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Oncology

Highly potent oncology injectables in France

In France, for an international pharmaceutical manufacturer: the revamp of an injectables production unit into a highly potent oncology injectables unit to SafeBridge criteria, an €11 million project approved by the FDA and EMA.

  • FDA
  • EMA
Injectable vials and a syringe

Project fact sheet

Client
International pharmaceutical manufacturer
Location
France
Years
2005 à 2008
Engagement
EPCM
Facility
Oncology injectables and solid dosage forms (OEL 5)
Scale
11 M€

Engagement : EPCM

  1. EEngineeringEngineering
  2. PProcurementProcurement
  3. CConstructionConstruction
  4. MManagementManagement
  5. VValidationValidation

Process equipment

  • Freeze dryer
  • Clean-in-place (CIP)
  • Laminar airflow
  • Water for injection (WFI) and pure steam
  • Vaporized hydrogen peroxide (VHP) decontamination
  • High-containment isolator
  • Process cleanroom HVAC
  • Utilities: chilled water, steam, compressed air, nitrogen and effluent treatment

See also

Next project · Tunis, TunisiaPharmaghrebIn Tunis, PBE Expert led an EPCM project for contained oncology and hormonal oral solid dosage forms, approved by the FDA and the EMA.

See alsoProjectsFormAction™

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