Rubrik: Produktion
(Treffer aus cleanroom & processes, Nr. 01, Seite 14 (2026))
Virgilio P
Containment in ADC Facilities / Containment Evaluation and Design Considerations · Virgilio P · Howorth Air Technology
Containment API Evaluation Dispersion Antibody drug conjugate The containment of hazardous substances is a critical aspect of pharmaceutical manufacturing, particularly in facilities handling antibody drug conjugates (ADC). This article explores the principles, evaluation methods, and design considerations for process containment systems, with a focus on ADC production environments. All the information is based on the experience of high containment process design projects in which the author and his workgroup have participated in the last years. Containment isolator design must comply with several European directives and standards. The following is a selection of the most relevant: Annex 1 ("Manufacture of Sterile Medicinal ...