Page 230 - Biomedical Engineering and Design Handbook Volume 2, Applications
P. 230
STERILE MEDICAL DEVICE PACKAGE DEVELOPMENT 209
Operational Qualification (OQ)
Investigate optimum Visual inspection
process parameters
Pkgs meet
NO visual quality
YES
Packages produced @
optimum parameters
Visual inspection
Pkgs meet
visual quality
NO
YES
Leak Tests
Pkg integrity
FAIL
PASS
Production packages
Burst tests Seal strength tests
RESULTS RESULTS
Establish Pkg GO TO
performance PHASE 2
specifications
FIGURE 7.2 Operational qualification flowchart example.
