Fumigation in Microbiology Laboratory STANDARD OPERATING PROCEDURE

	STANDARD OPERATING PROCEDURE
	Department: Quality Control	SOP No.: QC/MB/xxx
Fumigation in Microbiology Laboratory		Effective Date:
		Review Date:
		Page No.: 1 of 5

1.0            OBJECTIVE:

1.1                 To lay down a procedure for fumigation in Microbiology laboratory.

2.0            SCOPE:

2.1                   This procedure is applicable to all rooms located in microbiology laboratory layout at  Pharma Private Limited.

3.0            RESPONSIBILITY:

3.1                   Housekeeping Supervisor: Responsible for execution of activity.

3.2                   Microbiologist: To Supervise the operation.

3.3                   QC-Head - Responsible for implementing the Procedure.

3.4                 QA Head – Overall compliance

4.0            PROCEDURE:

       Note:  1. Use 200 ml of diluted Steri Line FG liquid (100mL Steriline FG liquid +               100mL purified water) per every 1000 cubic feet of area.

                   2. The fumigator is required 30 minutes of time to disperse the 200mL Steri Line       FG liquid.

3. The Fumigation details like quantity Steri Line FG liquid and fumigation time of each area are mentioned in the Annexure – III.

4.1                 Switch ‘OFF’ the corresponding AHU of the area which is to be fumigated.

4.2                 Place the fumigator in the area to be fumigated and close the doors.

4.3                 Measure the diluted Steri Line FG liquid as per annexure III and transfer to fumigator unit.

4.4                 Switch ‘ON’ the fumigator and allow the fumigator to run for time mentioned in Annexure III for particular area.

4.5                   During this run time the fumigator will disperse the fumigation solution (Steri Line FG) in that particular area.

4.6                 After run time switch off the fumigator take out the fumigator unit from that room.

4.7                     Immediately come out of the room and close the area properly to prevent the fumes from getting out of the room.

4.8                 Allow the area to be exposed with vapors for 3 hours.

4.9                 Follow the fumigation sequence in microbiology lab as given below.

4.9.1             Cool zone (84)

4.9.2             LAF Room – II (83)

4.9.3             LAF Room– I (82)

4.9.4             Culture storage room (81)

4.9.5             Corridor

4.9.6             Change Room II (79)

4.9.7             Incubator Room (112a)

4.9.8             Media Destruction Room (122)

4.9.9             Passage (112)

4.9.10         Micro Office (78)

4.9.11         Change Room I (77)

4.9.12         Autoclave Room (75a)

4.9.13         Media Preparation Room (75)

4.9.14         Media Storage Room (80)

4.9.15         Entry to Media Preparation Room (76)

4.10             Refer fumigation layout of Microbiology laboratory in Annexure I.

4.11             Affix a label as ‘Area under Fumigation’ at the entrance of microbiology          laboratory so that nobody shall enter into the area.

4.12             Switching ‘ON’ the AHU for 2 hours to remove the vapors (defumigation).

4.13             AHU Filters shall be cleaned after defumigation.

4.14             Record the details of fumigation in the Annexure-II.

4.15             Precautions:

4.15.1         Ensure that the operators wear eye protection goggles and nose masks while doing the operation.

4.15.2         Make sure that the return air duct dampers are closed during fumigation.

4.15.3         Ensure that the vapors are completely removed before entering into the areas.

4.16             Frequency: Once in a month ±3days, or after any maintenance activity carried out in the area.

4.17             Cleaning procedure of Fumigator:

4.17.1         Run the fumigator with mild detergent in 100 mL of warm water for 10 minutes.

4.17.2         After this, run the unit with clean cold water for 15 minutes.

4.17.3         Finally run the unit without any liquid (dry run) for 5 minutes.

4.17.4         Outer surface of the fumigator cleaned with lint free cloth.

4.17.5         Frequency: Monthly Once.

5.0           ABBREVIATIONS:

QC: Quality Control	QA: Quality Assurance
SOP: Standard Operating Procedure	AHU: Air Handling Unit
LAF: Laminar Air Flow	mL: Milli Liter

7.0           REFERENCES:

7.1              Instrument Operating Manual