— Projects
Case Studies
Real-world examples of how 10AR’s engineering expertise has delivered
measurable results for pharmaceutical and biopharmaceutical clients across the globe.
Eliminating Repeat Penetration Studies After a Component Change
A production-driven component swap inside a validated autoclave loading pattern would normally have triggered three full penetration studies. A targeted scientific assessment removed the need
Smart Revalidation: Risk-Based Selection of IQ/OQ Tests
A structured methodology that decides — test by test — which IQ and OQ activities should be repeated, modified, or omitted during annual requalification. Defensible,
A New Sterile Suite for Inhalation Products at a CDMO
Following an FDA mock inspection at a CDMO site, the client built a brand-new sterile production suite engineered, qualified, and inspection-ready for FDA approval of
Saving a Global Manufacturing Facility from Regulatory Shutdown
A critical contamination risk in the sterile water system of a multinational pharmaceutical company’s production facility threatened complete regulatory closure. Through rapid root cause analysis
Building a Phase III Company’s First Sterile Manufacturing Facility
A Phase III biopharmaceutical company required comprehensive engineering support to qualify their new sterile manufacturing facility, establish quality systems, and secure a Contract Manufacturing Organization
Saving a Global Manufacturing Facility from Regulatory Shutdown
A critical contamination risk in the sterile water system of a multinational pharmaceutical company’s production facility threatened complete regulatory closure. Through rapid root cause analysis
Building a Phase III Company’s First Sterile Manufacturing Facility
A Phase III biopharmaceutical company required comprehensive engineering support to qualify their new sterile manufacturing facility, establish quality systems, and secure a Contract Manufacturing Organization
A New Sterile Suite for Inhalation Products at a CDMO
Following an FDA mock inspection at a CDMO site, the client built a brand-new sterile production suite engineered, qualified, and inspection-ready for FDA approval of
Eliminating Repeat Penetration Studies After a Component Change
A production-driven component swap inside a validated autoclave loading pattern would normally have triggered three full penetration studies. A targeted scientific assessment removed the need
Smart Revalidation: Risk-Based Selection of IQ/OQ Tests
A structured methodology that decides — test by test — which IQ and OQ activities should be repeated, modified, or omitted during annual requalification. Defensible,
