Sterile Cleanroom and Bioprocess Validation
Ongoing validation of MediWound's sterile cleanrooms, bioprocess and filling equipment and critical utilities, with audit support for FDA, EMA and Israeli MoH inspections.
Cleanroom re-qualificationEquipment IQ/OQ/PQHVAC & utilitiesAudit readiness
The Brief
MediWound produces enzymatic biological therapeutics approved by the FDA, EMA and PMDA, including NexoBrid®, in cGMP sterile facilities. Uninterrupted supply to international markets depends on continuous compliance: environmental control, periodic re-qualification and tight change control over cleanroom utilities and process machinery.
What We Do
- Cleanroom re-qualification: periodic and change-driven IQ/OQ/PQ of the aseptic suites and ISO-classified cleanrooms - differential pressure, HEPA filter integrity, recovery time and airflow visualization.
- Bioprocess and manufacturing equipment: URS, IQ, OQ and PQ for enzymatic extraction, formulation, aseptic filling and packaging systems, closed with Validation Summary Reports.
- Critical utilities: validation oversight of the cleanroom HVAC, process air and clean fluid distribution.
- Audit readiness: engineering and validation support for the quality team during cGMP inspections by the FDA, EMA and the Israeli Ministry of Health.
Result
Continuous cGMP audit readiness and less production downtime across MediWound’s commercial biologics operation.
Planning a Facility, a Line or a Validation?
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