As I am writing this it is May 21st, 2020. We are 2 months into full-blown COVID-19 shutdown. And Haiku Instruments is still moving towards our product launch target date of July 1, 2020.
The first alpha system's enclosure will be out of the fabrication shop next week. Once that is finished, we can get all the sub-systems installed, begin wiring up power and communications, and run diagnostics on each component via the software's maintenance tab.
What do we already know works based on individual component testing? Solvent pump? Check.
Both Syringe Pumps and Valves? Check. Injection Valve? Check
Backflush Valve? Check.
Digital Pressure Transducers? Check
Purge Solenoid Valves? Check
What's left for hardware?
Oven heater PID controller tuning
Autosampler motion & feedback
Analytical Balance communication
What else are we working on in the software? Automation and smart data processing.
One-button routines for a daily or per-shift "fit for use" check on all hardware components.
Methods designed for "loaded" samples to back-flush after each N injections Algorithm to ensure a random bubble does not impact calculations
Algorithm to validate data quality "on-the-fly" and notify of suggested maintenance steps
Algorithm to track baseline trending and flag potential problem samples
For you service specialists out there: we thought of you, too!
Predictive maintenance service counters to track usage of all moving parts:
Purge Solenoid Valves
Syringe barrel and valve cycles
With the database-structure, defined access levels for admin, managers, technicians and service personnel... 21 CFR part 11 compliance is nearly wrapped up. Now it's just a matter of building out datasets and trying our best to break the software in all ways possible before it goes out the door. More on that once the hardware is set up and we are running samples.