Identification and evaluation of cell- growth-inhibiting bDtBPP-analogue degradation products from phosphite antioxidants used in polyolefin bioprocessing materials

X‐ray sterilization of biopharmaceutical manufacturing equipment—Extractables profile of a film material and copolyester Tritan™ compared to gamma irradiation

“…Target compounds involved almost all plastic additives listed in the EP and USP chapters, extractables of polyolefin such as alkanes or linear acids, and degradants of the most common antioxidants such as 2,4-di-tert-butyl phenol (CAS 96-76-4) or the known cell growth inhibiting bis(2,4-di-tert-butyl-phenyl)phosphate (bDtBPP, CAS 69284-93-1), monomers of the copolyester (PCTG), or comparable compounds. 31,32 The extraction solvent pure ethanol is compatible with almost all chromatographic screening methods and no sample preparation is required, which could lead to contaminations or a potential loss of analytes. A solvent exchange, for example, for a derivatization with a silylating agent, can easily be performed by a gentle evaporation with nitrogen and addition of a keeper such as toluene.…”

“…Target compounds involved almost all plastic additives listed in the EP and USP chapters, extractables of polyolefin such as alkanes or linear acids, and degradants of the most common antioxidants such as 2,4‐di‐ tert ‐butyl phenol (CAS 96‐76‐4) or the known cell growth inhibiting bis(2,4‐di‐ tert ‐butyl‐phenyl)phosphate (bDtBPP, CAS 69284‐93‐1), monomers of the copolyester (PCTG), or comparable compounds. 31 , 32 …”

Interaction of leachable model compounds and their impact on Chinese hamster ovary cell cultivation

“…4 Recently, we have described that degradation products from other antioxidants used in SU bioprocessing material can be built by the same degradation pathway and have a T A B L E 1 Overview of the selected leachable model compounds and chemical characteristics comparable effect on cell growth. 17 Butylated hydroxytoluene (BHT) is a very common phenolic antioxidant used in different fields of application, for example, for food packaging material or pharmaceuticals. [18][19][20] Acetophenone is a solvent used in coating, ink and adhesives and found as a volatile after gamma irradiation of medical polymeric material.…”

“…4 comparable effect on cell growth. 17 Butylated hydroxytoluene (BHT) is a very common phenolic antioxidant used in different fields of application, for example, for food packaging material or pharmaceuticals. [18][19][20] Acetophenone is a solvent used in coating, ink and adhesives and found as a volatile after gamma irradiation of medical polymeric material.…”

“…bD t BPP is built during gamma‐irradiation of polyethylene‐based films of SU bioprocessing materials 4 . Recently, we have described that degradation products from other antioxidants used in SU bioprocessing material can be built by the same degradation pathway and have a comparable effect on cell growth 17 . Butylated hydroxytoluene (BHT) is a very common phenolic antioxidant used in different fields of application, for example, for food packaging material or pharmaceuticals 18‐20 .…”