2017 Aseptic Conference, 07-08 March, Hyatt Regency, Reston VA

Learn About Innovative Technologies and
Best Practices in Aseptic Processing!

In its 26th year running, the ISPE 2017 Aseptic Conference continues to drive the evolution of aseptic processing. Keeping the tradition of introducing new technological achievements in the fields of aseptic fill-finish operations such as robotics, sophisticated dispensing systems, and disposables, this signature conference will again summarize innovative and best practices successfully employed to meet the growing complexities for aseptic processing without losing focus on classic Aseptic and Barrier applications.

The two-day ISPE 2017 Aseptic Conference will feature two tracks, Aseptic and Barrier, and will be filled with presentations highlighting aseptic technology updates. 

Special Sessions This Year:    

Day One Opening Keynote, 7 March 2017

What I Learned as Regulator Through Years of International Inspections, Thomas J. Arista, Consumer Safety Officer, FDA/ORA/ORO/DMPTO (Invited)
Get an experienced regulator’s overview of best practices observed and deficiencies discovered, through lifetime of national and international inspections, and how companies deal with these scenarios.

Thomas Arista Photograph
Thomas Arista
Consumer Safety Officer
FDA/ORA/ORO/DMPTO

Day 2 General Session

ISPE-Pew Charitable Trust ISPE and the Pew Charitable Trusts Joint Research Project on Drug Shortages, 7 March 2017
In early 2016, ISPE and The Pew Charitable Trusts had launched a joint research project to explore the relationship between drug shortages of sterile injectable products and US market forces. The research was able to examine the interplay between external market considerations and internal decisions related to business continuity planning, supply chain management, quality, and other drivers. This session will provide an overview of the results from the report to be released in January 2016, which contains findings and potential business and policy insights for regulators, policy makers, and the pharmaceutical industry.

Industry Panel Discussion, 7 March 2017

How to Reach the Point of Fill - Introduction Techniques into the Aseptic Core Area
The introduction of materials into the clean room is one of the most critical operations in aseptic fill-finish. This year’s industry panel will evaluate different technologies used today with their respective advantages and disadvantages. The materials being introduced are equipment, packaging components, microbiological sampling probes and processing aids. Various techniques are available, starting with traditional dry heat/steam sterilization, but also new technologies such as e-beam and NO2-decontamination.

Special Morning Session, 8 March 2017

Update on the ISPE Aseptic Baseline Guide

  • Jason Collins, Director, Process Architecture, IPS
  • Matthew VonEsch, Senior Director, Manufacturing and Facilities, Sigma Tau PharmaSource
  • Gordon Leichter, PhD, Sales Manager, Belimed, Inc.

This presentation will be made by members of the task team tackling the revision of this all important industry guide. Progress has been made and the outstanding industry feedback will be discussed.

Aseptic Track Workshop, 8 March 2017

Leachables and Extractables Are Not the Same
Extractables & Leachables (E&L) have become one of the main issues for Single Use System implementation. Lack of standardization conducts to partial E&L studies, which makes it difficult for end-users to select suitable Single Use components. This workshop will help identify relevant issues, and how to tackle them using risk-based approaches based on an understanding of the biomanufacturing process
.

Special Regulatory Panel, 8 March 2017

This ever popular session will be more interactive this year, with on the spot questions from the regulators to the audience as well as from the audience to the regulators. We will be incorporating a new interactive technology to solicit questions, so come prepared with your smart phones!  

Thank You to Our Program Committee!

Committee Chairs

Jörg Zimmermann Photograph
Jörg Zimmermann
Co-chair (Aseptic Track)
Vice President
Bereichsleiter Vetter Development Service
Vetter Pharma-Fertigung GmbH & Co. KG, Germany
Hite Baker Photograph
Hite Baker
Co-chair (Barrier Track)
Principal Process Engineer
DME, USA

Committee Members

Michael Faia Photograph
Michael Faia
Associate Director
Facilities and Engineering
AstraZeneca, USA
Klaus Ullherr Photograph
Klaus Ullherr
Senior Product Manager
Robert Bosch GmbH, Germany
Klaus Ullherr Photograph
Matthew VonEsch, CPIP
Senior Director of Manufacturing and Facilities
Sigma-Tau Pharma Source, USA

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Presentations & Attendee Roster

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