| 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 |
|
