to consumable products in general. But it's highly unlikely that everybody is complying with it.

The other thing that one has to consider is that, for the most part, standards are voluntary. ISO 22000, for example, is attained by many manufacturers as a "hey, lookatwotwegot" bragging right thing, not as a mandatory certification. Specifications only become compulsory when there is a public health risk. Which is likely to be the case with juice. I would imagine that ISO will eventually publish a standard for the production of juice and that it will become compulsory. But until then it's the Wild West. Which is why the status quo cannot sustain. The vaping industry's hope that the govt will allow the industry to regulate itself is a non-starter, I'm afraid. It will be regulated.

 

[Vapington]

Great topic. There are a few things that need to be cleared up. Everyone is going on about ISO ratings and what not, but what does it actually mean? Here are our findings:

What is a clean room?

A cleanroom is any controlled environment in which the concentration of airborne particles is controlled to specified limits.

In simple terms:
Classing of clean rooms:

Cleanrooms are classed on two scales.

1. ISO 1 -9 (1 being the best and 9 being room air.)

2. FED STD 209E – ( Class 1 – room air) ( ISO 1 & 2 are not rated on this scale)

These levels are determined by the number of airborne particles present in 1m³ of air of a certain size. The table below is the standard for ISO rating


What this actually means.

To explain this we must look at one ISO rating (ISO 7 for example). If your room is rated ISO 7 it means that there are 352 000 partials per 1m³ of air at 0.5 microns, 83 200 particles per 1m³ at 1 micron and 2 930 particles per 1m³ at 5 microns (the thickness of a human hair ranges between 17 – 181 microns). As you move up the rating those number decrease as indicated in the above table.

FED STD 209E:

This rating system is very similar to the ISO system in terms of the particle size and numbers. The major difference in this system has to do with the cleaning requirements of the room. The following web site has the info for the cleaning requirements for Class 100 and Class 1000: http://www.coastwidelabs.com/Technical Articles/Cleaning the Cleanroom.htm


NCVs clean room:

At NCV our lab has the following specs:

Structure - Our lab is constructed from interlocking polyurethane (60mm thick) panels with a pre-paint chromadex skin, roof and walls all sealed up nicely. With large double glazed glass panels on the front.

Filtration - we use a positive pressure clean room to manufacture our products. This simply means that we keep our room at a constant pressure of 1.5 atmospheres keeping the contaminants out. Our air passes through 3 different filters before being blown into the room. Air passes through two UV Germicidal Lamps to kill off pathogens from the outside air. Air moves into our primary HEPA filter to trap larger particles, lastly the air moves though an F7 Synthetic Pocket Filter.

Equipment - Tables are stainless steel, shelving in main lab stainless steel, multiple overhead mixers are used to blend our eliquid thoroughly, second room is used for assembly of pipettes and caps as well as storage of product components - assembly is carried out on stainless steel table as well. Our juice is sent for bottling and is bottled by Zeftech whom utilize a positive pressure clean room for filling as well. Products are then returned to us for distribution to our lovely vendors.

Ratings/Certification - We intend to have an ISO test of our clean rooms air quality with an external company and will be happy to post our results soon. NCV follows the Class 1000 cleaning program.

Happy vaping!

 

[Faheem777]

Excellent post @Vapington, very informative, thanks!

 

[Vapington]

Excellent post @Vapington, very informative, thanks!

My pleasure!

 

[craigb]

Great topic. There are a few things that need to be cleared up. Everyone is going on about ISO ratings and what not, but what does it actually mean? Here are our findings:

What is a clean room?

A cleanroom is any controlled environment in which the concentration of airborne particles is controlled to specified limits.

In simple terms:
Classing of clean rooms:

Cleanrooms are classed on two scales.

1. ISO 1 -9 (1 being the best and 9 being room air.)

2. FED STD 209E – ( Class 1 – room air) ( ISO 1 & 2 are not rated on this scale)

These levels are determined by the number of airborne particles present in 1m³ of air of a certain size. The table below is the standard for ISO rating
View attachment 101694

What this actually means.

To explain this we must look at one ISO rating (ISO 7 for example). If your room is rated ISO 7 it means that there are 352 000 partials per 1m³ of air at 0.5 microns, 83 200 particles per 1m³ at 1 micron and 2 930 particles per 1m³ at 5 microns (the thickness of a human hair ranges between 17 – 181 microns). As you move up the rating those number decrease as indicated in the above table.

FED STD 209E:

This rating system is very similar to the ISO system in terms of the particle size and numbers. The major difference in this system has to do with the cleaning requirements of the room. The following web site has the info for the cleaning requirements for Class 100 and Class 1000: http://www.coastwidelabs.com/Technical Articles/Cleaning the Cleanroom.htm


NCVs clean room:

At NCV our lab has the following specs:

Structure - Our lab is constructed from interlocking polyurethane (60mm thick) panels with a pre-paint chromadex skin, roof and walls all sealed up nicely. With large double glazed glass panels on the front.

Filtration - we use a positive pressure clean room to manufacture our products. This simply means that we keep our room at a constant pressure of 1.5 atmospheres keeping the contaminants out. Our air passes through 3 different filters before being blown into the room. Air passes through two UV Germicidal Lamps to kill off pathogens from the outside air. Air moves into our primary HEPA filter to trap larger particles, lastly the air moves though an F7 Synthetic Pocket Filter.

Equipment - Tables are stainless steel, shelving in main lab stainless steel, multiple overhead mixers are used to blend our eliquid thoroughly, second room is used for assembly of pipettes and caps as well as storage of product components - assembly is carried out on stainless steel table as well. Our juice is sent for bottling and is bottled by Zeftech whom utilize a positive pressure clean room for filling as well. Products are then returned to us for distribution to our lovely vendors.

Ratings/Certification - We intend to have an ISO test of our clean rooms air quality with an external company and will be happy to post our results soon. NCV follows the Class 1000 cleaning program.

Happy vaping!

Thank you @Vapington. So just to confirm, no bath tubs involved? We really need to fully and finally dispel that myth!

 

[Vapington]

Thank you @Vapington. So just to confirm, no bath tubs involved? We really need to fully and finally dispel that myth!

Haha definitely no bathtubs involved

 

[RichJB]

Great info, thanks @Vapington. As I see it, there are three possible areas where regulatory compulsory specs could be applied:

1) The juice itself. This would be regulated by a national standard that would prescribe that a juice must contain VG/PG/nic of a specified purity level, that the juice must contain less than x% of DAAP/heavy metals/whatever, etc. That would be dependent on ISO coming up with a juice standard and SA then adopting that as a SANS. I can't think of any compelling reason why SA would require an amended standard.

2) The production facility. Clean room standards, ISO good lab practice, etc. Those standards are already in place.

3) A broader QMS such as ISO 9001 or ISO 22000, which would probably include chain of custody so that components like nic or VG/PG batches could be traced to source.

I'm not sure which of those would eventually be implemented, I think number 3 is the least likely of the three as QMS are usually voluntary. But my sense is that juice will be subject to compulsory specs and thus placed under the auspices of the National Regulator for Compulsory Specifications (NRCS) which resides under the dti.

 

[RichJB]

It seems ISO are progressing quite well in the development of standards:

ISO/CD 20714 [Under development]
E-liquid -- Determination of nicotine, propylene glycol and glycerol in liquids used in electronic nicotine delivery devices -- Gas chromatographic method
ISO/DIS 20768 [Under development]
Vapour products -- Routine analytical vaping machine -- Definitions and standard conditions

Strange that they don't seem to include flavourings in the juice standard. Perhaps there will be a separate standard for that.

 

[Silver]

Great topic. There are a few things that need to be cleared up. Everyone is going on about ISO ratings and what not, but what does it actually mean? Here are our findings:

What is a clean room?

A cleanroom is any controlled environment in which the concentration of airborne particles is controlled to specified limits.

In simple terms:
Classing of clean rooms:

Cleanrooms are classed on two scales.

1. ISO 1 -9 (1 being the best and 9 being room air.)

2. FED STD 209E – ( Class 1 – room air) ( ISO 1 & 2 are not rated on this scale)

These levels are determined by the number of airborne particles present in 1m³ of air of a certain size. The table below is the standard for ISO rating
View attachment 101694

What this actually means.

To explain this we must look at one ISO rating (ISO 7 for example). If your room is rated ISO 7 it means that there are 352 000 partials per 1m³ of air at 0.5 microns, 83 200 particles per 1m³ at 1 micron and 2 930 particles per 1m³ at 5 microns (the thickness of a human hair ranges between 17 – 181 microns). As you move up the rating those number decrease as indicated in the above table.

FED STD 209E:

This rating system is very similar to the ISO system in terms of the particle size and numbers. The major difference in this system has to do with the cleaning requirements of the room. The following web site has the info for the cleaning requirements for Class 100 and Class 1000: http://www.coastwidelabs.com/Technical Articles/Cleaning the Cleanroom.htm


NCVs clean room:

At NCV our lab has the following specs:

Structure - Our lab is constructed from interlocking polyurethane (60mm thick) panels with a pre-paint chromadex skin, roof and walls all sealed up nicely. With large double glazed glass panels on the front.

Filtration - we use a positive pressure clean room to manufacture our products. This simply means that we keep our room at a constant pressure of 1.5 atmospheres keeping the contaminants out. Our air passes through 3 different filters before being blown into the room. Air passes through two UV Germicidal Lamps to kill off pathogens from the outside air. Air moves into our primary HEPA filter to trap larger particles, lastly the air moves though an F7 Synthetic Pocket Filter.

Equipment - Tables are stainless steel, shelving in main lab stainless steel, multiple overhead mixers are used to blend our eliquid thoroughly, second room is used for assembly of pipettes and caps as well as storage of product components - assembly is carried out on stainless steel table as well. Our juice is sent for bottling and is bottled by Zeftech whom utilize a positive pressure clean room for filling as well. Products are then returned to us for distribution to our lovely vendors.

Ratings/Certification - We intend to have an ISO test of our clean rooms air quality with an external company and will be happy to post our results soon. NCV follows the Class 1000 cleaning program.

Happy vaping!

That was an awesome and informative post @Vapington - thanks!

So you mean that there is almost zero chance of finding strange particles in your juice Other than the flavour, of course

We just need to see a photo of you in the positive pressure room - in a lab coat

 

[Vapington]

That was an awesome and informative post @Vapington - thanks!

So you mean that there is almost zero chance of finding strange particles in your juice Other than the flavour, of course

We just need to see a photo of you in the positive pressure room - in a lab coat

Haha well all these measures are taken to prevent that yes! Pics will follow soon once we get a chance!

 

[Cruzz_33]

Here are some GCC certificates of some of the E-liquids we carry. I will be trying to make contact with the Labs mentioned in these images and labs involved with other juices we carry and try get all their documents.

 

[craigb]

Here are some GCC certificates of some of the E-liquids we carry. I will be trying to make contact with the Labs mentioned in these images and labs involved with other juices we carry and try get all their documents.
View attachment 101746View attachment 101747 View attachment 101748 View attachment 101749
View attachment 101751

@Cruzz_33 you are a legend.

 

[Mauritz]

Hi Guys,

We are collecting the documentation for our current certification and will post it here ASAP. Thank you to @Vapington and @RichJB for covering all the finer details. Their information pretty much covers the spectrum on the question. The only colour I could add is why the standards exist and what certification means.

For the sake of conversation the below refers to manufacturing laboratories

The SANAS, ISO, SABS, and SANS body certifications means that the accredited party understands how to create an outcome in a repeatable manner as to assure the quality and consistency of the resulting product/test/process. In order to demonstrate this understanding and capability the organization prepares a series of standard operating procedures (SOPs) that detail the processes used in the manufacture of the product as well as how the organization conducts business. More broadly speaking the standards outline a requirement to define the people, process and technology required in order to meet the specifications laid out in a given standard.A organization is accredited after an audit of their SOP's and proof by demonstrating adherence to these SOP's.

In an effort to meet these standards TVM has set out on a 18 month road map to obtain various certifications we may require. Broken down below.

The people,

Our staff hold education and certification to assure that they understand how to operate within the standards we adhere to.

The process,

We currently operate under SANAS 17025. The details of this standard and its requirements can be viewed here for those with a few hours to kill. https://www.a2la.org/requirements/req17025.pdf. While this particular certification is aimed at the analysis side of our business. It does outline industry standard SOP's that we have conformed to for the rest of our processes.

We plan to obtain ISO 9001 phase 1 acceptance within the next few months and hope receive accreditation around February 2018. We may also pursue ISO 22716 as it closely aligns to what we expect to come from the ISO body in terms of regulation of this industry. When some derivative of the ISO 9001 standard for eliquid products becomes available we should be in a good place to conform to any specific requirements in addition to that which is already in place.

In the longer term we hope to apply for a license from the SAPC. This will make us a manufacturing pharmacy which will then enable us to import and process schedule 2 pharmaceuticals such as nicotine.


The technology

There are also SOP's for the management of controls in the environment ( such as the clean room ). These detail how these controls are managed, maintained and operated in order to ensure that they provide the outcome they are deployed to provide. These basically read as "The What, The How and The How to measure".

As recently as last week we underwent an audit of our clean room air quality and expect to receive our ISO 7 certification documentation next week.

With this all said and done, what it means for the consumer is that an organization has submitted their process for the manufacture of a product to the relevant accreditation body and that the body agrees that the organization meets the required standards to provide a safe and consistent product to their clients.

By providing auditable chain of custody that concludes with a certificate of analysis for each batch manufactured, we can provide assurance of the quality of a product from raw materials through to finished product. This allows us to identify a problem in the process or materials and make improvements where appropriate. We have published examples of the final Certificate of analysis in our sub forum for those that want to see what this looks like.


Regards,

 

[Silver]

Very interesting
Thanks for sharing the info and congrats on all the efforts @Mauritz

 

[zandernwn]

CURRENT STATE OF E-LIQUID MANUFACTURING STANDARDS
There is currently no prescribed requirement that addresses the clean room requirements for e-liquid manufacturing. A Lot of uncertainty exists around the official standards due a lack of regulation. It is up to e-liquid manufacturers and vendors to be the custodians of the quality of the products available in the market.

SUITABLE STANDARDS
There are multitudes of standards that are suitable to for the manufacturing of e-liquids. Unfortunately, it is up to each manufacturer to interrogate and determine which standard they deem acceptable. These include:

OFFICIAL PUBLISHED STANDARDS

• ISO 14644-1 and ISO 14698
• 5.2US FED STD 209E
• 5.3EU GMP classification
• 5.4BS 5295

I believe US FED STD 209E is discontinued but it is I still widely used and accepted as a legitimate standard.

INDUSTRY-LED PUBLISHED STANDARDS

There are a number of industry-led published standards such as E-liquids manufacturing standards published by Aemsa.org.

ADDRESSING CLASS ISO1-7 CERTIFICATION
To clarify further, the Class ISO 1-9 classification is merely a subcategory of ISO Unit Standards ISO 14644-1 and ISO 14698 and addresses specifically the air quality requirement, the unit standard as a whole address the clean room operations holistically i.e. people, processes, equipment, air quality and controls. The goal for manufacturers are to achieve certification on the unit standard as a whole - this way we have peace of mind that the production environment is controlled throughout the production life-cycle.

XHYPE LIQUID FACILITIES
Our clean room facilities are certified and meet requirements set out for a class ISO-8 certification for ISO standard ISO 14644-1 and ISO 14698 – we are in constant contact with the various certification bodies every step of the way to ensure each new addition/upgrade/improvement is aligned with the required standard.

Xhype Liquid Co. have invested in equipment that meet the class IS0-8 certification, even then the reality is that we will likely only achieve a class ISO-8 certification. The reason simply is that your clean room certification is dependent on the certification of the raw materials you use during the production process. Not all flavor manufacturers and PG/VG suppliers maintain that standard so achieving Class ISO-7 and higher will be challenging. So it doesn't matter what we do do from our side, the dependency greatly rests on the classification of the raw materials.

As an added note, we already source the highest quality raw products we can get our hands on.

WHY DID WE CHOOSE ISO 14644-1 and ISO 14698

Standards ISO 14644-1 and ISO 14698 speaks to the general requirements for a clean room environment.

ISO14644-1 addresses, among other things:

• Air Cleanliness
• Testing and monitoring for continued compliance
• Design and construction of the facility
• AND MOST IMPORTANTLY: OPERATIONS

Whereas ISO 14698 speaks to:

• The control of bio-contamination, contaminants introduced by lab staff.

Both aspect we deem incredibly important.

XHYPE LIQUID CLEANROOM SPECIFICATIONS

DESIGN

• Non-porous painted surfaces
• Non-porous, non-slip flooring
• Customized lighting

Air Filtration

• UV-Filters HEPA positive pressure air purification system that can service double our existing clean room foot print
• Runs 24-7
• Double glazed glass paneling and access-controlled door

Equipment

• Stainless steel working surfaces
• Stainless steel storage space
• Only lab certified equipment
• Only lab certified glassware

Hygiene

All the certification in the world means nothing if dirty booger hooks gets near the product during production!!!

• Strict staff hygiene protocols
• Lab is sterilized from top to bottom before and after mixing
• Appropriate apparel from the moment the product is mixed up to when it is finally sealed

Operations and Controls
We have and are implementing a host of processes that ensure our continual compliance to the standards.

We do this not because we have to but because of our vision of excellence and because we take pride the product we place on the shelves.