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DME Provides White Paper for Sterile Manufacturing Stakeholders

DME Provides White Paper for Sterile Manufacturing Stakeholders

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 ProcessingIn 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 of the paper.

This is part of a series of White Papers, entitled Aseptic Technology Trends, part of DME’s overall Facility Focus Program. DME Facility Focus was designed to create a dialog within the industry regarding how we are going to meet the challenges presented by aging facilities, evolving regulatory requirements, new technology solutions and market changes in the pharmaceutical industry. It creates an opportunity to take good concepts and turn them into practical facility designs.

DME’s surveys were designed to touch on areas of both pain and opportunity—areas being transformed by technologies into the future facilities for cGMP manufacturing. They were also developed to help DME and other facility design professionals understand what manufacturers value most in the design of their facilities.

 



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