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

Studies of the extractable profiles of bioprocessing components have become an integral
part of drug development efforts to minimize possible compromise in process performance …

The advent of single-use bioprocess systems used for the delivery, storage or manufacture
of biopharmaceuticals has introduced a new potential source for extractables and …

Single-use systems for manufacturing biopharmaceuticals can include filter capsules,
connectors, tubing, and polymeric film biocontainers. In order to tackle the variety of …

The determination of extractable profiles for single-use technologies represents an important
aspect of pharmaceutical production to minimize any possible compromise in drug product …

Plastic materials are widely used in medical items, such as solution containers, transfusion
sets, transfer tubing and devices. An emerging trend in the biotechnology industry is the …

Pharmaceutical packaging/delivery systems and medical devices are characterized via a
controlled extraction study as part of the development process for new pharmaceutical …

Single‐use systems have been increasingly used in biopharmaceutical manufacturing
processes. Despite their multitude of advantages, these plastic and elastomeric assemblies …

The effective management of leachables in pharmaceutical products is a critical aspect of
their development. This can be facilitated if extractables information on the materials used in …

Polymeric materials are often used in pharmaceutical packaging, delivery systems, and
manufacturing components. There is continued concern that chemical entities from …