Sanitation in Pharmaceutical Industry SOP

Standard Operating Procedure of Sanitation in Pharmaceutical Industry is describe in this post.

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1.0 OBJECTIVE:

To lay down a procedure for the sanitation of pharmaceutical industry sections.

2.0 SCOPE:

This is applicable to general area, tablet production area, manufacturing area, compression/packaging area, clean area, & frequency of cleaning of pharmaceutical industry.

3.0 RESPONSIBILITY:

Sanitary Supervisor.

4.0 ACCOUNTABILITY:

4.1 Head of the Department.

5.0 MATERIAL AND EQUIPMENT:

5.1 Antiseptics and disinfectants.

5.2 Sponge mops.

5.3 Rubber mops.

5.4 Broom.

5.5 Dustbins.

5.6 Baskets and wringers.

5.7 Vacuum cleaner.

5.8 Fogger.

6.0 PROCEDURE:

6.1 PRECAUTIONS:

6.1.1 PERSONNEL PRECAUTIONS:

6.1.1.1 Perform the area cleaning and sanitation when there is no activity.

6.1.1.2 Make sure that a person who is liable to clean the areas has no contiguous disease.

6.1.1.3 Make sure that a person who is liable to clean the areas has changed properly.

6.1.1.4 The manufacturer’s instructions must be followed and protective gears such as gloves, eye shields, aprons, safety footwear, etc. must be used while handling chemicals.

6.1.2 HANDLING OF ANTISEPTICS AND DISINFECTANTS:

6.1.2.1 Handle the disinfectant carefully to avoid contact with skin and eyes. Use only validated disinfectants.

6.1.2.2 Do not use expired disinfectants.

6.1.2.3 Rotate the disinfectants use to avoid the development of resistance by microorganism.

6.1.2.4 Use only dedicated buckets/ containers for preparation and filtration of different disinfectants.

6.1.2.5 Rotate the disinfectants once in a week sequentially, with validated disinfectants and preferably process different spectrum of antimicrobial activity.

6.1.2.6 Disinfectants and cleaning agents should not be mixed. Mixing can result in drastic reduction in antimicrobial activity.

6.1.2.7 Disinfectants and cleaning agents should be freshly prepared.

6.1.2.8 Aqueous dilutions should not be stored overnight as microorganisms can grow on storage.

6.1.2.9 Properly store the chemicals in dry and clean place.

6.1.3 HANDLING OF EQUIPMENTS:

6.1.3.1 Use separate lint free mop and fresh solution cleaning of different area to avoid contamination of mop and solution.

6.1.3.2 Wherever suitable use vacuum cleaner. Ensure that it is in clean and dry condition before use.

6.1.3.3 Properly store the equipments in dry and clean place.

6.1.3.4 Dust mops should not be used to pick up liquids.

6.1.3.5 Discard greasy or oily rags promptly.

6.1.3.6 Dust mop heads should be placed in plastic bags and sent to the laundry when they become very dirty or after each shift.

6.1.3.7 Make sure that all the equipments are easy to use and calibrated.

6.1.4 CLEANING/SANITIZING PRECAUTIONS:

6.1.4.1 Prior to start of the cleaning/sanitizing procedure prepare an adequate quantity of cleaning solutions.

6.1.4.2 Select an appropriate agents based on the solutions that were utilized in the preceding month.

6.1.4.3 Allow the mops to soak in their respective buckets, in solution for approximately 5 minutes prior to the starting of cleaning.

6.1.4.4 Cleaning must occur from the cleanest to the dirtiest areas.

6.1.4.5 Always start at the innermost part of area, cleaning towards the exit when washing floors to avoid walking over cleaned areas.

6.1.4.6 Ensure that every corner of the area is properly cleaned and those of the outside entrance are cleaned with wipe daily.

6.1.4.7 Schedule should be followed as required i.e. daily cleaning, weekly cleaning, monthly cleaning/repairing, three-time cleaning and yearly cleaning/repairing.

6.1.4.8 Where the fumigation is required properly done. Time of fumigation can be validated for better results. And area should be de-fumigated properly before use.

6.2 METHOD:

6.2.1 Firstly take a bucket fill with tap water or as suggested in related SOP of cleaning for specific area. Like in sterile area water for injection is used.

6.2.2 Use disinfectant and antiseptic as per SOP.

6.2.3 Mention the disinfectant and antiseptic as per Annexure on daily basis.

6.2.4 Prepare the disinfectant and antiseptic solutions dilutions as given with instructions.

6.2.5 Following areas to be cleaned:

• Ceiling

• Walls

• Doors, window frames and glasses

• Switches

• Furniture

• Waste bins

• LAF bench

• floor

6.2.6 All area must be cleaned with vacuum cleaner or broom to remove the dust and powder in floors, walls, ceilings and ventilators.

6.2.7 Floor is firstly cleaned with normal water as per SOP of cleaning.

6.2.8 After clean by normal water use detergent solution.

6.2.9 Wet cleaning is done immediately after brooming.

6.2.10 Spillage of any liquid on the floor should be cleaned immediately by rubber mop and floor should be wiped dry.

6.2.11 Follow the frequency of cleaning as per Annexure.

6.2.12 Empty the dustbin regularly.

6.2.13 At the end of the day, drain the excess solution of cleaning agents in drain line wash and dry the empty containers.

6.2.14 Record every day, weekly, monthly or annually cleaning record as per SOP.

6.3 CLEANING AGENTS USED:

Category	Cleaning agents	Active ingredients	Concentration
Antiseptics	Teepol	Sodium benzene sulphonate	0.1%
		Alcohol ether sulphate
		Alcohol ethoxylate
Disinfectants	Lysol	Cresol in soap	1.0%
	Savlon	Cetrimide	1.0%
	Isopropanol	Isopropyl alcohol	70%

6.3.2 In sterile manufacturing areas:

Category	Cleaning agents	Active ingredients	Concentration
Disinfectants	Lysol	Sterile cresol	0.5%
	Savlon	Chlorhexidine gluconate	1.0%
		Cetrimide
		Isopropyl alcohol
	Isopropanol	Isopropyl alcohol	70%

6.4 FREQUENCY OF CLEANING:

Floor and corridor	Daily
Walls	Weekly
Light fixtures and ceiling	Weekly
Corners	Weekly
Benches, cupboards, chairs and door knobs	Daily after production activities
Other repairments	Weekly, monthly or urgent if needed
Paint or others	Yearly

7.0 ANNEXURES:

Cleaning record of Pharmaceutical areas.

Annexure 1:

Annexure 2:

Cleaning record of Pharmaceutical areas.

Annexure 1

Disinfectant solution preparation Date:					Any additional treatment
Sr.#	Name of disinfectant	Solution prepared by	Quantity (liter)	Checked by