Pharmaceutical Technologist - September 2007 - (Page 34)

Q&A // disposables to eliminate such concerns. It is now possible to take an empty clean room and install a full biotech cell culture-based manufacturing process with all steps as single use, and have it operating within weeks. A conventional plant would take many months to install and validate, and the cost would be several times higher. Installation and validation costs for a conventional plant can be twice that of the original equipment cost. Pall Corporation is an active member of the Bioprocess Systems Alliance. What are the aims of this group and how does it benefit your customers? The aims of the BPSA are to promote the use of single-use disposable systems by educating suppliers, users and regulators; and develop best practices guides for suppliers, users and to support regulatory inspectors. When introducing new technology in pharmaceutical processing, it is in the interests of the whole industry to adopt common practices to encourage speedy take-up and reduce the problems Complex preassembled sterile single-use systems eliminate the need for operators to connect multiple components. Source: Pall Life Sciences encountered by early users, which can negatively impact the perception of the technology. This benefits end-users through information and recommendations about the best ways to implement single-use manufacturing. It also elevates all supplier members to a higher common level by establishing consensus supplier practices. Developing such consensus user recommendations helps to reduce uncertainty for users. Is the group active in Europe? As an organization under the umbrella of the Society of the Plastics Industry (SPI), with offices in Washington (DC, USA), BPSA’s activities have been US-based. However, membership includes European-based companies and the organization addresses the needs of global customers. What are the benefits of joining? Membership is on a company basis and is limited to suppliers of single-use components, systems integrators and service laboratories. The SPI provides Single-use systems are significantly less expensive than stainless steel systems because the installation and validation costs are lower. Source: Pall Life Sciences 34 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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