SMOORE, a global leader in offering vaping technology solutions, today announced the establishment of the world’s first extractable and leachable (E&L) testing laboratory in the vaping industry.
Built in the last half of 2021, this laboratory conducts qualitative and quantitative analytical testing and health risk assessment of E&L substances of electronic atomization components, including metals, plastics and other polymers.
As China’s first electronic atomization company to develop a PMTA (Premarket Tobacco Product Applications)-compliant assessment system, including physical tests, chemical tests, non-clinical testing and health risk assessment, SMOORE also set up this E&L testing laboratory based on PMTA safety requirements.
Moreover, SMOORE's E&L testing laboratory is in collaboration with SMITHERS, a world-leading provider of testing, consulting, information, and compliance services. For years, the two companies have worked closely on PMTA compliance.
Currently, most companies in the vaping industry rely on third-party laboratories for E&L testing while SMOORE has set up an in-house laboratory with comprehensive and advanced testing equipment. It follows the analytical methodology of the world’s leading E&L testing laboratories for medical devices.
As SMOORE’s flagship atomization tech brand, FEELM is able to make full use of SMOORE’s world-class testing and risk assessment system, including this E&L testing laboratory. Since 2021, FEELM has leveraged the laboratory for the safety assessment of its electronic atomization components, to guarantee the quality and reliability of FEELM's new products.
In October 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK has planned to integrate medicinally licensed e-cigarettes into the National Health Service (NHS). Other countries, including Australia, have also prescribed adult smokers e-cigarettes to reduce smoking rates. As global regulators started embracing e-cigarettes, they are setting higher safety requirements for e-cigarettes, and SMOORE takes the lead to improve the material reliability of e-cigarettes to medical grade.
E&L analytical testing is widely used in the field of pharmaceutical research and development. The E&L compounds of the packaging materials of pharmaceutical products must be tested before launch, to ensure the product safety compliance.
SMOORE's E&L testing laboratory can provide safety assessment for not only e-cigarettes but also electronic atomization products in other sectors. With one of its R&D focus on the application of atomization technology in healthcare and pharmaceutical fields, SMOORE could leverage this laboratory for the development of healthcare atomization innovations.
"The safety of electronic atomization products primarily depends on the chemical composition of e-liquid and the vapor generated by e-liquid atomization, as well as the E&L substances of other materials in contact with human bodies", said Dr. Long, Director of Analytical Testing and Safety Assessment of SMOORE Fundamental Research Center. "Our E&L testing laboratory specializes in the latter."
According to Dr. Long, SMOORE Fundamental Research Center plans to establish and complete a database of E&L substances in electronic atomization components, and will adopt the principle of Good Laboratory Practice (GLP) to ensure the quality and integrity of test data related to non-clinical safety studies. Meanwhile, SMOORE Fundamental Research Center is also looking for partnership with more Chinese medical device providers on E&L testing.
Since 2020, SMOORE has established its own safety standards, SMOORE 3.0, in accordance with the risk assessment guidance of U.S. EPA (Environmental Protection Agency). Above the safety requirements of the Tobacco Products Directive (TPD) of the EU and AFNOR of France, SMOORE 3.0 covers all of the PMTA tests, including both material safety and vapor safety.