As the popularity of E-Cigarettes, personal vaporizer (PV), e-juice, e-cig or electronic nicotine delivery system increase so does the need to meet potential government regulations. It is anticipated that regulations will be in place within three years with an estimated two years to comply.
Up front thinking vape manufacturers of E-Cigarettes who believe that they will see FDA regulations imposed in the near future are seeking answers as to the best environment in which to manufacture their product that will meet these upcoming regulations. Some states, I.E. Utah, New Jersey, North Dakota have already set some guidelines on the manufacture of E Cigarettes and others are now working on regulating manufacturing environments.
In the absence of state and federal guidelines we are currently recommending that vape manufacturers model their critical environments, cleanrooms, after the USP 797 Pharma Codes, the purpose of which is the to prevent infections in patients using pharmaceutical products as well as to protect pharmacy staff members that are ordinarily exposed to these products.
These cleanrooms are designed as a recirculating air flow system where the largest percentage of the HEPA filtered air passes through the work zone to low wall returns and back to a plenum area, located above the drop ceiling, where it is mixed with conditioned filtered air to meet temperature and required humidity requirements and room pressurizations. Also available are “single pass airflow system” cleanrooms where ambient air is introduced into the cleanroom through fan powered HEPA filters and returned to ambient via low wall exhaust dampers.
We understand the need to accommodate large barrels of liquid nicotine and flavoring used in the vape manufacturing process while maintaining the overall cleanliness of the cleanroom. In addition we will recommend cleanroom furniture and consumables for each specific clean environment and vape manufacturing process and will establish complementary operator protocols and cleanroom maintenance guidelines.
The cleanroom is generally designed as a standalone structure but can also utilize existing walls. The cleanroom is generally divided into three specific areas:
The physical characteristics of construction: walls, floors, fixtures and ceilings should be smooth, impervious and free of cracks, crevices and be non-shedding. Surfaces should also be resistant to damage from sanitizing agents. Wall to wall and wall to ceiling junctures should be coved and / or caulked. Ceiling panels, light troffers and filter units should be caulked in place to eliminate any seam. Walls may be panels locked together and sealed, reference CZT I hardwall, Floors can be Epoxy or similar material coated or overlaid with sheet vinyl flooring with heat-sealed seams. Both systems should incorporate floor to sidewall coving to a minimum of 4”.
We also offer the CZT IV cleanroom. The CZT IV cleanroom design allows it to be used as a totally free standing room, or in a combination with your existing walls. The CZT IV is specifically designed to meet requirements of a wide range of industries including the medical, pharmaceutical, parts cleaning, electronic, disk drive. The CZT IV can be designed to meet ISO Class 5 (Class 100) through ISO Class 8 (Class 100,000) and can be divided into as many individual rooms as required. The cleanroom can be equipped with single or double doors, strip curtains and standard or custom sized Pass-Thru boxes. Each Aluminum CZT IV is completely factory prefabricated to minimize on-site installation time. All components are furnished. All you have to do is supply electricity and A/C. The CZT IV is demountable and can be easily relocated in another section of your site or another part of the country. Average installation time is 2 to 3 days from start to certification (depends on overall size).
If cleanliness is the only concern please look into our CZT III modular softwall cleanroom that is our most economical room design. The CZT III is designed to meet requirements of a wide range of industries including the parts cleaning, electronic, clean packaging to name a few. It is our experience that the CZT III will be moved from one product line to another as required. The softwall cleanroom is totally freestanding or it can be used in combination with your existing walls and ceiling. The room comes in varying heights to 16’+ and can be equipped with an internal or external Gowning Room. The modularity of the cleanroom is also enhanced with the addition of locking caster.
The FDA has been also been monitoring the medical marijuana industry and a number of states have approved its use. Progressive marijuana growers and processors are also looking to upgrade their facilities to meet expected FDA regulations. The proceeding guidelines are also recommended for this industry.
Marijuana Grow Houses
We are finding that a closed recirculation environment is beneficial to grow houses in the prevention of cross-pollination and the spread insects. An ideal solution is to build a modular structure that will meet the necessary containment and cleanliness requirements.
A huge plus, for all of the three mentioned industries, is selecting a modular enclosure. The fact that it is MODULAR is a great benefit to a growing business. They install in a very short period of time with minimal amount of contamination, are not a permanent part of the building and can be disassembled and relocated and expanded as required.
In the absence of state and federal guidelines we are currently recommending that both industries model their critical environments, cleanrooms, after the USP 797 Pharma Codes, the purpose of which is the to prevent infections in patients using pharmaceutical products as well as to protect pharmacy staff members that are ordinarily exposed to these products. The environments can be modified to minimize costs with the potential to upgrade if needed.
These cleanrooms are designed as a recirculating air flow system where the largest percentage of the HEPA filtered air passes through the work zone to low wall returns and back to a plenum area, located above the drop ceiling, where it is mixed with conditioned filtered air to meet temperature and any humidity requirements. In reviewing USP 797 you will note that the document deals heavily with the processing and compounding procedures and the safety of the technicians. Not to be minimized is the included facility requirements.
What is USP 797?
USP 797 is a far-reaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations are prepared, stored, and dispensed. The purpose of the regulation is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are ordinarily exposed to pharmaceutical products. Below is a summary of the USP 797 regulation.
Source of base information: Pharmacopeial Form - Volume 29 (4) July - August 2003
Effective Date: January 1, 2004
FDA enforceable: yes
A good reference source is: www.usp797.org
Please don’t hesitate contacting us firstname.lastname@example.org or at 719 684-7800 so we can work together to develop a cost effective environment that can meet your current needs and that can be upgraded to meet upcoming regulations.