Extractables and Leachables Assessment of Single Use Systems Used for Biologics

Rubrik: Praxis

(Treffer aus pharmind, Nr. 09, Seite 1200 (2020))

Mogler L | Mahler H | Jahn M

Extractables and Leachables Assessment of Single Use Systems Used for Biologics / Mogler et al. • Extractables and Leachables Assessment · Mogler L, Mahler H, Jahn M · Lonza Drug Product Services, Basel, Switzerland
mapping of the process, including a description of the relevant contact conditions between the materials and the product stream, material risk evaluation, resulting in risk categorization of materials, evaluating existing and prior results (“vendor data”) from quantitative laboratory studies on high risk materials against analytical thresholds derived from safety thresholds, performing quantitative E&L laboratory studies, if the previous step is not conclusive and if quantitative data are required, and proceeding with E&L compounds exceeding safety thresholds, i.e. structure elucidation and toxicological assessments. Abbildung des Prozesses mit einer Beschreibung der relevanten Kontaktbedingungen zwischen Materialien und Produktstrom, Risikobeurteilung des Materials mit dem ...

Contact Angle Measurement on Glass Surfaces of Injection Solution Containers

Rubrik: Originale

(Treffer aus pharmind, Nr. 02, Seite 328 (2013))

Rödel E | Blatter F | Büttiker J | Weirich W | Mahler H

Contact Angle Measurement on Glass Surfaces of Injection Solution Containers / Application of force tensiometry as a tool for contact angle measurement on strongly curved hydrophobic glass surfaces of pharmaceutical packaging containers · Rödel E, Blatter F, Büttiker J, Weirich W, Mahler H · ¹Solvias AG, Kaiseraugst, Schweiz und ²F. Hoffmann-La Roche, Pharmaceutical Development Biologics Europe, Basel, Schweiz und
Contact angle Force tensiometry Glass container Hydrophobicity Polydimethylsiloxane Protein solutions Surface coating Pharmaceutical packaging is a general term for containments ensuring the safe transportation and storage of pharmaceutical products, avoiding contamination and hindering microbial growth. Obviously, pharmaceutical packaging is a critical tool for drug delivery and regulatory compliance. In the pharmaceutical industry primary packaging containers such as vials, syringes, cartridges, or bottles from glass are used for various applications. Therefore, combinations of glass with plastics like in a syringe are frequently used packaging solutions. However, such devices generally require a modification of the glass surface. A common technique for tuning ...