11-Year Engineering and Validation Partnership
Embedded engineers in Omrix's engineering and validation departments for more than 11 years, the company's shipping validation program, and engineering for new cleanrooms, laboratories and archives.
The Brief
Omrix, part of Johnson & Johnson, manufactures plasma-derived biosurgical and hemostatic products for markets regulated by the FDA, EMA and other health authorities. The sites need continuous engineering support, a compliant cold chain on every distribution route, and ongoing expansion: new classified cleanrooms, testing laboratories and regulated archives.
What We Do
- Embedded engineering (11+ years): our engineers work inside Omrix’s engineering and validation departments on facility engineering, periodic re-qualification, change control and technical support across the Israeli sites.
- Shipping validation: we run the shipping validation program for the Israeli manufacturing and logistics sites - GDP protocols, qualification of passive and active temperature-controlled containers, data loggers, transit simulations and seasonal lane qualifications.
- New cleanroom suite: we led the preliminary (conceptual) architectural and mechanical design and basis of design, including airflow, pressure cascade and clean utilities.
- Laboratories and archive (in execution): engineering design, fit-out and project management for new QC laboratories and a regulated archive, including vendors, HVAC zoning and commissioning.
Result
A partnership of more than 11 years, aligned with Johnson & Johnson’s corporate standards, covering daily operations, the cold chain and the growth of the site.
Planning a Facility, a Line or a Validation?
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