Pharmaceutical Technology-11-01-2008

Pharmaceutical Technology

Manufacturing High-Potency Drugs Using Isolators

November 01, 2008

Articles

2008 Supplement

6

The author discusses the key issues to consider when using isolators such as containment, protection of personnel, the efficiency of biodecontamination cycles, sterility assurance levels, barriers and their integrity, and environmental impact.

Improving the Integrity Test Assurance of Multiround Housings Assessments

November 01, 2008

Articles

2008 Supplement

6

The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.

Comparison of Conventional Cleanrooms, Restricted Access Barrier Systems, and Isolators

November 01, 2008

Online Exclusive

2008 Supplement

6

A comparison of conventional cleanrooms, restricted access barrier systems, and isolators, shows the benefits of using isolators in high-potency drug manufacturing.

USP <1117> "Microbial Best Laboratory Practices": An Interview with Scott Sutton

November 01, 2008

Online Exclusive

2008 Supplement

6

Scott Sutton discusses the current state of USP ‹1117› and USP's plans for future revisions.