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Project

Dry Powder Inhaler Facility

Location

Spain

Description

Validation & Qualification Services

New building in a multinational company for an inhalation device.Science, Risk Management and process knowledge have been used to identify critical elements and critical aspects in order to perform a successful validation, with documentation commensurate with the risk level.

Scope

Validation Plan, Risk Assessment, DQ, FAT, IQ, OQ, PQ and VPR for:

  • Buildings (Packaging area, Sampling, Compounding, Central heavy, Filling and Finish)
  • HVAC
  • Clean Utilities (WP, WFI, PS, Compressed air, Nitrogen, Vacuum Systems and Gases).
  • Control Systems for HVAC and equipment in clean utilities