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CLASS 100 (ISO5) LAMINAR FLOW HOOD AND BIOSAFETY CABINETS

Installation Qualification


The common requirements outlined in the "General" section are required. Additionally, product contact surfaces must be stainless steel or approved plastics or rubber.

Operational Qualification


In addition to the common requirements outlined in the "General" section, the OQ protocol will outline the following tests. HEPA Filter Integrity Test . Photometer readings downstream of the HEPA filter unit will be less than or equal to 0.01% of the upstream challenge. Repaired areas are not to exceed 5% of any filter face area.

Biosafety Cabinet Construction Certification. All welds, gaskets, plenum penetrations and seals will hold pressure within 10% for 30 minutes or be free of soap bubbles after sealed cabinet is pressurized with compressed air to 2" water gauge.

Critical Areas should have laminar airflow of 90 fpm ± 20%, or 28 m/min ± 20%

Airflow, Biosafety cabinets. The calculated average intake air velocity must be between 100-130 fpm or 30-40 m/min

Operational Qualification Acceptance Criteria

HEPA Filter Integrity Test Photometer readings downstream of the HEPA filter unit will be less than or equal to 0.01% of the upstream challenge.

Repaired areas are not to exceed 5% of any filter face area.
Biosafety Cabinet Construction Certification All welds, gaskets, plenum penetrations and seals will hold pressure within 10% for 30 minutes or be free of soap bubbles after sealed cabinet is pressurized with compressed air to 2" water gauge.
Air Velocity Critical Areas should have laminar airflow of 90 fpm ± 20%, or 28 m/min ± 20%
Airflow, Laminar Flow Hoods During average supply air velocity testing, the average reading must be between 120-130 fpm, or 35-40 m/min.
Airflow, Biosafety Cabinets The calculated average intake air velocity must be between 100-130 fpm or 30-40 m/min

Performance Qualification


Airflow will be unidirectional. during smoke testing in the laminar flow zone. During airflow smoke pattern testing in the biological safety cabinet, airflow along the entire perimeter of the work access area will be inward; the smoke will flow downward with no dead spots or reflux within the cabinet; no airflow escape from the cabinet and no billowing over or penetrating the work surface.

The area meets the acceptance criteria for total particulates if the average of the particle concentrations measured at each location falls at or below the class limit. (see below) Any excursion of the class limit for an individual run must be noted, investigated and justified.

Slit to Agar Viable Air Sampling and Viable Surface Sampling results are as shown below. Culture media are positive in growth promotion studies.

Performance Qualification Acceptance Criteria


Smoke Testing Airflow will be unidirectional

During airflow smoke pattern testing, airflow along the entire perimeter of the work access area will be inward; the smoke will flow downward with no dead spots or reflux within the cabinet; no airflow escape from the cabinet and no billowing over or penetrating the work surface.
Total Particulate Counts The area meets the acceptance criteria for total particulates if the average of the particle concentrations measured at each location falls at or below the class limit.

Any excursion of the class limit for an individual run must be noted, investigated and justified.
Slit to Agar Viable Air Sampling less than or equal to 0.1 CFU/ft3
Viable Surface Sampling less than or equal to 2 CFU per 30 cm2
Culture media testing Culture media are positive in growth promotion studies.