George,
I really don't believe that there is a limit as to how many EDEN units can be built, if there is a demand, suppliers who can mass produce it will be found. St. Gobain's Glass should certainly be able to deliver all the disposable cassettes as are needed.
Certainly, it's possible that short term shortages of key components may cause short term delays, but if the demand is there the supply will expand to meet it over time.
What's unclear, until the company gives us firm information, is just how many batches a year each EDEN unit can produce. Some people believe it can cut the time required to manually make the vaccine substantially, perhaps to just 5 days or so, worst case it takes as long as manually, i.e. about 8 days. This would make worst case about 45 batches per year, best case over 70 batches a year per EDEN unit. I don't believe each unit uses that much energy, or produces that much heat, so numerous units should be able to operate in a substantially sized cleanroom with little staff support, mainly to load and unload the EDEN unit with each new batch. The machine itself never touches the vaccine, so I don't believe substantial work is required on the machine between batches of vaccine. The pumps, that are key to the units, are like the pumps used to control IV flow in hospitals, they use the tubing that's part of the disposable cassette, so at no time is the fluid in contact with any part of the EDEN unit itself.
Gary
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