Life Sciences & Pharmaceutical
Pharmaceutical, biotech, and life-sciences clients work to a different standard. cGMP, USP, ISO 14644, and EU GMP Annex 1 are not acronyms we look up, they are the everyday vocabulary of our process-design work. We engineer cleanrooms, fill-finish suites, vivariums, BSL-2 and BSL-3 labs, and the WFI, pure-steam, and clean-dry-air systems that feed them. Every line we draw will be inspected by the FDA, EMA, or both, so our designs are built for IQ/OQ/PQ from day one.
Whether the project is a 200,000 sf greenfield drug-substance facility or a single-suite renovation inside an active campus, our process and HVAC teams know how to deliver the validation package the QA group will actually accept.
Our Approach
How We Work
We design process and HVAC systems around the validation package, defining pressure cascades, classifications, and clean utilities so the QA group signs off and the FDA finds nothing to flag.
- cGMP and USP process-design experience
- ISO 5 to 8 cleanroom classifications
- BSL-2 and BSL-3 biocontainment design
Markets Within Life Sciences & Pharmaceutical
Our pharmaceutical work spans the full range of product types, from sterile injectables to supplements.
Representative Project Types
A.Manufacturing & Production
- Drug-substance manufacturing
- Drug-product / fill-finish facilities
- Aseptic processing suites
- Sterile injectable manufacturing
- Biologics & monoclonal antibodies
- Cell & gene-therapy facilities
- Oral solid dose (OSD)
- API & chemical synthesis
B.Research & Laboratory
- R&D laboratory buildings
- Process-development labs
- Analytical & QC laboratories
- BSL-2 & BSL-3 containment labs
- Vivarium & animal research
- Pilot-plant facilities
C.Specialty Systems
- Water for Injection (WFI) systems
- Purified water & clean steam
- Specialty & process-gas distribution
- Acid-waste & bio-waste neutralization
- HVAC pressure-cascade design
- Process piping & sanitary welds
- CIP/SIP & decontamination systems
- Validation & commissioning support
Selected KeRi Experience
Sterile fill-finish, greenfield and fit-out facilities for vials, prefilled syringes, and IV bags, including a high speed triple combi injectable line with Grade A isolators and 703 tons of cooling, and two high-speed injectable lines engineered into a bare 40,000 SF shell. Aseptic Blow-Fill-Seal, a fully aseptic BFS facility with ISO 5 to ISO 8 cleanrooms built inside an existing warehouse. Hormonal & potent compounds, a 90,000 SF topical hormonal plant, an oral solid dose facility with 63 classified rooms, and a potent compound suite designed around containment. Nutraceuticals & softgels, a 200,000 SF supplement plant held at ultra-low humidity, a probiotics suite at 25% RH, and a softgel program engineered to lift capacity from 400 million to 900 million capsules a year. Laboratories & plant assessments, biosimilar R&D, QC, and sensory-evaluation labs, plant-wide dehumidification corrections, and a cGMP HVAC gap analysis across 400,000 SF of manufacturing space.
Why Owners Choose KeRi
Aseptic & Cleanroom Engineering
ISO 5 to ISO 8 suites, isolators, terminal HEPA, and room-by-room pressure cascades for fill-finish, BFS, and syringe lines.
Humidity & Containment Control
Desiccant systems holding rooms as low as 25% RH, and containment that protects operators and products from potent compounds.
Built Inside Existing Buildings
Warehouse and shell conversions and phased work inside operating plants, reusing chillers and air handlers where capacity allows.