With the surge in popularity of electronic cigarettes, the need for regulation and standardization of e-cigarette and e-liquid manufacturing has emerged. In May 2016, the FDA issued a final rule which brought these products under its authority. In addition to regulatory compliance, cleanrooms for e-liquid manufacture allow for quality control and product consistency by providing a controlled environment free of harmful contamination.
The American E-liquid Manufacturing Association dictates a dedicated “lab/mixing space” and that manufacturing processes meet food preparation standards. (Click here to see the current AEMSA standards.) E-cigarette and e-liquid manufacturing is now regulated by the FDA, which is working to require that these products be manufactured within a controlled cleanroom environment. The necessary cleanroom classification is dependent upon the specific product and process, but e-liquid manufacturing would generally require cleanrooms to meet and be certified to ISO Class 7 or ISO Class 8 standards.
When it comes to installing a cleanroom for your e-liquid manufacturing business, sooner is better than later, especially with FDA legislation looming. Modular cleanrooms are one of the best options for e-liquid cleanrooms for a variety of reasons. Modular clean rooms have better lighting options than traditionally constructed spaces, as well as greater flexibility since modular cleanrooms can be easily reconfigured or expanded when your operation changes. They are often less expensive and time-consuming to install than traditional construction and offer greater flexibility when it comes to location and placement. Modular cleanrooms are essentially self-contained and can be placed nearly anywhere in your space for greatest efficiency and convenience, even in the middle of a large warehouse-type building.
Additionally, various parts of your process may require different levels of cleanroom control. Hardwall cleanrooms provide the highest level of control over contamination, humidity, and pressure, and are ideal for manufacturing activities and quality control testing; softwall cleanrooms can provide clean, contaminant-free space for e-liquid bulk storage.
As demand for e-liquid increases, so does consumer and regulatory scrutiny on its manufacture. Manufacturing e-liquids in a cleanroom environment is becoming a necessity, and ensuring that the cleanroom meets the industry ISO standard and your company’s needs is an important consideration.
Designing a cleanroom for your e-liquid company? Call Angstrom Technology. We have the experience and the technology to create the cleanroom you need.