Pharma Tips

Laminar Air Flow - Operation & Calibration

By: Pharma Tips | Views: 12624 | Date: 03-Oct-2011

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.


Laminar Air Flow


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.

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