ORBITAL QUALIFICATION

Qualification and certification of facilities, means and equipment

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Orbital Pharma is accredited by ENAC for the certification of controlled environment facilities and characterization of isothermal media. We also qualify process equipment that requires the highest industry standards.

We can qualify facilities (clean rooms, cabins and controlled environment rooms), machinery (mixers, packaging machines, autoclaves and ovens), computerized management and control systems and also processes in all their phases: design (DQ), installation (IQ), operation (OQ) and process (PQ). In addition, we are accredited to calibrate all types of measuring elements and offer GMP training and quality services for third parties.

A comprehensive service, carried out by fully trained and experienced professionals who will guarantee the perfect operation of your equipment and processes based on the applicable regulations.

Quality assurance

Accreditations

Orbital Pharma is accredited according to the criteria set out in the UNE-EN ISO/IEC 17025 Standard, for testing in the industrial sector for the verification of equipment, components and enclosures such as clean rooms, cabins and controlled environment premises, stoves, incubators, climatic chambers, autoclaves, chest freezers, refrigerators and ovens.

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Auditing, certification, validation, calibration and training

Qualification services

Orbital Pharma offers a wide range of qualification services, either on an ad hoc basis or as part of a comprehensive project:

  • Internal (our specialists work on your company’s audit, providing impartiality and know-how)
  • From third parties (our auditors analyze your suppliers, producers or logistic operators)
  • Facilities
    • Clean room qualification / validation. ENAC accreditation for verification testing of equipment, components and enclosures in the industrial sector for clean rooms, cabins and controlled environment premises. (Determination of class; Differential pressure; Renewals/hour; Determination of velocity; Other determinations)
    • Temperature: ENAC accreditation for isothermal media characterization tests.
    • Qualification of production services: Water (pretreatment, PW, hPW, WFI) and industrial services (nitrogen, steam, compressed air, etc).
  • Machinery
    • Mixing equipment
    • Packaging equipment
    • Autoclaves and Ovens
  • Computerized management and control systems (CFR21)
  • Mixing processes (sterile, liquids and oral and semi-solid solids).
  • Sterile filling and packaging of oral solids and liquids.
  • Cleaning methods.
  • Heat penetration studies.
  • Processes related to production lines.
  • Powder blending, liquid blending, manufacturing validation, etc.
  • Validation of complete industrial processes.
  • Temperature: probes, registers, etc.
  • Pressure: pressure gauges, transducers
  • Mass: scales, etc.
  • Speed: anemometers
  • Revolutions per minute (tachometer)
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Contact us:

Bruc Street, 64
Low. Local 3
08009 Barcelona (Spain)
+34 93 252 02 20
info@reidesen.com

Founding partners of:

Logotipo Global Facilities Group