SOP FOR OPERATION AND VALIDATION OF BIOSAFETY CABINET

1.0        Objective:      

               The purpose of this SOP is to provide written procedure for operation and validation        of Biosafety Cabinet.

2.0          Scope:

               This SOP covers operation and validation (In house) of Biosafety Cabinet.

3.0          Responsibility:

               Microbiologist : Responsible for operation, validation and maintenance of the instrument   

               as per procedure.Maintain the required record.

               QA Officer/QA Manager: 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 min before beginning of the work.

4.3                    Switch on the HEPA filter for 15 min before beginning of the work.

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

4.5                    Confirm inward air flow by holding a piece of tissue at the middle of the edge of the viewing panel & ensuring it is drawn in.

4.5          Record the Ultra violet light usage in the Ultra violet light usage log book.(Annexure-1)

4.6          Switch off the instrument once the work completed.

4.7          Decontaminate the interior surface of the Biosafety cabinet 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.

5.2           Plate count method :

5.2.1           Expose soya bean casein digest agar & Sabouraud chloramphenicol agar plates in  

   Biosafety cabinet for 2 hours.

5.2.2           Incubate soya bean casein digest agar plates at 35-37°C for 24 hours and Sabouraud  

              chloramphenicol agar plates at 20-25°C for 72-96 hrs.

5.2.3           Observe the plates & count the no. of colonies found. Record the observations in the 

   Biosafety cabinet log book(Annexure-2).

5.2.4           Acceptance criteria : Not more than 1 cfu per plate/2 hour.

5.2.5           Frequency : Once in a month.

7.0                    Routine maintenance:

7.1          Clean the instrument with dry cloth and Biosafety cabinet bench with IPA.

7.2               Clean the tube of ultraviolet light with dry cloth.

8.0          Documentation:

8.1          Annexure – 1  -  Ultra violet  usage log book.                            XXX/FRM/000

8.2          Annexure – 2  -  Biosafety cabinet 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 Hour	Done by	Checked by
	Start	Stop

SOP No.: XXX/SOP/000              Format No.: XXX/FRM/000-00

Annexure-2
Date	Media used	Plate Exposure Time		Incubation	Results cfu/2 hrs	Done by	Remark	Checked by
		Start	Stop

SOP No.: XXX/SOP/000                Format No.:XXX/FRM/000-00