Validation Of Laminar Airflow

 

Laminar Air Flow - Operation & Calibration

To lay down a Standard Operating Procedure for laminar flow.

1.OBJECTIVE:
To lay down a Standard Operating Procedure for laminar flow.

2.SCOPE:
This procedure helps to provide standard guidelines to operate and handle the laminar flow. 

3. RESPONSIBILITY:
Operator.
Senior Chemist.
Head - Production.

 

4.PROCEDURE:
4.1 Check and make sure that the area is clean & free from the previous product and any other materials related to previous products.
a. Ensure that the instrument is clean, free from dust and placed in such a position, that any air dust while opening the air-lock door do not affect the positive pressure of the instrument.
b.Switch on the mains.
c.There are three switches and a pressure barometer side panel of the instrument
Switch (1) AIR-FLOW
Switch (2) LIGHT
Press ’switch (1)’ to start the AIR-FLOW through the HEPA Filters
d.The AIR-FLOW should be kept ‘ON’ for about 5 minutes before carrying out any work under laminar flow.
e.Check the level of red-oil indicator should be at 10 to15 mm mark of water column, when AIR-FLOW is ‘ON’.
f.Switch ‘OFF’ the instrument when not in use.

B. CALIBRATION PROCEDURE:
The performance of the HEPA filters could be checked by the following two methods.
(i)DOP (Di Octyl Pthlate) test: (Done on contract basis)
(ii) Anemometer Test: This is one of the suitable tests for validation of the HEPA Filter. During the time of validation, place the anemometric sensor on the Laminar Air Flow at different location in front of the HEPA Filter.
Efficient -- 90 to 110 feet/minute
(iii) Plate method: Prepare nutrient agar plates (or) soyabean casein digests agar plates and exposes it in different corners of the instrument base. Then incubate these plates at 350C for 48 hours. No growth is observed, the HEPA Filter is working in good condition.

C. GENERAL CARE & PRECAUTIONS
Proper handling of the instrument.
Clean the instrument with 70% Iso propyl alcohol, before and after use.
A routine cleaning of filters should be done by blowing air.

D. MAINTENANCE / REPAIRS:
If the instrument does not procedure required calibration results or its response is poor then it should be labeled “FAULTY” and should be repaired or serviced.

 LAMINAR FLOW HOOD AND BIOSAFETY CABINETS

Installation Qualification(Click here to reach web)

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.