The biopharmaceutical industry gains enormous flexibility in production processes by using
sterilized preassembled single‐use devices. Gamma irradiation is an established …

Quantitative information on process equipment-related leachables (PERLs) is required for
process qualification and within a safety assessment. Extractables data for single-use …

Plastic components are essential in the pharmaceutical industry, encompassing container
closure systems, laboratory handling equipment, and single-use systems. As part of their …

This paper describes an approach of extractables determination and gives information on
extractables profiles for gamma-sterilized single-use bags with polyethylene inner contact …

This publication describes the development of an experimental set-up and testing protocol
to test the hypothesis that filters used for sterile filtration can act as scavengers of leachables. …

The inhibiting effect of the secondary phosphite antioxidant degradation product bis(2,4-di-tert-butylphenyl)phosphate
(bDtBPP) on cell growth is well-known. The present study …

Polysiloxanes are considered one of the most important commercial families of synthetic
elastomers. They are frequently employed in biopharmaceutical manufacturing equipment as …

Regulatory authorities require the biopharmaceutical industry to demonstrate that extractables
that may migrate from production systems do not alter the safety, efficacy, potency, or …

Sterile filters are ubiquitous in biopharmaceutical manufacturing processes. Because such
filters are in direct contact with the process fluid, profiling of the extractables is of utmost …

Filtration is universally used in biopharmaceutical processing. For example, in upstream
processing for sterilizing-grade filtration of cell culture media or in various downstream …