Qualification

Qualification services for industry, pharma and medical sector.

Within our range of services, one of the most important and complete are qualification services oriented to industrial sector (API), pharmaceutical industry and sanitary. The purpose of this service is to check that an equipment or environment behaves appropriately according to the regulations which apply. For this and in different stages of qualification (IQ, OQ, PQ) the installation and performance is compliance regulations.

Different types of qualification ASSI offers in its portfolio of services are:

  • Qualification of thermal equipment and sterilization from -195°C to 1100°C
  • Climate Chambers
  • Refrigerators
  • Freezers and ultra-freezers
  • Cold Stores
  • Incubators
  • Vacuum Stoves
  • Ovens and Muffles
  • Steam Autoclaves
  • Ethylene oxide autoclaves
  • Ovens and depyrogenation tunnels, freeze dryers, washers and disinfectors
  • Freeze dryers
  • Washers
  • Disinfectors
  • Supply Chain Qualification
  • Warehouses
  • Transport Qualification
  • Packaging Qualification (isothermal packaging)
  • Reception Reparation and Expedition times
  • Way of using cold accumulators or freezing witnesses
  • Clean Room Qualification
  • Qualification of laminar flow cabinet, biological safety cabinet, extraction cabinets, Isolators, gas-venting air flow cabinet
  • Qualification activities:
  • Qualification Plan (QP)
  • Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • User Requirement Specification (URS)
  • Protocol writing and execution DQ-IQ-OQ-PQ
  • Risk Assessment (RA)
  • Final Qualification Report
  • Design review and traceability matrix (DQ)
  • Standard Operating Procedure (SOP) preparation
  • Our Qualifications Service
  • Use of high quality standards to guarantee maximum precision in our services
  • Specific standards for calibration of high vacuum freeze dryers
  • Wireless sensors with 0,05ºC precision Maximum measurement accuracy and minimum interference in their processes.
  • High qualified and trained technicians
  • Multidisciplinary team of people to attend all steps of the service with maximum guarantees
  • 20 years’ experience in advising and qualifying equipment