Articles
RSSTrends In Single-Use Process Systems
November 12, 2007
•Article: Trends In Single-Use Process Systems
As seen in the Fall 2007 Pharmaceutical Online Solutions Update
The pharmaceutical industry's appetite for single-use technologies and information on effective usage of them is one of the fastest-growing industry trends. Disposables are in use in more than 90% of pharmaceutical and biotechnology companies' manufacturing processes. While the core benefits of single-use technologies are well-documented, there is need for more knowledge on implementation and usages. Among these points are integration of multi-component disposable systems, scalability, increasing economic benefits, extractables considerations, disposable facility design, evolving industry guidelines, and new manufacturing models.
Industry Overview
Recently, the Bio-Process Systems Alliance (BPSA), an
industry initiative under the auspices of the Society of
the Plastics Industry, introduced component quality test
matrices for each single-use system subcomponent
class. These matrices, the first in a series of guides
being developed by BPSA, provide quality test methods
and list consensus reference documents along with
testing frequency guidelines to help users select, qualify,
and validate disposable systems and components.
Future guides will address issues including other single-
use system components, sterility claims, extractables
and leachables, and system-based issues.
The industry is also coming together to explore the challenges and advantages of disposable processing. This has resulted in a large number of recent meetings and conferences dedicated to these issues, and many other industry conferences concerned with production and process development issues have included segments on single-use processes. Some of the most talked about subject areas include the increase in multiproduct facilities, manufacturing of personalized medicines and vaccines, converting to single-use technologies, accelerated production in developing countries for export, and the use of disposable technology in animal health.
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