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Validations and qualifications

SOIMAR’s skills include the preparation and execution of qualification and validation protocols up to the release of products in full accordance with the current legislation.
The validation sector develops both in the field of plants and service systems like air conditioning installations, processed water, pharmaceutical finishes and in the field of production systems such as Bulk, Sterile, Oral and Injection, etc.
The main activities in the sector of validation that SOIMAR develops are:

Document activity:

  • Validation Master Plan
  • Mechanical catalogues and document gathering
  • Assistance during the FAT and SAT phases
  • Preparation and Execution of the DQ, IQ and OQ protocols
  • Preparation of PQ protocols
  • Validation Report Drafting
  • Calibration control and maintenance of critical instruments
  • SOP Preparation

Field activities:

  • Pressure checking and monitoring
  • Verification of thermo-hygrometric conditions
  • Air delivery measuring
  • Particle count
  • Recovery time
  • Smoke Test
  • Microbiological checking
  • Filter integrity Test
  • Laminar flow verification
  • Calibration of critical instruments
2016-04-19T12:40:46+00:00