Isolators Validation


Due to the nature of work carried out in biosafety cabinets, fume hoods, laminar flow cabinets and isolators, a routine performance evaluation or validation and service is essential to ensure that the cabinet is performing well and providing proper protection for the operator, environment and the product. It is not only the requirements of international / national standards but also the strict requirements to self’s own health and safety.

 The validation should be performed by a third party upon installation, relocation of the cabinet, after major maintenance (such as changing HEPA Filters, blowers, etc.) and when performance may be a doubt for the end-user.

 SmartCal has NSF 49 Certified Team from United States for all types of Biological safety cabinets and laminar flow cabinets and we will provide you the certificates with NSF logo.

 SmartCal uses world-class advanced validation tools operated by professional engineers that have had regular trainings and follow strict international standards for the accomplishment of such tasks.

 

  • Barrier Isolators (Pharmaceuticals Isolators)

Isolators provide a physical barrier between the operator and the materials that are being processed or manipulated. This equipment provides a range of personnel and product protection in addition to protection for the surrounding work areas and environment. These units are designed for handling potentially hazardous materials such as chemotherapy agents.

 SmartCal at this extent performs a comprehensive validation for all isolator configurations according to the international standards CETA CAG-002, ISO 14644 and EN12469.

 SmartCal has the total capability to perform all the following tests, each with it’s respective international standard for the previous mentioned protective cabinets.

  • HEPA/ULPA Filters Leak Test (Integrity Test).
  • Inflow Velocity Test.
  • Downflow Velocity Test.
  • Airborne Particle Counting.
  • Differential Pressure Test (For Pharmaceutical Isolators Only).
  • Airflow Visualization Studies (Smoke Test).
  • Alarm Verification Test.
  • Electrical Safety Test.
  • Light Intensity Test.
  • Noise Level Test.
  • Vibration Test.
  • More...