Jerold M. Martin

This article outlines methods, validation standards, and documentation of sterilization of single-use products using gamma irradiation.

Single-use manufacturing may seem like a new trend, but it has actually been around for almost 30 years, beginning in the early 1980s when filter manufacturers began to make small process-scale plastic filter capsules to replace "junior" size stainless-filter housing assemblies.

In this quarter's column, highlights from the IBC Single-use Applications meeting, the PDA Single-use Workshop, and the BioProcess systems Alliance International Single-Use Summit are presented.

Developing a quality agreement template for single-use systems.

The author looks at strategies to minimize particle levels in the finished product when using single-use technologies downstream of final capabilities.

Single-use conference roundup.

Although some aspects of single-use components can be standardized, it is unlikely that any materials or design features will become a commodity

BPSA eases confusion over extractables and leachables testing through guides.

Filterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.

Filtration is one of the most commonly used unit operations in the manufacturing of biopharmaceuticals. This is the second part of the fourth article in the "Elements of Biopharmaceutical Production" series. In this second segment, Manoj Menon and Frank Riske present an approach for the development and optimization of a TFF application, followed by a contribution from Jennifer Campbell and Elizabeth Goodrich reviewing key issues involved in validation of a TFF step.