SOP for Cleaning and Disinfections of Processing Areas

OBJECTIVE

To provide a cleaning and disinfection procedure for processing areas in order to maintain a tidy and safe working environment, to remove dust and dirt which may affect product quality, to avoid the risk of cross-contamination and to control the bioburden in the production area.

SCOPE

It applies to all the processing areas of XYZ Limited.

RESPONSIBILITY

Operator: To cover the product before cleaning and disinfection & clean the machine/equipment lying in the processing cubicle as per the respective SOP’s.

Cleaners: Cleaning and disinfection operation of processing cubicles.

Production Supervisor: To check the cleaning and disinfection operation.

Q.A. Personnel: To verify the cleaning and disinfection operation periodically and at the time of certifying area clearance for respective operations.

PROCESSING AREAS:

• Granulation and drying room
• Capsule filling room
• Tablet compression room
• Blending room
• Liquids production and packing
• Bulk packing
• Dispensing room

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PRECAUTION

• The cleaning agents and disinfectants require careful handling and protective gears must be used while handling them.
• They should not be mixed together as some of the mixtures may be chemically reactive or may reduce anti-microbial activity.
• They should be used in freshly diluted form as their efficiency may reduce on prolonged storage.

PROCEDURE

• Cleaning procedure for processing areas during a batch changeover, once in a shift and at the start /end of the day/ as and when required.
• Wear a face mask and surgical gloves.
• Ensure that the status label of the machine and area is fixed.
• Arrange the area, tie the polythene bag with nylon thread in case of capsules, residue etc and segregate the product on pallets.
• In case of batch change over remove all materials of the previous batch.
• Ensure that all the containers are covered with their lids.
• Clean the machines of respective processing cubicles as per their respective SOPs.
• Clean the floor with a vacuum cleaner followed by wet moping using a cleaning agent: after which the floor shall be dried by mopping.
• Dispose of the contents of the dustbin.
• Record the cleaning on the log sheet attachment I.
• Clean the mops with water, and the cleaning agent, rinse with purified water and allow to dry.
• Clean the vacuum cleaner as per SOP.

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• Cleaning procedure for processing areas during product changeover.
• Wear a face mask and hand gloves.
• Ensure that the status label of the machine and area is affixed.
• Ensure that all the containers are covered with their lid.
• Remove all the materials of the previous product/ batch.
• Clean the machine of respective processing areas according to product changeover as per their respective SOPs. Clean the weighing balance as per the respective SOPs.
• Clean the entire processing room walls, floor, door, ceiling, glass panels and view panels with a vacuum cleaner to remove the powder, followed by wet mopping and then dry mopping with a lint-free clean cloth.

• Clean the return riser filter as per SOP.
• Wipe the dust extraction pendant with wet mopping followed by dry mopping.
• Clean the electric components like switches, plug tops, cables and the switchboard with a clean dry cloth.
• Decontaminate the non-recoverable residues and dispose of the dustbin contents.
• Clean the floor with a vacuum cleaner followed by wet mopping using an appropriate 1%v/v Cleaning agent solution after which dry the floor by mopping.
• Record the cleaning on the cleaning log sheet.
• Clean the mop with 1% v/v of cleaning solution followed by purified water, and air dry.
• Clean the vacuum cleaner as per SOP.
• Periodical cleaning procedure for processing areas in a shift/day.
• Clean the glass panel, door, walls, electric components, and dustbin once a shift and twice a day as under.
• Clean the glass panel, door and walls with Colin and lint-free cloth.
• Wet mop with a lint-free cloth followed by dry mopping.
• Clean the electric components like plug tops, cables, and switchboards with a clean dry cloth.
• Clean the inner and outer sides of the dustbin by scrubbing with a lint-free cloth soaked in 1% v/v of cleaning solution followed by rinsing with purified water.
• Record the cleaning on the cleaning log sheet.

Disinfection Procedure

• Disinfection of processing areas shall be done once in a shift only when no product is inside the areas.
• Thoroughly clean the processing areas as per the above procedure followed by wet mopping using a chosen disinfectant.
• After disinfection dry the floor by mopping.
• Maintain the disinfection record by logging on the log sheet.
• Clean the mop with an aqueous solution of Liquid Soap followed by water and air dry it.

ATTACHMENTS

Cleaning Log Sheet: Attachment 1

ABBREVIATION

SOP - Standard Operating Procedure.

REVISION HISTORY

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