A biosafety toolbox for manufacturing with single-use systems

Richard Denk; Reinhold Maeck; Dirk Motzkus; Carola Dreier; Bernhard Steidle; Andreas Seiffert; Stefan Woog; Harald Eriksson; Charlotte Hieke; Chris Williams; Susanne Konrad; Joachim Regel; Sven Verguts

doi:10.5731/pdajpst.2025-000003.1

Research ArticleResearch Paper

A biosafety toolbox for manufacturing with single-use systems

Richard Denk, Reinhold Maeck, Dirk Motzkus, Carola Dreier, Bernhard Steidle, Andreas Seiffert, Stefan Woog, Harald Eriksson, Charlotte Hieke, Chris Williams, Susanne Konrad, Joachim Regel and Sven Verguts

PDA Journal of Pharmaceutical Science and Technology May 2025, pdajpst.2025-000003.1; DOI: https://doi.org/10.5731/pdajpst.2025-000003.1

Richard Denk

SKAN AG

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For correspondence: richard.denk@skan.ch

Reinhold Maeck

Boehringer Ingelheim

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For correspondence: reinhold.maeck@boehringer-ingelheim.com

Dirk Motzkus

Boehringer Ingelheim

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For correspondence: dirk.motzkus@boehringer-ingelheim.com

Carola Dreier

Boehringer Ingelheim

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For correspondence: carola.dreier@boehringer-ingelheim.com

Bernhard Steidle

Boehringer Ingelheim

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For correspondence: bernhard.steidle@boehringer-ingelheim.com

Andreas Seiffert

Boehringer Ingelheim

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For correspondence: andreas.seiffert@boehringer-ingelheim.com

Stefan Woog

Boehringer Ingelheim

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For correspondence: stefan.woog@boehringer-ingelheim.com

Harald Eriksson

Biolamina

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For correspondence: Harald.eriksson@biolamina.com

Charlotte Hieke

Lonza

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For correspondence: annesophie-charlotte.hieke@lonza.com

Chris Williams

Roche

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For correspondence: chris.williams.cw3@roche.com

Susanne Konrad

Roche

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For correspondence: susanne.konrad@roche.com

Joachim Regel

Merck Group

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For correspondence: joachim.regel@merckgroup.com

Sven Verguts

Merck Group

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For correspondence: sven.verguts@merckgroup.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 2

March/April 2025

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A biosafety toolbox for manufacturing with single-use systems

PDA Journal of Pharmaceutical Science and Technology May 2025, pdajpst.2025-000003.1; DOI: 10.5731/pdajpst.2025-000003.1

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A biosafety toolbox for manufacturing with single-use systems

PDA Journal of Pharmaceutical Science and Technology May 2025, pdajpst.2025-000003.1; DOI: 10.5731/pdajpst.2025-000003.1

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Keywords

BSL2
Single Use System
Single Use Operation
Biohazard waste
manufacturing engineering control
best practice of SU solution usage

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Parenteral Drug Association, Inc.