BPSA releases guide to single-use process extractables
To help suppliers of disposable single-use components develop fluid-specific extractables data
The Bio-Process Systems Alliance (BPSA), the US 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 22-page guide is intended to help suppliers and users of disposable single-use components and systems develop appropriate fluid-specific extractables data that may have be applicable in the selection of bio-process components, process validation and regulatory filings.
The guide includes charts and graphs to help users and suppliers initiate and document extractables evaluations that align with FDA Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals.
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.
The new guide can also be ordered online. It is discounted for BPSA members.
The BPSA was established in 2005 to encourage and accelerate the adoption and implementation of single-use manufacturing systems through education, sharing of best practices, development of consensus guidelines and business-to-business networking opportunities.
BPSA is an affiliate of SOCMA Visions, and is managed independently as a non-profit industry trade association.
