Bio-Pharmaceutical

Pharmaceuticals Production, Midwest U.S.
Design and construction of a 5,000 ft2 cGMP pharmaceuticals manufacturing facility, including sterile fill suites for vials, ampoules and ophthalmic solutions.

• Class 100/1,000/10,000/100,000 (ISO 5, 6, 7, 8).
• 68°F ± 2°F & 45% RH ± 5% RH.
• Coved modular wall system, flush grid in sterile LAF areas.
• Purified water, hot & cold WFI, utility & clean steam piping.
• Sterile, high purity gas piping: CDA, N2, CO2, O2.
• Process vacuum, process waste piping systems.
• CO2 & O2 auto switchover panels, vacuum pump.
• Active cascading pressure control system.
• Part 11 compliant facility monitoring system.
• Start-up, test, balance, certification, documentation.

Pharmaceuticals Production, Mexico.
Construction of a 12,500 ft2 sterile pharmaceuticals manufacturing facility, built to cGMP standards.

• Grades A, C, D (Class 100, 10,000, 100,000; ISO 5, 7, 8).
• Coved modular wall system, walkable ceiling grid, custom pass-thru’s.
• WFI plant (vapor compression still) and hot WFI piping.
• Utility & clean steam systems.
• Clean dry air systems.
• High purity process gas piping.
• Process and sanitary waste piping.
• Diesel powered emergency generator.
• Owner equipment hook-up.
• Start-up, test, balance, certification, documentation.

Pharmaceutical Milling Operation, Midwest U.S.
Design and construction of cGMP pharmaceutical milling facility

• Class 100/1,000/10,000 (ISO 5, 6, 7).
• 63°F ± 2°F & 40% RH ± 5% RH.
• Coved, paneled walls, Luwa Membrane Diffusion® ceiling.
• HVAC included charcoal filtration and chemical dryer.
• DDC control system.
• Start-up, test, balance, certification.
• Luwa has completed multiple projects with this customer.