Methods

1. Bioburden Method: Lethality Confirmation

• ? Direct Count/Enumeration Method
• ? Fraction-Negative Method

2. Overkill Method: Demonstrating ?12-Log Reduction

• ? Half-Cycle Method
• ? Cycle Development Method

Key Terms

• Bioburden
• 12-log reduction
• D-value

Methods Overview

1. Half-Cycle Method (Basic Principle – Run Count)

• Theoretical initial bioburden: 10?
• Test Criteria:
  • 1 run with survivors allowed (“partial cycle” or “short cycle”)
  • 3 half-cycles with zero survivors required

2. Cycle Calculation Method

• Requiresknown initial bioburden & lethality rate
• Method selection basis: SeeFraction-Negative Method

3. Direct Count Method

• Requiresknown initial bioburden
• Test Criteria:
  • 1 run without sterilant (control)
  • 1 run demonstrating ?4-log reduction
  • 3 runs with intermediate reduction levels

4. Fraction-Negative Method

• Requiresknown initial bioburden
• Statistical Models:
  • A3.2 HSKP (Holcomb-Spearman-Karber Procedure)
  • A3.3 SMCP (Proċedura Stumbo-Murphy-Cochran)

Tipi ta' Indikaturi Bijoloġiċi (BIs)

• Strixxa/Disk BI
  Strixxa/Disk BITrasportatur miksi bil-mikro-organiżmu (eż., karta/diska tal-filtru) li jeħtieġ trasferiment għal midja tat-tkabbir għall-inkubazzjoni.
• BI Ibbażat fuq Ampulla
  Ampulla tal-ħġieġ li fiha l-ispori u mezz separat tat-tkabbir (jeħtieġ tgħaffiġ manwali biex tattiva).
• 
  BI Self-Contained
  Unità integrata: Strixxa ta' spori + mezz ta' tkabbir f'kunjett wieħed (attivazzjoni bil-kompressjoni).

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