You want an IQ / OQ protocol for your BSCs, laminar flow hoods or ETRAF cabinets
We prepare IQ / OQ protocols and offer qualification of BSCs, laminar flow hoods and ETRAF cabinets in compliance with prevailing standards, GMP (good manufacturing practice) and GLP (good laboratory practice).
We also offer installation qualification / operational qualification of your existing facilities in order to obtain FDA approval.
IQ protocol (installation qualification)
- TEST 1: Verification of the documentation provided.
- TEST 2: Verification of the presence of components and compliance with the specifications and options chosen by the customer.
- TEST 3: Verification of the control panel.
- TEST 4: Verification of the components.
- TEST 5: Visual inspection of the condition of surfaces.
- TEST 6: Testing of the electrical installation.
OQ protocol (operational qualification) for BSCs and hoods as per EN 12469 and ISO 146644-1 or GMP / GLP on request
- TEST 1: Verification of the operation of controls and alarms.
- TEST 2: Absolute filter integrity (Emery, DEHS or DOP test).
- TEST 3: Airflow velocity mapping.
- TEST 4: Verification of particulate class.
- TEST 5: Visualisation of the direction of flow and absence of disturbance and dead zones.
- TEST 6: Measurement of exhaust velocity, validation of the protective barrier and calculation of flow rates.
Protocol (operational qualification) for carbon-filter fume hoods (ETRAF) as per NFX 15211 and NF EN 14 644
- TEST 1: Verification of the operation of controls and alarms.
- TEST 2: Effectiveness of the active carbon cartridge(s) (colorimetric or PID test).
- TEST 3: Absolute filter effectiveness if option chosen.
- TEST 4: Verification of the absence of dead zones (smoke test), verification of the direction of airflow at front intake.
- TEST 5: Measurement of intake velocity.
- TEST 6: Verification of the operation of audio and visual fan alarms.