What question did this study set out to answer?

The aim is to evaluate the effectiveness of sporicidal disinfectants in aseptic manufacturing and assess risks linked to performance failures.

March 3, 2026

Aseptic Process Challenges: The Threat of Underperforming Disinfectants for cGMP Applications

Key Points

The aim is to evaluate the effectiveness of sporicidal disinfectants in aseptic manufacturing and assess risks linked to performance failures.
Evaluated disinfectant efficacy using the Disinfectant Efficacy Test (DET).
Analyzed various sporicidal solutions in line with USP <1072> standards.
Conducted assessments over three timeframes, including CAPAs after sterility failures.
Reviewed impacts of supply constraints on disinfectant availability.
Identified risks tied to disinfectants that fail to meet performance standards.
Highlighted challenges from resistant microorganisms, despite their low isolation frequency.
Emphasized implications for commercial operations due to inadequate disinfectant performance.

Abstract

This poster evaluates the Disinfectant Efficacy Test (DET) of various sporicidal solutions and chemistries used in an aseptic manufacturing site for parenteral and ophthalmic products, guided by USP . The assessment spans three different timeframes: the initial DET evaluation and two Corrective and Preventive Actions (CAPAs) prompted by sterility failures years later. It includes an analysis of different bacterial spore formers and the impact of disinfectant supply constraints on the market.The poster discusses the risks associated with the use of disinfectants that do not meet performance standards, emphasizing their potential threat to commercial operations. Additionally, it addresses the challenge posed by microorganisms with higher natural resistance, even when their isolation frequency is low in the environmental monitoring (EM) program.

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Aseptic Process Challenges: The Threat of Underperforming Disinfectants for cGMP Applications

Key Points

Abstract

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