Cleanroom, Process Equipment and ERP Validation with Audit Support
Engineering and validation partner to LipoSphere - cleanroom improvements, qualification of formulation and filling equipment, ERP validation and support during regulatory audits.
Cleanroom optimizationEquipment URS to PQERP CSVEngineering retainerAudit support
The Brief
LipoSphere develops lipid-based biolubricant nanotechnology and injectable medical devices. It needed one engineering and validation partner to improve its cleanroom operations, qualify specialized process machinery, validate its ERP and support it during regulatory audits.
What We Do
- Cleanroom: guidelines and upgrades for environmental control, pressure cascade and airflow under ISO 14644, and a qualification roadmap for the liposome formulations.
- Process equipment: URS, IQ, OQ and PQ for formulation, mixing and filling machinery, with Validation Summary Reports.
- ERP validation (CSV): GAMP 5, 21 CFR Part 11 and EU Annex 11 validation of inventory, procurement, production tracing, electronic records and user permissions.
- Engineering retainer and audits: day-to-day engineering and maintenance support, and representing engineering and validation during notified body and regulatory inspections.
Result
Inspection-ready cleanroom operations and a compliant ERP, so LipoSphere’s team can scale up under ISO 13485 and CE requirements.
Planning a Facility, a Line or a Validation?
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