Validation of Moist Heat Sterilization Processes
The PDA Technical Report N.1 “Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control” presents on pages 4-7 a complete list. We are reporting the title of each definition.
Air Detector |
F-Value (Lethality Factor) |
Penetration Probe |
Survivor Curve |
Air Overpressure Sterilization Process |
Fraction-Negative Methods |
Physical Qualification |
System Suitability Evaluations |
Air Removal Test |
Gravity Displacement Process |
Porus/Hard Goods Loads (P/HG) |
Temperature |
Biological Indicator Challenge System |
Half-Cycle Qualification |
Pre-vacuum Process |
Temperature Distribution |
Biological Qualification |
Heat |
Probability of a Non Sterile Unit (PNSU) |
Terminal Sterilization |
Bracketing Approach |
Heat Penetration |
Process Performance Qualification(PPQ) |
Validation |
Calibration |
Heat-Up Phase |
Product Specific Design Approach |
Worste Case Load |
Chamber |
Leak-Rate |
Pure Steam |
z-Value |
Chamber Cold Spot |
Liquid Load |
Resistometer |
|
Chamber Heat-Up Time |
Maximum Load |
Routine Operational Cycle |
|
Chemical Indicator |
Saturated Steam |
||
Chemical Integrator |
Minimum Load |
Steam-Air Mixture Process (SAM) |
|
Cool-Down Phase |
Minimum Acceptable Cycle (MAC) |
Sterilization |
|
Container Cold Spot |
Mixed Load |
Sterility Assurance Level (SAL) |
|
Dryness Value |
Moist Heat |
Sterilization Cycle |
|
D-Value |
Non condensable Gases |
Sterilization Run |
|
Equilibration Time |
Operating Parameters (Critical and key) |
Superheated Steam |
|
Exposure Phase |
Overkill Design Approach |
Superheated Water |
|
Parametric Release |
Superheated Water Process |