Standard Operating Procedure for Cleaning and Operation of Fuming Hood

1. Purpose:

To lay down a procedure for Cleaning and Operation of Fuming Hood in the pharmaceutical warehouse.

2. Scope:

The scope of this is applicable for Cleaning and Operation of Fuming Hood in the pharmaceutical warehouse at [company name].

3. Responsibility:

Warehouse Person: Operation and Cleaning of Fuming Hood as per laid down procedure

Warehouse supervisor: To monitor material operation and cleaning operation.

Head Warehouse: Effective implementation of SOP

4. Definitions:

Not Applicable

5. Procedure:

5.1 Operation of Fuming Hood

• The purpose of fuming hood is to dispense the solvents in the safe area where it will prevent the cross contamination and provides safe environment for the operators and supervisor to carryout dispensing activity.

• Ensure that safety precautions are in place and earthling connections are in place.

• Ensure that the material to be dispensed is in approved state.

• Only one material shall be dispensed at one time.

• Ensure that all the accessories and utility required to perform the operation are in place.

• Ensure that all the balances are in calibrated state. Ensure that balance is stabilized for the day and verification is done before performing the activity.

• The operator shall always use Personnel Protective Equipment such as mask and hand gloves, etc.

• Ensure that required cleaning activity is done. The inner surface, surrounding area and panels of fuming hood are clean.

• Switched “ON” the fuming hood from main power supply.

• The switch shall be ‘ON’ to activate the fuming hood.

• Stabilize the fuming hood as per established limit during the qualification. The fuming hood shall be started [specify qualified time] minutes before the dispensing of solvents.

• The dispensing activity shall be carried out within the safe zone.

• Before starting the dispensing activity, perform the line clearance activity.

• Containers in which dispensing is done (pressure vessels) shall be transferred to respective staging area to move it to production area.

• The fuming hood shall be switched ‘OFF’ after completion of dispensing activity.

5.2 Cleaning of Fuming Hood:

• Once the dispensing activity is completed, ensure that the mother containers and containers in which the dispensing activity is done are removed from the fuming hood room and taken to the respective areas.

• Switch “OFF” the power supply to the fuming hood before start cleaning activity.

• Vacuumed cleaner, electrical scrubber machine must not be used in solvent dispensing area for cleaning purpose.

• Spillages on balance platform and floor shall be cleaned with the help of solvent absorbing pad provided by safety department.

• Place the absorbing pad on the spilled solvent. Once the solvent is absorbed using solvent absorbing pad, it shall be disposed by placing it in polythene bag. Transfer the disposal to Effluent Treatment Plant and hand over to the safety department representative.

• Clean the inner and outer panels of fuming hood using fresh dry lint free dusters and subsequently using qualified disinfectant solution as per the cleaning schedule.

• Floor shall be cleaned as per Standard Operating Procedure for Cleaning of Dispensing and Sampling area.

6. Frequency:

• Cleaning of dispensing hood after every operation. If not used for [specify clean equipment hold time period] days, re-clean as per the SOP

• Operation of fuming hood to dispense the solvents used for batch manufacturing or solvent used for any other purposes such as IPA dispensing to produce 70% IPA as a disinfectant.

7. Formats:

7.1 Fuming Hood usage log book

7.2 Fuming Hood cleaning log book

7.1 Fuming Hood usage log book

Sr. No.

Date

Equipment No.

Fuming hood start time

Dispensing start time

Batch No.

Product Name

Material Name

Material Code

A.R. No.

Fuming hood stop time

Dispensed by

Verified by

7.2 Fuming Hood cleaning log book

Date

Time

Equipment No.

Material dispensed for the product

Batch No.

Material Name

Material Code

A.R. No.

Cleaned by

Checked by

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