SOP for Operation and Validation of Laminar Air Flow Hood.

1.0      Objective:

                  To provide written procedure for operation and validation of  Laminar Air Flow Hood.

2.0             Scope:

                  This SOP covers the operation and validation of  Laminar Air Flow Hood.

3.0             Responsibility:

                  Microbiologist: Responsible for operation, validation and maintenance of the instrument. Maintain the required record.

                 QA Officer/QAM: Review the records and governing the document.

4.0             Procedure:

4.1             Switch on the mains.

4.2             Switch on the Ultra Violet light for 30 minutes before beginning of the work.

4.3             Switch on the Laminar flow at least 15 minutes before beginning of the work.

4.4             Ensure that Ultra Violet light is off during working period.

4.5             Check the pressure of Nanometer, lend of the Red liquid indicator. It should be between 5 - 15 mm.

4.6             Record the Ultra Violet lamp usage and pressure of Nanometer in the Ultra Violet lamp usage log book (Annexure-1).

4.7             Switch off the instrument once the work completed.

4.8             Clean the interior surface of the Laminar with 70 % IPA before and after the analysis.

5.0             Validation:

5.1             Check the performance of the HEPA filter by the following methods:

5.1.1          DOP test             : To be performed by external agency.

5.1.2          Particulate count : To be performed by external agency.

5.1.3          Velocity measurement: To be performed by external agency.

                  Frequency           : Once in a year

5.1.4          Plate count method:

5.1.4.1       Expose Soya bean casein digest agar and Sabouraud  Chloramphenicol Agar plates (in

                  duplicate) to air flow for 2 hours.

5.1.4.2       Incubate Soya bean Casein Digest Agar plate at 35- 37° C for 24 hours and Sabouraud Chloramphenicol Agar plate at 20-25° C for 72 to 120 hours.

5.1.4.3       Observe the plate and count the no. of colonies found. Record the observations in the   Laminar flow validation log book (Annexure - 2).

5.1.4.4       Acceptance Criteria:  Not more than 1 cfu per plate/2 hour.

5.1.4.5       Frequency:            Once in a month.

6.0             Routine maintenance:

6.1            Clean the instrument with dry cloth and LAF bench with Isopropyl alcohol.

6.2              Check the level of the red liquid.

6.3              Clean the tube of ultraviolet light with dry cloth.

7.0           Documentation:

7.1          Annexure – 1   -   Ultra Violet usage log book.                          XXX/FRM/000

7.2          Annexure – 2   -   Laminar Air flow validation log book.          XXX/FRM/000

  

8.0            History of Revision:

Revision No.	Effective Date	Revision details	Reason for revision

Annexure - 1
Date	Ultra Violet Lamp Time		Hour Consumed	Total Hours	Pressure of Nanometer	Done by	Remarks
	Start	Stop
SOP No. : XXX/SOP/000-00                                                          Format No. : XXX/FRM/000-00

Annexure - 2
Date	Media Used	Plate Exposure Time		Incubation	Results cfu   / 2 Hour	Done by	Remarks	Checked by
		Start	Stop
SOP No. : XXX/SOP/000-00                                                          Format No. : XXX/FRM/000-00