Freeze dryer SCADA with 21 CFR Part 11

The brief

Lyophilization Systems Inc. of New York builds freeze dryers, through its Indian arm as well. Since about 2005 we have developed the control and monitoring software that ships inside them, built for 21 CFR Part 11.

What we built

Recipe control of freezing, primary and secondary drying with every parameter and action logged to Part 11.

• Recipe control

  The software runs the full recipe: freezing, primary drying and secondary drying. It controls shelf temperature, chamber pressure, condenser temperature and vacuum.

• Part 11 by design

  Every parameter and operator action is recorded to 21 CFR Part 11 on GE iFIX, with electronic signatures and audit trails.

• Exported worldwide

  The machines are exported to Southeast Asia, the Middle East, Europe, China and Russia. We commissioned two systems on site in the United States.

Outcomes