cgmp fill finish facility design

Designing a technically complex facility for drug product
manufacturing requires both cGMP design expertise and the ability to mitigate
risk through facility programming, layout, and technology selection. O’Neal’s
engineers, designers and subject matter experts leverage these capabilities to
provide innovative, flexible design solutions for both new facilities and
legacy upgrades or renovations.

Risk management is job #1. We understand the issues pharmaceutical
fill finish associated with quality risk management and product contamination
prevention in a cGMP fill/finish facility. Risk-based design is so engrained in
our culture; it touches every aspect of our project delivery.

But we also deliver pragmatic, cost-effective solutions. At the end of the day, what matters most is that your facility is able to manufacture a high-quality product with the capacity, flexibility, and cost of goods that meet your business requirements. O’Neal works with you to design and deliver formulation and filling capabilities—at the appropriate scale to fit your needs and budget.

O’Neal has unique technical capabilities designing sterile
manufacturing facilities. Our experience and expertise in compounding,
lyophilization, RABS & isolators for aseptic processing, single-use
(disposables) technology, and biohazard and potent compound containment are
second to none.

Core Capabilities:

• Pharmaceutical Facility Programming & Layout
• Process/MEP Engineering
• Conceptual, Preliminary & Detailed Design
• Revit 3D CAD / BIM
• Regulatory Compliance
• Cleaning & Sterilization
• Single-Use Technology