The Bio-Process Systems Alliance (BPSA), the trade association of the single-use bio-processing industry, has released its 2010 technical guide: Recommendations for Testing and Evaluation of Extractables from Single-Use Process Equipment. The guide is available for order at www.bpsalliance.org.
The 22-page color guide is intended as a “best practices” document, to help suppliers and users of disposable single-use components and systems develop appropriate fluid-specific extractables data that may have applicability in risk-based decisions in bio-process component selections, process validation and regulatory filings.
Extractables evaluation in bio-processing is needed to assess the potential impact of process equipment migrants on process intermediates or finished drug product. The guide includes charts, graphs and decision trees to help users and suppliers initiate and document extractables evaluations that align with FDA Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals, and is inclusive of key references and definitions.
The new 2010 Guide is a compendium of recommendations that builds upon the original BPSA Extractables Guide, parts 1 and 2, published in 2007-8, which is available for complimentary download on the BPSA website www.bpsalliance.org.
The latest BPSA Extractable Guides was developed by company experts within the BPSA organization, with specialized knowledge of extractables processes and program testing and evaluation. The document is the result of an 18-month commitment by BPSA volunteers to educate and inform end-users and suppliers of the rigorous requirements and hurdles in undertaking the development of appropriate, documentable extractables and potential leachables data, and to help users and suppliers minimize duplicative testing.
For further information, e-mail Kevin Ott, BPSA Executive Director at [email protected], or go to www.bpsalliance.org.
