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March 3, 2026PDA Journal of Pharmaceutical Science and Technology

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

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Authors

OCOmar Cruz

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Overview

Poster evaluates disinfectant efficacy for aseptic manufacturing, suggesting risks of underperforming solutions.

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.

Cite This Study

Omar Cruz (2026) studied this question.

synapsesocial.com/papers/69a67e0ef353c071a6f09f79https://doi.org/10.5731/pdajpst.2026.26110
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Standardization of an Effective Disinfection Methodology Against Microorganisms Isolated from a Pharmaceutical Industry Facility as a Contamination Control Strategy2026
  2. 2Development, Validation, and Implementation of a Pharmaceutical Facility Disinfection Program.2026
  3. 3Cleanroom Disinfectant Qualification (DET) as Part of Your Contamination Control Strategy and Other Annex 1 Considerations: To Wipe or Not to Wipe2026
  4. 4Does Disinfection Influence your Environmental Monitoring Data or Does your Environmental Monitoring Data Influence your Disinfection Protocols?2026
  5. 5In-situ Verification of Disinfection Rotation for Contamination Control2026