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The dispensing area fumigation procedure in pharmaceuticals involves using specialized chemicals to eliminate microbial contamination in production areas, equipment, and storage facilities. This process is crucial for maintaining a sterile environment and ensuring the quality and safety of pharmaceutical products. By effectively targeting and destroying harmful microorganisms, fumigation helps to prevent contamination and maintain compliance with regulatory standards.

Fumigation in Sampling and Dispensing Area

1.0   Objective

• • To lay down the procedure for fumigation in the Sampling and Dispensing Area.

2.0   Scope

• • This SOP is applicable for fumigation in sampling and dispensing areas at pharmaceutical drug manufacturing plants.

3.0   Responsibility

• • Store Officer/ Designee  : To follow the procedure in the dispensing area.

• • QC Chemist/ Designee    : To follow the procedure in the sampling area.

• • Head Store                          : System Compliance for Dispensing Area

• • Head QC                             : System Compliance for Sampling Area

4.0   Procedure Fumigation in Dispensing Area :

• • Materials & Equipment required for Fumigation in Dispensing Area:

• • Gramicide

• • Fogging Machine

• • Safety Goggles

• • Ensure that all the equipment and main electric supply are switched ‘’OFF’’.

• • Ensure that all the equipment and utensils are closed with a lid and shrink wrap.

• • None of the material shall be available in the area.

• • Ensure that air handling units are switched ‘’OFF’’ 30 minutes before the fumigation process is started. Wear hand gloves and a nose mask before starting the activity.

• • Keep the inside doors of the airlock open while fumigation in respective areas.

• • Prepare a 5 % Gramicide solution. Take 150 ml of Gramicide into the fogger holding chamber and

• • add 2.850 liters of purified water to it by using a graduated measuring cylinder.

• • Expose the fumigation fogger in the dispensing area for 2 minutes and in the sampling area for 2 minutes.

• • Lock the main door entrance properly and label the area as ‘’Area under fumigation do not enter’’

• • Record the details for the fumigation of the dispensing area in Annexure-I and the fumigation of the sampling area in Annexure-II.

• • If any area is under continuous operation, fumigation is done as per suitability or after completion of the process.

• • After completion of fumigation kept the area closed for at least 1 to 2 hours.

• • Switch “ON” the AHU for at least one hour before starting the work for de-fumigation.

• • Switch “OFF” the AHU prior to performing the cleaning activity of the area and riser filters.

• • After fumigation, Type A cleaning procedure shall be performed as per SOP.

• • Precaution:

• • Ensure that the area is cleaned.

• • Follow the gowning procedure to enter the area and wear hand gloves, safety goggles, and nose masks during fumigation.

• • Frequency:

• • For dispensing and sampling area 15± 2 days

• • After major maintenance work.

5.0   Annexure

Annexure I:    Fumigation Record for Dispensing Area

 Frequency: 15± 02 days or after major maintenance work.

Annexure II:    Fumigation Record for sampling area

Frequency:  15± 02 days or after major maintenance work.