O’Neal will be at INTERPHEX this year!

Join us on October 19-21, 2021 at the Javits Center, NYC


GMP Clean Space: “Thinking Outside The Box”

Innovative Solutions for Compliant and Cost Effective FacilitiesFor INTERPHEX Live (2017), DME assembled a panel of industry experts to discuss innovative solutions for cGMP Clean Space.  DME realizes smart manufacturers are taking a second look at the legacy assumptions and rules of thumb that characterized cleanroom design in the past. Rising costs and space demands are driving creative solutions for more efficient and lower cost cGMP manufacturing. This requires “outside the box” engineering that considers the regulatory requirements, facility program, manufacturing process, CAPEX/OPEX costs, and the latest clean environment construction methods in the context

of quality risk management. The panelists included:

  • Ed Caulkins, Director of Facility Design, DME
  • Blake Hodess, President, Hodess Construction Group
  • Charles Johnsrud, Principal, Johnsrud Architects
  • Tim Loughran, Cleanroom Construction Associates

Click here to watch the video, provided by INTERPHEX, of the panel discussion from INTERPHEX Live: https://www.youtube.com/watch?v=4Z0Iwozian4

DME President Addresses Subject Of Flexible Manufacturing At INTERPHEX Live

At INTERPHEX 2017, David M. Marks, founder and president of DME, was part of INTERPHEX Live panel discussion on the topic: The Future of Flexible Manufacturing.  David has written on the subject and has spoken at several ISPE events on the theme of flexible manufacturing. In “Biopharmaceutical Facilities: What Kind of Flexibility Do You Need?”  he wrote:

Traditional approaches to GMP facility design often tend to focus too early on physical attributes such as square footage or process scale as a function of single-product throughput. This approach neglects the foundational dialog regarding flexibility, proceeding on the assumption that all stakeholders understand and agree on the requirements for the facility. Simply saying that facility flexibility needs to be maximized is inadequate.

Important questions need to be answered to establish the basis of design. Will the facility be used for process development, clinical manufacturing, or commercial production, or for some combination of purposes? Is a phased expansion of capacity planned for the future? What current and future regulatory agencies will the facility have to comply with? Is there uncertainty regarding future manufacturing technologies to be used? Does the manufacturer’s pipeline include products that may require different unit operations or processing at a different scale? Is a shell space or additional utility capacity advisable to handle future process modifications? The answers to these questions, among others, identify what kind of flexibility is most important for a particular facility. This mission should be clearly delineated in the project charter.

We are pleased to make the video of the INTERPHEX Live discussion available here.  As you watch the session, you will find out early that flexibility can have multiple “looks” including expansion, scale and quick change over to new products, to name just a few.


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