Biosafety Cabinets, Laminar Flow Cabinets, Fume hoods and 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 field tests, should be performed by the certifier third party, upon installation, relocation of cabinets, after major maintenance, changing of HEPA filters and when performance is suspected. It is recommended no more than 12 months between certifications, however, many organizations recertify more frequently.
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.
- Biosafety Cabinets (with NSF certification)
A biosafety cabinet is an enclosed, ventilated laboratory workspace for safely working with materials contaminated with pathogens requiring a defined biosafety level. Several different types of BSC exist, differentiated by the degree of biocontainment required such as Class I, Class II (Type A1, A2, B1, B2) and Class III.
SmartCal has NSF 49 Certified Team from United States for all types of Biological safety cabinets and the certificates provided will be with NSF logo.
SmartCal performs comprehensive validation for all classes and types of biosafety cabinets strictly according to NSF49 or EN12469 international standards.
- Laminar Flow Cabinets
A laminar flow cabinet is a carefully enclosed bench designed to prevent contamination of any particle sensitive materials. Air is drawn through a HEPA filter and blown in a very smooth, laminar flow towards the end-user. The cabinet contains no gaps or joints where contamination spores might collect. Such hoods exist in both horizontal and vertical configurations and there are many different types of cabinets with a variety of airflow patterns and acceptable uses.
SmartCal accomplishes the validation of all configurations weather horizontal or vertical according to the international standard ISO 14644.
- Fume Hoods
A fume hood is a type of local ventilation cabinet that is designed to limit exposure to hazardous or toxic fumes, vapors or dusts. Two main types exist, ducted and recirculating (ductless). The principle is the same for both types: air is drawn in from the front (open) side of the cabinet, and either expelled outside the building or made safe through charcoal filtration and fed back into the room.
SmartCal is capable of performing the validation of all types of fume hoods according to the international standard ASHRAE 110 along with the UAE national standard OSHAD CoP 52 or any determined international / national standard.
SmartCal has ASHRAE 110 Certified Team from CETA United States for all types of Fume Hoods.
- 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 its respective international standard for the previous mentioned protective cabinets.
- HEPA/ULPA Filters Leak Test (Integrity Test).
- Inflow Velocity Test.
- Downflow Velocity Test.
- Face Velocity Test (For Fume Hoods).
- Gross Velocity Test (For Fume Hoods).
- Airborne Particle Counting / sterility test.
- Differential Pressure Test (For Pharmaceutical Isolators Only).
- Airflow Visualization Studies (Smoke Test).
- Alarm Verification Test.
- Electrical Safety Test.
- Light Intensity Test.
- UV Light Test.
- Noise Level Test.
- Vibration Test.
- Blower Interlock Test (For BSC Class II, Type B1 & B2).
- Decontamination using H2O2 or Formalin-Ammonia Methods
- More …