Cleaning and Housekeeping Procedure in Pharmaceuticals

1. Introduction

An important factor of quality assurance is good housekeeping. Manufacturing and other operational areas need regular cleaning and disinfection, in order to remove spillage powders, dust and dirt. Cleaning ensures avoidance of cross contamination and to maintain working environment tidy and safe.

2. Objectives

• to facilitate smooth movement of goods and personnel
• to prevent contamination of stored material
• to improve aesthetics
• to avoid mix-ups
• to avoid damage to the goods

3. Equipment needed

• sponge mop
• rubber mop
• broom
• dustbin
• antiseptics & disinfectant

4. Procedure

I General area

• All utensils used in manufacturing area such as scoops, sieves and vessels after use must be cleaned by appropriate cleaning solution.
• After cleaning with solution all equipment rinsed with water, dried and stored covered with polythene bag.
• All area must be cleaned with vacuum cleaner to remove the dust and powder in floors, walls, ceilings and ventilators.
• floor is firstly cleaned with normal water as per SOP of cleaning.
• after clean by normal water use detergent solution.
• The floor must be mopped with 0.1% Teepol and water.
• Oil spillage if any, is wiped off immediately to prevent area contamination with 70% IPA.
• corridor and other operating areas are swept with nylon broom
• wet cleaning is done immediately after brooming

II. Tablet production area

i. Manufacturing area

• clean the powder spillage in compounding area with wet floor mops only
• after the process work is completed and also at the end of the day, clean floors with disinfectant solution as per the cycle
• Use 1% v/v Lysol solution as disinfectant to clean the floor.
• Water spillage should be cleaned immediately by rubber mop.
• Rubbers stoppers and glass pieces if any are collected in a dustbin.
• At the end of the day, floor is cleaned with 0.1% v/v Teepol solution and 1% v/v Lysol solution as disinfectant.
• All glass panes in the non sterile manufacturing area are cleaned using 70% IPA.

CAUTION:

• Do not use brooms to clean compounding area.
• Cotton mop should not be used to clean the preparation area because it may leaves behind cotton fibers.

Related: Validation Protocol for Efficacy of Disinfectants

ii. Compression/packaging area

Good housekeeping may as follow:

• Ensure that all the compression tablets of the previous product have been removed.
• With the help of vacuum cleaner, remove all the dust accumulated on the floor, walls and the exterior surface of the machine.
• Clean all the plastic pallets as well as the floor with the help of wet mop.
• All the accessories of DT apparatus and weighing balance should be properly cleaned before commencing compression of the next product/batch.
• Bring tablet containers of the next product into the production area after properly checking the product name, batch number etc.
• Collect empty aluminum containers and the polyethylene bags, which are used for the product to be compressed.
• Finally ensure that the operator in compression area wears proper hand gloves and moustache cover.

III. Oral liquid production area

i. Compounding area

• Ensure that the compounding equipment and area are clean.
• When the compounding is over, ensure that the equipment is kept at its pre-determined location with proper covering.
• Compounding tank lids are properly closed and on top, cloth cover is put to avoid ingress of insects.
• Bottom outlets of all tanks are covered with a polythene bag.
• Filter press is washed and dried properly.
• Stirrers are covered with polythene bag.
• Small mixing utensils are cleaned, dried and kept inverted on the table.
• Floor is cleaned, washed and dried.
• Hose pipes are cleaned.
• During compounding floor should be kept clean and dry.
• Ensure that the operator wear face masks.

ii. Packing area

• Ensure proper line clearance before starting of any filling/packing line.
• All packaging materials including overprinted materials should be received in full quantity as per indent before starting packaging operation.
• Floor should be kept clean and dry to avoid any accident.
• ROPP caps should be stored in a plastic bucket with a new polybag and covered with lid all the time.
• Filled bottles to be arranged neatly in a clean plastic crate and give status label one inside and one outside the crate.
• All employees working in the area wear clean uniforms.
• Bottle labeling machine should be cleaned and covered properly after use.
• Conveyer belt should be wiped and cleaned daily at the end of the working day.

IV. Ointment production area

• Ensure proper line clearance before starting of any filling/packing line.
• All packaging materials including overprinted materials should be received in full quantity as per indent before starting packaging operation.
• All the packaging materials and product to be packed are arranged in such a way that the product (bulk ointment/cream) identification is easy.
• Packaging material should be stored on plastic pallets and bulk ointment should be stored on trolleys.
• All employees working in the area should wear clean uniforms and should be provided with footwear that adequately covers their feet.
• The floor should be cleaned by the janitor to clean any spillage of bulk/packaging materials.
• Trash from dustbins should be cleared regularly.
• Spillage of any liquid on the floor should be immediately cleared and floor should be dried.
• Ensure the accessories such as SS scoops, spatulas, SS plates etc are cleaned and adequately covered with polyethylene sheets and suitable place.
• The operators responsible for running the filling machine should wear rubber/plastic disposable hand gloves, facemask and moustache covers.

V. Sterile product production area (100 class)

• At the end of day’s operation, promptly remove all unneeded material from the sterile area including reject vials, stoppers etc. via the UV pass box.
• Use only lint free sterile sponges and mops for cleaning and disinfection in the sterile area.
• Prepare approximately 15L of sterile disinfectant solution using sterile distilled water.
• Wipe the entire sterile area using sponges and mops wet with the required concentration of the sterile disinfectant solution, the areas include walls, floors and doors.
• Spray and wipe the exposed surface of all equipment and glass panels using sterile 70% IPA.
• Mop up any liquid or material spilled using sponge wet with the sterile disinfectant solution.
• Wipe the plastic buckets using sterile 70% Isopropanol.
• Wipe the interior of the filling hood using sterile 70% Isopropanol.
• Wipe all UV lamps in sterile area with sterile 70% Isopropanol.
• Wipe the ceiling of the sterile area with sterile 70% Isopropanol in once every week.

Related: SOP for Cleaning of Clean Area

VI. Packaging area

• Ensure that proper line clearance before starting sterile/non sterile packaging for the next product/batch.
• All packaging materials including overprinted materials should be received in full quantity as per indent before starting packaging operation.
• All the packaging materials and product to be packed are arranged in such a way that the product identification is easy.
• Packing materials as well as the bulk tablets should be stored on the plastic pallets.
• With the help of vacuum cleaner, all the dust on the floor and in the wall cleaned periodically.
• Ensure that all the worker in packing department wear clean uniforms.
• Operators who run machine must use masks and hand gloves.
• Empty the dustbin regularly.
• Spillage of any liquid on the floor should be immediately cleaned and floor should be wiped dry.

5. Cleaning agent used

I. In non sterile manufacturing area:

Category	Cleaning agents	Active ingredients	Concentration
Antiseptic	Teepol	a)       Sodium benzene sulphonate b)       Alcohol ether sulphate & c)       Alcohol ethoxylate	0.1%
Disinfectant	Lysol	Cresol in soap	1.0%
	Savlon	a)       Chlorhexidine gluconate b)       Cetrimide c)       Isopropyl alcohol	1.0%
	Isopropanol	Isopropyl alcohol	70%

II.  In  sterile manufacturing area:

Category	Cleaning agents	Active ingredients	Concentration
Disinfectant	Lysol	Sterile cresol	0.5%
	Savlon	a)       Chlorhexidine gluconate b)       Cetrimide c)       Isopropyl alcohol	1.0%
	Isopropanol	Isopropyl alcohol	70%

I. Operator: Responsible for running the machinery smoothly
II. Production supervisor: Responsible for supervise & monitor the employees and operators work. Also fill the various records.
III. Production Officer: Responsible to maintain the area and equipment in a neat, clean and orderly manner.
IV. Production/Plant In-charge: Supervise critical condition (if any).

6. Frequency of cleaning

I. In general area

• Floor & corridor: Daily
• Wall: Weekly
• Light fixtures & ceiling: Weekly
• Corner: Weekly
• Benches, cupboards, chairs & door knobs: Daily after production activities.

II. In tablet area

• After manufacturing
• Floor: Twice a day
• Wall, ceiling & corner: Weekly

III. In liquid area

• After manufacturing
• Floor: Twice a day
• Wall, ceiling & benches: Weekly
• Conveyer belt: Daily
• Filling machine: Before & after production
• Labeling machine: Before cleaning

IV. In sterile area

• Ampule filling room: Daily after use
• Window: Daily
• LAF unit curtains: Daily
• Benches: Daily
• Walls: Daily

Related: Microbial Resistance against Disinfectants

7. Records needed

I. Liquid area

Equipment cleaning records

Last product compounded	Batch no.	Cleaned on	cleaned by	checked by

• Daily floor cleaning record
• Weekly ceiling and corners cleaning record
• Air curtain cleaning record
• Daily filling/packing area cleaning record
• Filling machine cleaning record
• Labeling machine cleaning record etc.

II. General area

• Cleaning tag for general area
• Daily cleaning records
• Weekly cleaning records etc.

III. Sterile area

• Batch manufacturing record
• Batch packing record
• Product batch number, manufacturing and expiry date record
• Microbial count records in sterile area
• Environment monitoring record
• Daily floor cleaning record
• LAF machine running record
• Machine log book etc.

IV. In tablet area

• Batch manufacturing record
• Tablet compression machine running record
• Tablet DT record
• Tablet friability record
• Tablet hardness record
• LOD of the granules record
• Temperature & humidity of the room
• Floor, ceiling & wall cleaning record etc.

Also see: SOP for House Keeping of Stores

Submitted by:

Md. Abdul Bake*¹, MD. Zubair Khalid Labu²

Address:

^*1 Product Development Officer, Gonoshasthaya Pharmaceuticals Limited, Dhaka, Bangladesh

² Head of the Pharmacy Department, World University of Bangladesh, Bangladesh.

Email: Md. Abdul Bake^* - abdul.bake@yahoo.com

          Md. Zubair Khalid Labu - zubairlabu@yahoo.com

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