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

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.

PEOPLE ALSO READ: SOP for Flow of Batch Records

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 contents of the dustbin.
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 the 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 side 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 there is no product inside the areas.
Thoroughly clean the processing areas as per 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 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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