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Tuesday, July 12, 2022 10:06:44 AM
Including your previous posts
"ski, you’re right that the Flaskworks system uses single-use disposables, but GMP rules are very explicit, and every facility will have documented procedures for regularly scheduled cleaning, sanitizing, inspecting, and maintaining of each piece of equipment and all work areas. The cleaning procedures will detail the type of cleaning agent, the pH, the strength, contact time for sanitizing the surface, what agent to clean off the sanitizing agent, etc. Detailed records will be kept of all these activities which report, not only proof of what cleaning took place, but who, when, and the outcome."
The GMP rules also support automation withing manufacturing facility, and this is certain a major advantage for the latest Flaskworks devices. Since each Flaskworks device has the ability to directly connect with a main data base control network, the entire process (7-days) can be monitored and recorded in real time including all cleaning process. Multiple Flaskworks units will be the key factor to support the growing number of patients that I hope will have access to all of NWBO's manufacturing facilities as they continue to move forward.
Roman516
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