So as
@AmandaD,
@UncleRJ, and
@MrFixIt alluded to, there is a difference between a "clean" room, a "cleanroom" and a "sterile" room.
I doubt that there is a single vendor in the country, and possibly the world, (including
@Smoky Blue) mixing their eliquid in a "cleanroom". A "cleanroom" is an environment with a highly controlled amount of any contaminants measured in parts per cubic meter, including dust particles. There are different certification levels for "cleanrroms" defined by several ISO and Federal standards. "Cleanrooms" are mainly used in manufacturing facilities making microprocessors because a single dust mote in the manufacturing process can run a chip.
From past work experience, "Cleanrooms" commonly cost more than $50,000 to set up because of cost of the air filtration and entrance/exit equipment in addition to the materials for the ceilings, walls, and floors which is far higher than any of the furniture, tables, and equipement that would be required to make e-liquids.
A "sterile" room is similar to a "cleanroom" but nowhere near the standards. US operating rooms are not even sterile rooms, they have "sterile fields" which apply to a sphere of area immediately surrounding the operating table. In every major operating room there is a Surgical Nurse who manages everything that transfers between the sterile field and the surrounding room like additional surgical implements and supplies, but they themselves are not held to the same level of sterile cleanliness that the operating team is.
A "clean" room is just that, a room that is clean. Most labs are simply clean, not "cleanrooms" as defined by ISO and Federal standards.
AEMSA standards are defined in Article III of the "E-Liquids Manufacturing Standards 2014 Version 2.0" as:
Section 3.02 ...........Manufacturing Environment
- (a) Manufacturing processes will meet food preparation standards to include
- (i) Non-porous sanitized preparation work surface
- (b) All surfaces in lab/mixing area (floors, counters, etc.) shall be cleaned with anti-bacterial agents at least once each day and after any spill of any mixing ingredient or any possible-contaminants
- (c) Equipment will be cleaned by FDA Approved Chemical Sanitation or autoclave
- (d) All supplies and material will be disposed of in a manner that is appropriate to component disposal - proper disposal of production material
- (e) There shall be no open fans, dusty boxes and/or other potential sources of airborne contaminants etc. in dedicated space
- (f) All bottles and materials unpacked outside of dedicated lab/mixing space
While it is unfortuante that this vendor's after hours use of their mixing room was posted and will have a short term impact to their reputation because of people's reactions, their stated standards of preparing that room prior to mixing is most likely as good as, if not better than most makers of e-liquid.
And as far as China is concerned... the mixing rooms of the major players are most likely cleaner than most mixing rooms used by US companies. My personal concerns about Chinese liquids is the all to frequent occurances of Chinese companies using ingredients and components of products that do not meet US food and product safety regulations.
