Expert Panel Will Address Sterile Manufacturing Challenges

Sterile injectables have been in extremely short supply, and industry efforts have been focusing on root causes involving infrastructure, quality, and efficiency. Pharmaceutical Technology and BioPharm International are sponsoring a Keynote Series discussion on addressing sterile manufacturing challenges on the INTERPHEX 2016 Exhibit Hall Innovation Stage. Admission is free to any attendee with an exhibit hall pass, and the discussion will be held on Wednesday, April 27, from 3:30 to 5:00 pm. Agnes Shanley, Senior Editor of Pharmaceutical Technology, will moderate the discussion. Experts involved in this work will discuss recent initiatives and offer insights into what must be done to prevent injectables shortages in the future. These seven panelists will offer views from different aspects of the industry. 

Maik Jornitz, President, G-CON Manufacturing Inc., will review challenges and issues facing the industry, and what has been learned from the Parenteral Drug Association (PDA) and other studies. G-CON’s POD systems are mobile, self-contained cleanrooms.

Debashis Sahoo, Director of Operations at Medinstill Development LLC will give a perspective on advances in sterile filling technology. The company’s technology involves needle filling and resealing of closed, pre-sterilized containers. Because the containers remain functionally closed, contamination risk is reduced, and the container itself becomes a “mobile isolator,” says the company.

Panelist Chris Procyshyn is CEO of Vanrx Pharmasystems, which uses isolated robotics and machine vision to automate the packaging of injectable drugs. In February 2016, Vanrx and a group of suppliers of aseptic filling and packaging equipment formed the Matrix Alliance to facilitate bringing aseptic filling solutions to the market (http://www.pharmtech.com/packaging-alliance-brings-aseptic-filling-solutions-market).

Panelist Vinod Vilivalam is Senior Director, Daikyo Products and Technologies, Daikyo Seiko, a manufacturer of pharmaceutical packaging and medical device components, is also a member of the Matrix Alliance.

Panelist Anil-Kumar Busimi is director of Strategic Marketing and Innovation at  Schott. Schott AG, which specializes in glass containers, is also a Matrix Alliance member.

Panelists Tim Kram, General Manager N.A., Rommelag and Dr. Martin Haerer, Director Pharmaceutical Affairs, Holopack GmbH, will give another view of technology advances. Rommelag manufactures blow-fill-seal machines for aseptic filling. Holopack has offered contract filling services using blow-fill-seal technology since the company’s founding in 1975.

Panelist Bill Hartzel is Director of Strategic Execution at Catalent Pharma Solutions. Catalent’s Advasept advanced aseptic filling solution uses blow-fill-seal technology. At INTERPHEX 2015, the company launched Advasept Lock, a stopper-less and needle-free vial for delivery of injectable medicines.