The Balancing Act: Maintaining Aging Facilities vs. Facility Modernization As seen in PharmTech.com by David M. Marks, President, DME Facility modernization can be a complex and difficult process even under the best of circumstances, but when one factors in the global regulatory hurdles in pharmaceutical manufacturing, the challenges are significantly greater. However, the reality of aging facilities that must be maintained in a state that is reliable, efficient, and compliant with current good manufacturing practice cannot be avoided. Successful implementation of change must be executed with a good understanding of the challenges associated with introducing new technology and an execution strategy that proactively achieves strategic outcomes. In an industry-wide survey of the life sciences sector conducted by DME in partnership with INTERPHEX, industry insiders—those in[...]
Advanced Aseptic Processing Manufacturing sterile products using aseptic processing is conceivably the most critical process in the pharmaceutical industry. Aseptic processing continues to see critical improvements, especially over the last several decades, and there are new approaches that are transforming traditional aseptic production methods. Hite Baker is a Principal Process Engineer with DME. He is a subject matter expert about sterile formulation, sterile filling lyophilization and barrier isolation. He co-chair’s the Barrier Track for the ISPE Aseptic Conference. He has authored a paper titled: Advanced Aseptic Processing. In this paper, sterile manufacturer stakeholders will discover: Emerging technologies and regulatory guidance for implementing Advanced Aseptic Processing What the industry is saying about their challenges, priorities, and solutions in advanced aseptic technology adoption Considerations in choosing an engineering partner firm Click here for a free download[...]
At INTERPHEX 2016, David Marks, President of DME, was a panelist as part of INTERPHEX Live. The subject was Overcoming Facility Upgrade Challenges. The video of the discussion has been made available and posted here on our website.