Pharmaceutical Technology Europe-12-01-2002

Ultrafiltration is a pressure-driven membrane filtering process used to separate and/or purify dissolved or suspended particles from water and other liquids. Recent advances in materials and membrane manufacturing techniques have led to ultrafiltration playing a pivotal role in a number of biopharmaceutical processes, including protein concentration and blood for actionation. This article examines the criteria that should be considered when selecting membranes for such applications.

Increased competition, industry consolidation and proliferation of products are just a small number of factors putting pressure on pharmaceutical companies to change their traditional business methods. There is a growing focus on improving supply chain efficiencies as a means of optimizing operating margins and financial performance. This article outlines three supply chain types, all of which are identifiable by their product delivery time requirements, which may help pharmaceutical companies streamline supply chain processes and reduce costs.

Spectroscopy using light is a familiar technique and the electromagnetic spectrum from UV to IR is routinely employed. This article looks at the advantages and applications of spectroscopy using sound waves, with special reference to pharmaceutical research.

Residual solvents in pharmaceuticals are organic, volatile chemicals that are either used or produced during the manufacture of actives, excipients or drug products. These chemicals may be hazardous to human health; however, their acceptance limits and classification vary among the three major pharmacopoeia. In this article, the author discusses the regulatory status of the various classifications of residual solvents with regard to the European, US and Japanese pharmacopoeia.

This article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing practice. Compliance with 21 CFR Part 11 for electronic records and electronic signatures was also a major consideration. The procedures used for this project followed the software development life cycle (SDLC) and involved the co-ordination of personnel from the software vendor, the user department, information technology and quality assurance.