Monday afternoon 07 June 2010

Author	Title	Year	Company (Country)	Reftype
Julien, C.	Quality foundation and innovation in single-use systems [Abstract]	2010	Bio Meissner Filtration Products, Inc. (USA)	standard
Abstract: Single-use systems have been adopted by end users as the industry leading value proposition in fluid handling applications, initially for holding buffers and media and progressively for storing and shipping bulk product. The presentation will provide insight into a vendor’s quality foundation borrowing from the principles of quality risk management to establish prequalified dynamic single-use component libraries. Product validation is facilitated through the availability of a vendor’s qualification documentation that includes critical data, e.g., materials of construction and origin, component characterization, sterilization validation, biocontainer integrity, and extractables. Quality-by-design principles in the development of robust welding techniques combined with advanced process control strategies can be implemented to achieve manufacturing capability to address the question of in process biocontainer integrity. Existing PE-based films and a new developed PVDF-based multilayer barrier film along with the applications they each serve in pharmaceutical manufacturing are discussed
BibTeX: @standard{Julien2010, author = {Christian Julien}, title = {Quality foundation and innovation in single-use systems}, journal = {Bio Meissner Filtration Products, Inc. (USA)}, year = {2010}, note = {Bio Meissner Filtration Products, Inc. (USA)} }
Martin, J.	Recommendations for testing extractables and leachables, and the status of the harmonization of testing standards [Abstract]	2010	Bio-Process Systems Alliance and Pall Life Sciences (USA)	standard
Abstract: In 2008, the Bio-Process Systems Alliance (BPSA), the single-use biopharmaceutical manufacturing trade association, published a white paper on supplier recommendations for determination of extractables and leachables from single-use systems. The riskbased approach proposed by BPSA was also presented in a seminar for FDA CBER/CDER and has subsequently served as a practical guide for single-use equipment suppliers and drug manufacturers. In the ensuing two years, the joint supplier/user Technology subcommittee of BPSA has developed an expanded guide to testing for extractables for suppliers and users of single-use components and systems. Based on end-user feedback, some modifications of the materials and safety risk assessment approach are introduced. Component extractables and process fluid migrants are differentiated from final drug product leachables. Consensus recommendations are provided for common extraction conditions and analytical methods to generate applicable extractables data for a range of process fluids and conditions. Such “generic” extractables data, whether initiated by suppliers or users, can limit the amount of migrant or leachables testing necessary, reduce qualification costs and facilitate more rapid implementation of single-use systems. Rationale is also provided for assessment and comparison of existing component data derived under differing conditions by alternate suppliers.
BibTeX: @standard{Martin, author = {Jerold Martin}, title = {Recommendations for testing extractables and leachables, and the status of the harmonization of testing standards}, journal = {Bio-Process Systems Alliance and Pall Life Sciences (USA)}, year = {2010} }
Vanhamel, S.	How to achieve fast track implementation of single-use technology? Overview of Baseline Best Practices in Film Manufacturing Plus Added Steps for Monitoring and Eliminating Defects. [Abstract]	2010	ATMI Life Sciences (Belgium)	standard
Abstract: In the whole single-use concept the polymer-based film is seen as one of the most crucial components from a risk perspective. Still there is little available on standards or guidelines towards film properties, compositions or manufacturing methods. This presentation wants to shed some light on these topics by giving a more practical insight into polymer selection, film manufacturing and converting this film into Bio Process Vessels. What methods are used, what are the risks and how can we reduce or eliminate them?
BibTeX: @standard{Masy2010, author = {Charlotte Masy}, title = {Manufacture of disposables and quality assurance}, journal = {ATMI Life Sciences (Belgium)}, year = {2010} }
Müller, D.	Disposables from the view of the regulatory authority [Abstract]	2010	Regierungspräsidium Tübingen – Leitstelle Arzneimittelüberwachung Baden-Württemberg (Germany)	standard
Abstract: The presentation of Mr. Mueller states the regulatory view on the use of disposable systems in biopharmaceutical manufacturing. This includes applications of single-use systems in active pharmaceutical ingredients production as well as in drug product manufacturing. An introduction followed by an overview of the most important european and international guidelines is given, with emphasis on single-use disposables. Regulatory requirements for typical biopharmaceutical applications are discussed and expectations of an european GMP-inspector are given. GMP-aspects of a comparison of single-use systems versus multi product equipment are presented, especially with regard to cleaning validation and other quality related documentation. Supplier qualification is one important element of ensuring quality for pharmaceutical products, especially when using plastic disposables in production processes. The requirements for a GMP conform supplier management are shown. Additionally Mr. Mueller presents some of his experience as an GMP inspector in biopharmaceutical industry, giving examples of deficiencies found during official GMP inspections.
BibTeX: @standard{Mueller, author = {Daniel Müller}, title = {Disposables from the view of the regulatory authority}, journal = {Regierungspräsidium Tübingen – Leitstelle Arzneimittelüberwachung Baden-Württemberg (Germany)}, year = {2010} }

Created by JabRef on 23/03/2010.