What modifications of devices and facilities will be necessary for 152a?
With device components, we know that the valve manufacturers and the can manufacturers and the actuator manufacturers have all got products they believe are ready for 152a, and it’s not a substantial change in any way, shape, or form from what they have for 134a and 227.
In terms of the basic filling equipment, 152a is compatible with the same materials of construction as current equipment, so a 152a filling line would have exactly the same components as a 134a filling line. Although 152a is somewhat flammable, the equipment used for 152a is the same as for 134a because high containment is required even for 134a systems.
Where you do have to be careful is in the MDI filling facility itself; you end up having to put in extra protections such as gas detection; and you may need to modify systems such as leak management and heating and ventilation. Koura have developed a basic questionnaire to help customers determine what they would need to do, and we can advise on solutions for quite a lot of the problems people might encounter. If you build a brand new facility, fundamentally the costs between a 152a facility and a 134a facility is the same.
Does the flammability of 152a present other problems?
What we should remember is that many formulations out there today are 134a with ethanol; and once you put ethanol into a 134a mixture, it is flammable as well. So flammable mixtures are not new to the industry; it’s just that 152a has different flammable characteristics to a 134a/ethanol mixture.
If you go to North America, 152a is used in most personal care products with a non-metered valve and a 100 g or 200 g charge of propellant in there, so it’s available to use. In terms of the device, there’s no change in risk to the consumer, and in an MDI, there’s no change in risk to the patient.
What is the anticipated timing of the transition?
Some companies will get to the market more quickly than others; some have already announced products that will come to market in 2025 at full commercial scale, which means that the sponsors need to have a defined formulation and appropriate data for a regulatory submission in 2021 or 2022. One challenge with timing is that some of those products will get there ahead of the environmental regulation timeline; some will get there around the same time as the environmental regulations.
As certain companies have announced that they are investing billions of dollars in new, more sustainable facilities, including 152a production facilities, the environmental regulators are saying, maybe now is the time to evaluate how we should change the environmental regulations to encourage anyone who isn’t moving already to start thinking about adopting and coming up with a timeline of their own.
If products start coming to market in 2025, there’s no real reason why the environmental regulator won’t regulate at that point. And we would expect therefore the regulation to start to bite in the period 2025-2030.
How can companies get started on the transition if they haven’t already?
Koura can help because we have already done a lot of the feasibility work; it just needs to be translated to a specific site or business or particular formulation. If companies want to do their own feasibility work, we can make samples of 152a available today so they can quickly move to handling 152a in their own laboratories. If they don’t think they can do that, there are companies out there, including Koura, that can do that for them and give them the data.
