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
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 1-7 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 lifecycle.
XHYPE LIQUID FACILITIES
Our clean room facilities are not formally certified as yet, but meet requirements set out for a class ISO-3 certification for ISO standard ISO 14644-1 and ISO 14698 – we are in constant contact with the various certification bodies every step of hte way to ensure each new addition/upgrade/improvement is aligned with the required standard. We have made a decision to delay seeking certification because we are in the process of implementing production automations and installing further upgrades to our production facilities. It will be too costly to seek certification now and then end up having to re-certify the clean room in a month or two again. We aim to have the certification done before the end of the year.
Xhype Liquid Co. have invested in equipment that meet the class IS0-3 certification, even then the reality is that we will likely only achieve a class ISO-7 certification. The reason simply is that your clean room certification is dependant 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-3 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:
Both aspect we deem incredibly important.
- The control of bio-contamination, contaminants introduced by lab staff.
XHYPE LIQUID CLEANROOM SPECIFICATIONS
DESIGN
Air Filtration
- Non-porous painted surfaces
- Non-porous, non-slip flooring
- Customized lighting
- 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.
View attachment 102285
Now that's what I call "Doing things properly".
