Automating Endotoxin Testing in a GMP Environment

Katharina Stoib

doi:10.5731/pdajpst.2026.26139

January 1, 2026PDA Journal of Pharmaceutical Science and Technology

Automating Endotoxin Testing in a GMP Environment

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Key Points

The aim is to improve endotoxin testing processes in a Good Manufacturing Practice (GMP) environment.
Implemented an automated endotoxin testing system.
Focused on reducing ergonomic risks and improving data flow.
Conducted routine testing to assess effectiveness and efficiency.
Increased data integrity was achieved during testing.
Reduction in time and resources required for endotoxin testing.
Simplified training requirements for personnel.

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Abstract

Roche has implemented an automated endotoxin system (Lonza PyroTec® PRO) in commercial Quality Control microbiology.The key drivers for the implementation were to reduce ergonomic risk, save time and resources, increase data integrity, simplify training, digitalization, digital data flow and increase the right-first-time rate.The strategic approach to implementation and conclusions from routine testing shall be shared and discussed.

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Katharina Stoib (2026) studied this question.

synapsesocial.com/papers/69a67e0ef353c071a6f09f1d https://doi.org/10.5731/pdajpst.2026.26139

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Automating Endotoxin Testing in a GMP Environment

Key Points

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Automating Endotoxin Testing in a GMP Environment

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