By: Maribel Rios, Managing Editor of BioProcess International
The Bio-Process Systems Alliance (BPSA) presented a
single-use applications roundtable on Monday, 30 March 2015, at the
BioPharmaceutical Development and Production (BDP) Week meeting in Huntington
Beach, California. Mark Petrich, PhD (Merck & Co., Inc.) moderated the
panel consisting of Jerry Martin (Pall Corporation), Jeffrey Carter, PhD (GE
Healthcare), James Vogel (The BioProcess Institute), and Todd A. Kapp
(Parker-Hannifin Corporation). Martin started with a historical review of the
BPSA, a trade organization formed in 2005 and now consisting of 46 member
companies (suppliers and end users) whose goal is to “advance single-use
worldwide and facilitate implementation of single-use technologies.”
Carter and
Vogel then reviewed BPSA’s active and recent projects, consisting of the
following:
·
Single-Use Manufacturing Component Quality Test
Matrices (currently under final review and should be available for the BPSA
Annual Summit, 13-15 July 2015, in Washington DC)
·
Change Notification Practices (currently in the
initial stages of documenting)
·
Extractables (currently continuing collaboration
with other organizations such as ASTM, ASME-BPE, and USP)
·
Quality Agreement Template for Single-Use
Biopharmaceutial Manufacturing Products (published July 2014, currently
soliciting feedback from users of the template, with possible future revisions)
·
Particulates Guide, a 12-chapter compendium
addressing why particulates are an issue, how to identify them, and so on
(currently soliciting further input)
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