Article: Part 1, Bio-Process Systems Alliance Component Quality Test Matrices

By BPSA Guidelines and Standards Committee

Incorporation of single-use bioprocess manufacturing systems has emerged in recent years as a significant trend in the biopharmaceutical industry. In response to the growing demand for single-use systems in biotech and pharmaceutical manufacturing and the challenges of the emerging single-use bioprocessing industry, providers of single-use components, systems, and related services formed an industry organization, the Bio-Process Systems Alliance (BPSA), in early 2006. This alliance was established under The Society of the Plastics Industry, Inc. (SPI) to give greater visibility and a united voice in promoting benefits of single-use manufacturing.

One of BPSA's core activities is to educate and to develop guides that safeguard the quality of drugs produced using this technology. As manufacturers of components and systems, BPSA members can offer extensive expertise and leadership in setting the direction for industry best practices. As one of its first initiatives, the BPSA Guidelines and Standards Committee conducted an initial as appropriate. The alliance looks forward to continuing to enhance the visibility and understanding of such systems. This installment contains matrices for films and containers and for connectors and fittings.

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