bulk pharmaceutical facility design

Handling Active Pharmaceutical Ingredients (APIs) requires a careful balance between safe, compliant manufacturing and efficient production that can succeed in a competitive global marketplace. O’Neal can ensure that your pharmaceutical facility design is up to the challenge.

From chemical synthesis to fermentation and Bulk Pharmaceutical Facilities cell-culture based products, O’Neal brings exceptional experience and expertise in small and large molecule drug substance manufacturing. Our subject matter experts bring a diverse professional background working with API manufacturers, as well as equipment suppliers and consulting firms serving the bulk pharmaceutical industry. This has been a focus of our firm since it was founded, and services supporting facilities for the production of Active Pharmaceutical Ingredients and advanced intermediates continues as our largest market sector.  O’Neal’s engineering team and core capabilities are an excellent fit to the unique requirements of bulk pharmaceutical facility design.

Small molecules, big challenges. Let’s face it; the chemical API market can be brutally competitive. Generic knock-offs and foreign competitors are threatening the viability of many manufacturers. Quality and compliance issues can put you out of business. Aging facilities lack the efficiency and reliability to be competitive in the global market. Special handling is required for low OEL potent compounds, as well as manufacturing processes with flammables and combustibles. To succeed in this economy you need world-class facilities that mitigate these risks and help you keep your edge.

Bulk biopharm is no less challenging. Amid similar competitive pressures coming from biosimilars and an evolving regulatory landscape, large molecule biopharmaceutical manufacturing brings unique challenges. Harnessing the inherent complexity of living organisms, modern biomanufacturing operations need to rely on facilities that are designed with quality risk management in mind.

Core Capabilities:

  • Pharmaceutical Facility Programming & Layout
  • Process/MEP Engineering
  • Conceptual, Preliminary & Detailed Design
  • Revit 3D CAD / BIM
  • Facility cGMP compliance
  • Construction Administration
  • Facility Expansions & Renovations
Subject Matter Expertise:

  • R&D and Pilot Facilities
  • Preclinical Manufacturing
  • cGMP Production Facilities
  • Small and Large Molecule API
  • Bulk Pharmaceutical Chemicals (BPC)
  • Bulk Biopharmaceuticals
  • Potent and Cytotoxic Compounds
  • Oral Solid Dosage (OSD)
  • Liquids, Creams & Ointments
  • Parenteral/Injectable Produc s



















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