IQ/OQ/PQ of Depyrogenation Oven and Autoclave

Client Type

503B outsourcing facility preparing to manufacture sterile drug products using terminal sterilization and dry heat depyrogenation

The Challenge

The client had recently installed a depyrogenation tunnel and a large-capacity steam autoclave. Both were critical to the sterile product manufacturing process, and both required full IQ/OQ/PQ to meet FDA and CGMP expectations.

Our Solution

Restore Health Consulting delivered full lifecycle validation support:

  • Developed IQ/OQ protocols based on manufacturer specs and USP <1224>/<1211> expectations

  • Performed thermometric and biological indicator testing for PQ

  • Created custom load configurations to simulate worst-case scenarios

  • Summarized all data in traceable, audit-ready reports

The Outcome

✔ Equipment was fully qualified and placed into GMP use
✔ Load configurations were validated for worst-case penetration and heat distribution
✔ Protocols and reports were used directly during FDA inspection

“Restore’s validation work gave us confidence when walking FDA through our sterilization process.”