Cerulean’s new vaping machine allows for regulatory and cell exposure studies of next-generation products.
By Stefanie Rossel
The rise of next-generation tobacco products has brought about new requirements for testing equipment to assess the emissions of these products and their impact on the human body. The most recent launch by Cerulean, a British manufacturer of precision test and measuring equipment, has been designed precisely for this. Named Chimera, the new vaping machine is a flexible and versatile test station for the comprehensive study—on-line and off-line—of the effects of aerosol vapors on primary cultures and cell lines.
According to Cerulean, the Chimera is the first dedicated vaping machine to produce a near-continuous vapor phase for use with exposure studies. The continuous vapor created by the 30-port vaping machine replicates the vapor generated throughout the entire life of an e-cigarette or heat-not-burn (HnB) product, from the first puff to the last puff.
“Continuous vapor production is essential when exposing in vitro cell cultures to a steady and consistent vapor stream, sometimes for many hours at a time,” explains John Campbell, marketing manager at Cerulean. “The Chimera enables this with the added sophistication of delaying the start of specified heads of e-cigarette vaping, so creating a vapor stream that is representative of the whole lifetime of the e-cigarette—a sort of ‘average’ in terms of composition and physical form.”
The machine can be configured to produce continuous vapor for any stage of the e-cigarette life, the company claims, thus enabling, for instance, a comparison of the exposure effects of the first 50 puffs with the last 50 puffs to better understand the influence of coil annealing, e-liquid delivery and vapor generation performance on biological systems. The Chimera features a fully traceable software data system that has been prepared and audited for use in a 21 CFR Part 11 environment. “This should assist when submitting results for third-party validation,” says Campbell.
Focus on toxicological effect
In the development of the machine, particular attention has been paid to the pathways. The design is centered on preserving the integrity of the vapor both chemically and as a physical aerosol, according to Campbell. “Designed with consistent heated pathways, the Chimera allows minimal changes to particle size within the machine, allowing more accurate exposure,” he says. “This is a move from chemical analysis to studying the toxicological impact of e-cigarette vapor, a key to understanding where e-cigarettes can be placed on a harm continuum.”
The heated pathways ensure that the vapor interacts with cell cultures at blood temperature and also significantly reduce the vapor loss due to condensation buildup within the machine. “This is coupled with very short pathways that are chemically inert, which preserves the physical and chemical composition of the vapor so that the vapor exiting the Chimera is the same as the vapor exiting the e-cigarette,” says Campbell.
The Chimera has the added functionality for the capture of vapor aerosols using traditional 44 mm Cambridge filter pads. “2018 will bring additional functionality, including use with electrostatic capture, 92 mm filter pad capture and button activation,” says Campbell. “All these add to the Chimera functionality, so it can be used for both toxicology studies and more traditional off-line capture for chemical analysis, which effectively makes it two machines in one.”
Other features of the vaping machine include the ability to carry out angled vaping over 180 degrees in order to mimic how people hold vapor products. A temperature control reduces premature aerosol condensation—the vapor of e-cigarettes and HnB products is very wet. A user-defined regime allows the Chimera to be configured for any duration of experiment along with puff volume, shape, puff duration, puff interval, temperature, angle, puff count per piece and total puffs required. In addition, it has an optional delayed start for “whole vapor life” generation. A software system guides users to design experiments that can utilize the full capability of the machine. According to Cerulean, users also benefit from the high throughput for pieces and the ability to run continuously for many hours.
The Chimera’s approach to combine the vapor streams from each individual e-cigarette into a single exit stream that is intended to be used to expose cell cultures for toxicology testing is a move away from Cerulean’s traditional focus on chemical analysis of smokes and vapors. “The Chimera does not look like a smoking machine. It is something quite different, and it has been designed for the e-cigarette market,” says Campbell. “We started from trying to make the most flexible and appropriate machine for e-cigarette toxicology studies and believe we have achieved this by drawing on our experience of the conventional burn-down world but not being constrained by this experience.”
Since the introduction of the machine in September 2017, he says, the company has had significant interest from customers around the globe. “Our production has been running at full capacity to meet the initial demand, and we are excited to continue this into 2018.”
Two in one
