Packaging Area Cleaning, Purpose:
Packaging Area Cleaning, To lay down the procedure for effective cleaning at the Packaging Area.
Packaging Area Cleaning, Scope:
This SOP is applicable for the Packaging Area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows:
Operator
[][]To follow the laid down procedure
Executive, Packaging
[][]To monitor and check the cleanliness of area
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
Procedure:
Precaution:
[][]Do not clean/disinfect the area when the packing is running.
[][]Keep the cleaning agents at the designated place only with proper labels.
[][]Ensure that after usage the wet mops are washed and hanged in hanger in cleaner store & allowed to dry. Ensure other cleaning tools are also hanged in hanger after use.
[][]After use of cleaning agent wash hands, feet and fingers thoroughly with soap & plenty of water.
[][]Ensure that during cleaning all the product containers are closed.
[][]Check and ensure that disinfectant solution prepared is not stored for use for the next day and the residue is discarded by pouring into drain.
[][]At least two different disinfectants are to be used alternatively on weekly basis..
[][]Do not mop the floor after keeping Cleaned equipment in clean equipment storage room.
Cleaning Tools / Agents
[][]Portable vacuum cleaner
[][]Cloth & wiper
[][]Potable water
[][]Glass Cleaning agent: ‘Clear View’ (Brand Name).
[][]Disinfectant (Savlon/ Dettol/ Chlotec).
[][]Floor cleaning agent Perfect 7/Enviro Care
[][]Preparation of 2.5 % v/v Chlorhexidine Gluconate Solution
[][]To make 10 L disinfectant solution take 2.5 L Chlorhexidine Gluconate in freshly collected purified water to make up volume up to 10 L).
[][]Stir well to mix the solution properly.
[][]Prepare the disinfectant solution separately in separate bucket for use in different floor.
[][]Maintain the ‘Disinfectant Solution Preparation Record’.
Product to Product Cleaning Procedure (Type-A Cleaning) for Secondary Packaging Area
[][]Type – A cleaning is defined as cleaning procedure followed during product to product changeover.
[][]If the unit/equipment is used for same product it has to be cleaned after 72 hours.
[][]Place the status label ‘TO BE CLEANED’ in the Area.
[][]Clean the ceiling, walls, light fixtures, supply diffusers (SD) and return grills (RG) first with portable
[][]Vacuum cleaner to remove loose dust using a platform trolley, then with wet mop.
[][]Clean the machine/Equipment in packaging are As per SOP.
[][]Clean the doors, windows, compressed air lines and other service lines with dry cloth and then wet mop.
[][]Clean the glasses with ‘Clear View’ solution and wipe.
[][]Clean the control panels, electrical wires with dry cloth.
[][]Clean toolbox, table, log books, SOP folders, hygrometer, stool / chair with dry Cloth.
[][]Clean the floor first with dry mop, then with Perfect 7/Enviro Care and finally with potable water.
[][]Ensure after inspection for absence of any residue of previous product. If any residue of previous product or extraneous matter is found, re-clean the area using above procedure until the area is free of any residue/ extraneous matter.
[][]Remove ‘TO BE CLEANED’ and affix ‘CLEANED’ label in the cleaned area.
[][]Record the cleaning activity in ‘Room Cleaning Log Book’.
Frequency of Cleaning
[][]During product to product change over.
[][]If 72 hours time exceeds after cleaning and the equipment or area is not used, use the equipment or area after performing B-type cleaning.
Batch to Batch Cleaning (Type-B Cleaning) for Secondary Packaging area
[][]Type – B cleaning is defined as cleaning procedure followed during batch to batch changeover of a particular product.
[][]Place the equipment status label ‘PARTIALLY CLEANED’ in the area.
[][]First Clean the floor, ceiling, walls, light fixtures, supply diffusers (SD), return grills (RG) doors, windows and equipment with portable vacuum cleaner to remove the loose dust. Finally clean the floor with wet mop.
[][]Remove ‘PARTIALLY CLEANED’ label and affix ‘CLEANED’ label in the area.
[][]Record the cleaning activity in ‘Room Cleaning Log Book’.
Frequency of Cleaning
[][]During batch to batch change over.
Cleaning at the End of Day’s Operation
[][]Clean external parts of the machine, and operating panel with dry cloth.
[][]Clean the floor first with dry mop and finally with disinfectant solution.
[][]Frequency of Cleaning
[][]At the end of the day’s work.