Cleanroom Validation

Delta-P provides an all-inclusive service in the qualification of cleanrooms.

We offer reassurance that the controlled environment is monitored to your specific requirements and applicable standards.

 

Delta-P offers the following Cleanroom services:

 

Full Cleanroom Qualification

 

Testing and qualification of the clean area over filling processes to ISO 14644 & EU GMP requirements  

 

  • HVAC System Commissioning and Qualification

  • HEPA Filter Leak Testing

  • Airborne Particle Counts Monitoring

  • Airflow Differential Pressures

  • Airflow Volumes, Air Change Rates

  • Room Recovery Tests

  • Bio Safety Decontaimination (Formaldehyde)

  • Airflow Direction/ Visualisation and Videography

  • Sound Level Testing

  • Light Level testing

  • IQ/OQ/PQ- protocol preparation, review and execution

  • Risk Assessment and systems appraisal

  • Preparation and review of Standard Operating Procedures

  • Site HVAC Installation Walk-down and drawing review

  • Troubleshooting HVAC systems in aseptic processing and  general production rooms 

  • Temperature and Humidity mapping service e.g. for any warehouse, cold room or production facility to comply with all regulatory guidelines.

  • Compressed Air /Nitrogen Testing (Particle Count test, Oil and Moisture Sampling)

 

We Specialise in the Validation,Service and Repair of:

 

  • HEPA/UPLA Filters

  • Cleanrooms

  • Laminar Air Flow (LAF) Cabinets on filling lines, capping stations, laboratories etc.

  • Testing & Production Isolators

  • Production Isolators

  • Depyrogenation Tunnels

  • Down Flow Booths

  • Bio-Safety Cabinets

  • Containment Isolators

  • Hospital Operating Theatres (e.g. Charnley enclosures) & High Dependency Units

  • Pharmacy Isolators

  • Air Handling Units (AHU)

  • Fume Cupboards

 

Re-qualification time schedules are set each year with our customers to ensure their Cleanrooms and associated equipment, are kept within calibration and re-qualified. Documentation is provided to respective companies to detail this

re-qualification or verification, which is carried out to cGMP, Regulatory Authorites and all National and International Standards. 

 

Delta-P can offer an all-inclusive project covering maintenance of the HVAC system together with qualification of the cleanroom.  With this approach, efficiency and reliability of the cleanroom environment can be optimised.