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