Cleanrooms

types

Depending of clients needing, can be chosen the appropriate qualification/validation.

Types of qualification/validation:

• Design Qualification (D.Q.): It will be decided if the project proposed for execution is according with the User requirement;
• Installation Qualification ( I.Q.): It will be decided if the equipment installed or the system complies with project requirements and specifications;
• Operation Qualification (O.Q.): It will be decided if the equipment installed or the system fulfills all the operational parameters within the range and offers the possibility to control them;
• Performance Qualification (P.Q.): It will be decided if the equipments and ancillary systems can operate effectively and steady during normal operation;
• Software Qualification: It will be decided if the software program offers the possibility to control the system.

Examples of mandatory qualification tests (critical):

• HVAC and Cleanrooms:
  • Air flow measurement;
  • Room static air pressure;
  • Temperature and humidity measurement;
  • DOP testing for HEPA / ULPA filters;
  • Particle counting;
  • Microbiological charge.
• For compressed air:
  • Oil content measurement;
  • Dew point measurement;
  • Particle counting;
  • Microbiological charge.

Services:

• Included servies:
  • Drawing up of documentation;
  • Personnel Training.
• Auxiliary Services:
  • Drawing up of AS Built documentation;
  • Site management.
• Our Validation Domanins:
  • HVAC validation;
  • Cleanroom Validation;
  • Software validation;
  • Compressed Air Validation;
  • Purified water validation.

We offer consultancy during the project, providing the know-how. For further information don’t hesitate to contact us.