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GMP Clean Space: “Thinking Outside the Box”

Innovative Solutions for Compliant and Cost Effective Facilities For 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[...]

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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[...]

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North America Technical Center of Excellence Opens

When French-based fragrance and flavors firm Gattefossé needed a new US-based cosmetics R&D Laboratory, they turned to DME to put together a team that would provide a full turnkey solution.  DME partnered with Johnsrud Architects and L.R. Constanzo Construction, both of whom were able to bring a deep resume of experience in laboratory design and construction.  Our history of working together provided to Gattefossé a seamless team of professionals dedicated to this important venture. The project involved renovation of a space adjacent to existing Gattefossé offices in a three-story flexible office building.  The laboratory includes Analytical, Emulsions, Pharma, Cosmetics and Make-up Color Labs. The Technical Center of Excellence brings together pharmaceutical and personal care application laboratories in a 5,300 sq. ft. space with state-of-the-art equipment.  The[...]

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The Balancing Act: Maintaining Aging Facilities vs. Facility Modernization

  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[...]

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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 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[...]

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