E-cigarettes are not classified as medicinal products or as medical devices (definition can be found in the Appendix). As such, are not required to adhere to these medicinal product manufacturing guidelines, however a practical set of Guidelines are required to support the Manufacture of our Products.
In the case of Firefly II and Innokin specifically, there is no handling or filling of any substances (including formulation) at the facility.
The approach is not to implement the clean room grade requirements (namely the airborne particulate and additional microbiological monitoring). However, best practices will be employed to ensure that the facilities and manufacturing conditions are fit for purpose and ensure that personal protection equipment (PPE) is employed where required.
The proposed manufacturing facilities for the Firefly II product are based on the requirement of the component being assembled. These are different for the clearomiser and the battery due to the differences in the intended consumer use and consumer interaction.