"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 has over 20 years of experience in master planning, programming, design, and qualification of biotechnology and pharmaceutical facilities ranging from clinical to full-scale production plants. Sam’s particular focus is in CGMP manufacturing design, including process technology evaluation, capacity analysis, potent compound handling, CGMP environmental classification, and operational analysis. Sam draws from his compliance and process experience to create and develop functionally compliant designs, integrating owner and regulatory requirements.
Sam has developed several unique design tools tailored to the early stages of project development. These design aids include production capacity modeling and assessment, manufacturing flow analysis, manufacturing flow diagrams, process logic diagrams, and environmental classification philosophy diagrams. Sam’s experience is international and he has filled the role as project manager and process lead on major capital projects through construction.
In addition, Sam has presented and lectured on various technology subjects, including containment of highly potent compounds, trends in regulatory requirements, and aseptic design strategies.
Education
- B.S. - Chemical Engineering, Clarkson University
- B.S. - Interdisciplinary Engineering and Management, Clarkson University
Professional Associations
- Parenteral Drug Association (PDA)
- International Society for Pharmaceutical Engineering (ISPE)
Publications
- Halaby, Sam, et al. “Adapting OSD Capital Project Design to Continuous Manufacturing.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX Supplement, April 2016.
- Halaby, Sam, et al. “Looking for a Challenge?” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2015 Supplement, March 2015.
- Halaby, Sam, et al. “Trends in High Tox Manufacturing.” Pharmaceutical Processing, August 2014.
- Halaby, Sam, et al. “Handling Hidden Scale-Up Hazards.” Pharmaceutical Processing, February 2014.
- Halaby, Sam, et al. “Multiproduct Facilities: Considerations Beyond Cleaning.” Pharmaceutical Processing, April 2013.
- Halaby, Sam, et al. “Podcast: Multiproduct Facilities.” 2013.
- Halaby, Sam, et al. “Should it be Scale-up or Scale Out…Bigger is Not Always Better or Faster.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2012 Supplement, March 2012.
Presentations
- Halaby, Sam, et al. “Potent/Toxic Products Session.” ISPE Aseptic Conference, 7 March 2018, Reston, VA.
- Halaby, Sam. “Historical Perspective on Cross-Contamination Regulatory Guidance.” ISPE Annual Meeting & Expo, 2016.
- Halaby, Sam. “Cross-Contamination Workshop.” Pharma Expo Conference, November 2016.
- Halaby, Sam, et al. “Managing Risk of Cross Contamination for Multiple Product Facilities.” Pharma Expo Conference, September 2015.
- Halaby, Sam. “Managing Cross Contamination Risks: Dedication, Segregation or Other?” ISPE Annual Meeting & Expo, November 2015.
- Halaby, Sam. “Tablet Coating Hazardous Risk Management.” L.B. Bohle LLC Tablet Coating Seminar, June 2012, Warminster, PA.
- Halaby, Sam. “Should it be Scale-up or Scale Out… Bigger is Not Always Better or Faster.” 1st Annual Oral Solid Dosage Technologies Tour, INTERPHEX, May 2012, New York City, NY.
- Halaby, Sam. “Design Strategies for Aseptic Manufacturing Facilities.” ISPE CSAC, 2007.
- Halaby, Sam. “Fundamental of High Hazardous (Potent) Compound Safety Course.” IPS & IES Training Course, 2006.
- Halaby, Sam. “Facility Design Strategies for Aseptic Manufacturing.” ISPE NJ & DVC, 2006.
- Halaby, Sam. “Manufacturing Dynamics / Capacity Driven Programming.” CBI Strategic Facility Planning, 2006.
- Halaby, Sam. “Regulatory Issues for the Biotech Industry.” ISPE DVC, 2005.
