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Related Experiment Video

Updated: Nov 16, 2025

Identification of Intracellular Signaling Events Induced in Viable Cells by Interaction with Neighboring Cells Undergoing Apoptotic Cell Death

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Wanted: Dead or Alive.

James P Agalloco¹

¹Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502 jagalloco@aol.com.

PDA Journal of Pharmaceutical Science and Technology

|February 20, 2021

Summary

This summary is machine-generated.

Sterilization validation in the US often assumes "overkill" based on absent microorganisms. This study proposes using a VDMAX-inspired strategy for accurate sterilization cycle efficacy determination and improved probability of a nonsterile unit (PNSU) assessment.

Keywords:

Bioburden Biological indicator Probability of a nonsterile unit (PNSU)Regulation Sterility assurance Sterilization Terminal sterilization

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Area of Science:

Microbiology
Sterilization Science
Medical Device Manufacturing

Background:

Current US sterilization validation heavily relies on demonstrating microorganism destruction to ensure lethality.
The concept of
overkill
is often targeted, assuming complete destruction of resistant spores supports a minimum probability of a nonsterile unit (PNSU).
Absence of recoverable microorganisms during validation hinders accurate PNSU determination.

Purpose of the Study:

To introduce a novel approach for sterilization cycle development and validation.
To demonstrate how a strategy inspired by ISO 11137-2, VDMAX, can accurately support sterilization cycle efficacy.
To encourage further research and refinement of this method based on practical experience.

Main Methods:

Adopting a strategy inspired by the VDMAX method from ISO 11137-2.
Utilizing positive results from this VDMAX-inspired approach for validation.
Focusing on accurate determination of sterilization cycle efficacy.

Main Results:

The proposed VDMAX-inspired strategy provides a robust method for supporting sterilization cycle efficacy.
This approach allows for more accurate assessment of the probability of a nonsterile unit (PNSU).
The absence of recoverable microorganisms is addressed by focusing on a defined lethality approach.

Conclusions:

The VDMAX-inspired strategy offers a potentially superior alternative to traditional "overkill" assumptions in sterilization validation.
Accurate PNSU determination is achievable through this refined validation approach.
This method holds promise for advancing sterilization cycle development and validation practices.