The glass reactor pictured below (figure 2), has a water bath, pressure and temperature-controlled devices is used to make ElaSkin Liquid Bandage. The reactor is made of corrosion resistant borosilicate glass which creates a vacuum or high pressure stability over a wide range of temperature, enabling us to run production with a high operational reliability. A consistent environment is extremely important in producing high quality products, it allows our Lead Manufacturing Scientist, Jia Luo, to control every detail and ensure quality control and consistency among ElaSkin's Liquid Bandage. This reactor can process anywhere from 1,250 to 2,500 units of ElaSkin Liquid Bandage at a time and the reactor is capable of making over 10,000 units each week.
Figure 2, our glass reactor
One critical parameter for a successful production run is the moisture level. The instrument shown in figure 3 is the Karl Fischer Coulometric Titration, which enables us to determine the water content of ingredients at a ppm level. We removed even trace amounts of water from the raw materials and maintained an inertial atmosphere for production. Every step of the manufacturing process is well strictly controlled including the raw material quality. We implemented the cGMP (current Good Manufacturing Practice) compliant quality system to ensure the high quality of each batch of products
Figure 3, Karl Fischer Coulometric Titration
ElaSkin is based on the patent-pending biopolymer technology invented by the R&D team in Aleo BME. It received the FDA 510(k) clearance for both over-the-counter and prescription uses to treat diverse minor wound conditions.
Luo, who has a background in Bio-Material Science and Analytical Chemistry, has been working at Aleo BME for over two years. He is currently the lead of the manufacturing team and says “I do love making this product. I believe that ElaSkin liquid bandage is the best liquid bandage… I believe our products really help a lot of customers… Every time when I read the customers' feedback about our product, I was really happy, and all of our efforts are worth it.”\
Packages ready to be shipped and used by customers.
This blog was originally posted on elaskinusa.com. To see it there, click here.
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