Pharmaceutical Technologist - September 2007 - (Page 36)

Q&A // a structure where suppliers can meet to discuss technical issues and ensure compliance with US antitrust laws and foreign competition laws. Members benefit from participating in committees developing consensus for best practices guides, attending forums to address common technical issues and having access to proprietary market research. One of the first projects the group embarked on was the BPSA quality test. What is this and what benefits does it offer customers? The Component Quality Test Matrices represent a supplier consensus of quality tests applied to single-use components. It provides users with a summary of the test types and what they measure, how often they are applied, and the test references. It serves as a guide to quality criteria for components that can be expected when sourcing single-use systems.1,2,3 What are the future aims of this group? A programme is underway to develop an end-user company membership component to boost interaction between users and suppliers. BPSA is also developing implementation guides for extractables and leachables, and the irradiation, sterilization and disposal of single-use systems. What developments will occur in biodisposables in the future? As it becomes possible to incorporate more units into single-use format, the integration of these systems and the use of automation will become more sophisticated. The emphasis will be on providing fully integrated single-use systems with the various elements being supplied separately and then assembled aseptically on site. There will be more applications in single-use tangential flow filtration and techniques such as ultrafiltration, cell clarification and perfusion cell culture. Ultrafiltration is the most widely-used procedure for protein concentration after purification, and is routinely used for buffer exchange through diafiltration as a method for preparing products for chromatography or for removing inprocess fluids that are not required in the final product formulation. There will also be more developments in disposable sensors for PAT applications and the automation of single-use disposable processes, including stainless frames (with external or disposable sensors) and disposable fluid paths. PT References 1. BPSA Guidelines and Standards Committee, Bioprocess International, 5(4) 52–67 (2007). 2. BPSA Guidelines and Standards Committee, Bioprocess International, 5(5), Supplement 4, 16–23 (2007). 3. J. Martin, Bioprocess International, 5(5), Supplement 4, 12–15 (2007). 36 September 2007 l pharmaceutical technologist

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - September 2007

Contents Editor’s Comment News Morpheus Market Watch CPhI Worldwide 2007 Compliant Pharmaceutical Labelling Q&A

Pharmaceutical Technologist - September 2007

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