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Sam Halaby

Sr. Director of Process Architecture and Technology

Oral Solid Dosage Expert

Areas of Expertise

 

It is our privilege to present clients with opportunities to evaluate cutting edge technologies, and our responsibility to apply them using proven design methodology, where process fits product, facility supports process, and compliance is inherent.”

- Sam Halaby
Sr. Director of Process Architecture and Technology

Sam is world renowned for his application of “Manufacturing Dynamics” to the design of pharmaceutical facilities and for his collaboration with other industry experts in global compliance, containment philosophy and continuous manufacturing.  Sam’s proven approach is designed to drive process architecture through the clear definition of unit operations and material movement, with the ultimate goal of leveraging analysis tools to optimize production. He is currently the ISPE Co-Chairman of the Containment COP and has formerly been the Chairman for the ISPE Manufacturing Subcommittee and has been a Steering Committee Member for ISPE COP Sterile Products Processing.

Sam  is an INTERPHEX Technologies Tour veteran and highly sought after speaker, whose previous engagements include the following:

Tablet Coating Hazardous Risk Management",  L.B. Bohle LLC Tablet Coating Seminar, 2012

Scale-up or Scale Out…Bigger is Not Always Better or Faster”, 1st Annual Oral solid Dosage Technologies Tour, INTERPHEX, New York, NY, 2012

Environments for Advanced Aseptic Processing”  – ISPE Hyderabad, India 2011

Facility Design Strategies for Aseptic Manufacturing” – ISPE NJ/DVC/CSAC 2006-2007

"Fundamental of High Hazardous (Potent) Compound Safety Course"  2006-2008

"Manufacturing Dynamics / Capacity Driven Programming" – CBI Strategic Facility Planning 2006 

  • p. 888.366.7660

Recent Projects

  • Highly Potent (<1μg/m3) Cytotoxic Compound Clinical Facility Concept and Detailed Design
  • Multi-Step Solvent Based Commercial OSD Manufacturing and Packaging Facility Design and Optimization
  • Master Plan and BOD for Greenfield Campus to Support Large Scale Manufacturing of Highly Potent OSD Products for US, EU and Japanese Markets
  • Containment Strategy for 200ng/m3 Dry Powder Inhalant (DPI) Manufacturing and Packaging Facility Supporting Registration and Commercialization