Area cleaning and sanitization

Area cleaning and sanitization


To define procedure for cleaning of production and other adjacent area.

  • SCOPE :

This SOP applicable for cleaning and sanitization of furniture, fixture, floor, walls, trolley etc.


3.1       References

  • In House

3.2       Attachments

3.8.1   Attachment -I   : Daily cleaning record

3.8.2    Attachment-II  : Approved disinfectants/cleaning agent, Working Concentration and rotation.

3.8.3    Attachment-III : Disinfectants/cleaning agent Solution preparation log book.


4.1       Concern User department Person:

4.1.1    To ensure cleaning as per defined schedule

4.1.2    To maintain record.

4.3       Head QA Dept. Person

4.3.1    To ensure implementation of defined system. 

4.2       Concern User department Head:

4.2.1    To ensure the record are maintain as per SOP.

4.2.2    To ensure implementation of defined system.


I     Quality Assurance

II    Production

III   Warehouse


6.1       Definitions

6.1.1    Sanitization: Sanitation is the process which ensures removal of micro organisms including pathogenic organisms to a predetermine level from manufacturing premises and facilities.

6.1.2    Cleaning: Cleaning is a procedure which effectively remove residues from manufacturing equipment’s & facilities to a predetermined level or makes reasonably free from contaminants

6.1.3    Cleaning Agents: The specific cleaning use of any commercial cleaning preparation should be   ascertained from the manufacturer before selecting it. As far as possible liquid cleaning agents should be used; since particulate contamination may be caused by cleaning preparations in powder form.

6.2       Abbreviations

6.2.1    QA         : Quality Assurance.

6.2.2    RM        : Raw material.

6.2.3    SOP      : Standard Operating Procedures.

6.2.4    PM        : Packing material

7.0       PROCEDURE :

7.1       Production, Warehouse, Office, Change room and other adjacent area shall be cleaned
daily   as per specified schedule.

7.2       Department supervisor/head shall be responsible maintain cleaning sanitization in their
area and shall maintain cleaning records.

7.3       The production area shall be cleaned daily at the start or end of working and in noon(if applicable) or at the time of change of product/campaign. Detailed frequency is defined under point no. 7.13.

7.4       In case of change in product /product campaign through cleaning and sanitization shall take place.

7.5       Racks, Doors, Windows Trolley, Furniture, Fixture and Computer shall be cleaned first and there after floor cleaning shall be done i.e. High to low height.

7.6       Where the change of contamination or cross contamination persists the cleaning shall be done only using vacuum cleaner in other area de-dusting may be preferred using dry cloth.

7.7       cleaning shall be preferably performed high differential pressure to low differential pressure or more clean area to less clean area

7.7       Cleaning of Trolley, Lift, Furniture, Fixture and Computer,

7.7.1    Clean the material movement trolley, glass panels, furniture & fixtures using muslin cloth
damp with purified water followed by clean dry muslin or lint free cloth.

7.7.2    Clean the computer with dry and clean cloth.

7.7.3    Sanitize the lift platform by moping with disinfectant solution as per Attachment – II and clean wall of lift cage with muslin or lint free cloth.

7.7.4    Clean material movement trolley first with muslin cloth than with cloth damp with purified
water dry with clean muslin or lint free cloth.

7.7.5    Clean all furniture and fixture with dry cloth.

7.7.6    Frequency: As per 7.13

7.8       Cleaning of standard weight and weight box

7.8.1    Clean the Standard Weights using dry and clean muslin cloth followed by muslin cloth/lint
free cloths damp with 70% Isopropyl Alcohol solution.

7.8.2    Clean the Standard Weight Box using damp muslin cloth with purified Water followed by
dry muslin cloth.

7.8.3    Frequency of cleaning is weekly and record in respective SOP.

7.9       Racks, Doors, Windows.

7.9.1    Clean the racks, doors, windows & partitions by wiping with a damp cloth with purified

Water or suitable cleaning agent like Colin followed by dry cloth.

7.9.2    Frequency of cleaning is as per 7.13.

7.10     Walls & Ceiling, Tube lights, Floor under the Pallets/Barrels.

7.10.1  Cover all the containers lying on the pallets/racks by polythene sheet before cleaning.
Clean the walls and ceiling of warehouse by using nylon broom.

7.10.2  Switch off the power supply and clean the tube lights using clean and dry cloth.

7.10.3  Remove the Pallets/Barrels and clean the floor using dry lint free cloth.

7.10.4  Sanitize the floor by moping with disinfectant solution as per Attachment- II

7.10.5  Frequency of cleaning is as per 7.13.

7.11     Cleaning of floor

7.11.1 First of all de-dust all containers, racks with dry duster to remove dust from them or use vacuum cleaner in core area.

7.11.2  Clean the floor with PVC broom in non- core area and collect the waste from floor in poly bag and put it in   waste bin and then remove the poly bag from waste bin and put fresh poly bag in waste bin.

7.11.3  Mop the floor with Liquid soap solution prepared as per attachment II and record the   data of solution preparation log sheet as per attachment III. Than sanitizes the floor by moping it with disinfectant solution prepared as per attachment II and record the data in solution preparation log sheet as per attachment III.

7.11.4  Record the data in attachment I.

7.12     Product change over or campaign end

7.12.1  A through cleaning that included ceiling, walls, light, furniture and fixture shall be performed after completion of product campaign or product change over.

7.12.2  Clean the roof using dry cloths at least twice by using lint free cloth each time. Clean the tube light corners with dry cloth.

7.12.3  Walls shall be cleaned using water and scrubby gently using a cloth. Finally mopped with dry cloths.

7.12.4  While washing the wall using water cover the machine with poly bag particularly electrical connection and electronic parts.

7.12.5  After cleaning the walls, roofs, fixture and furniture clean the machine which cannot Be moved from the area for cleaning.

7.12.6  Finally clean the floor, remove the water spread over the floor using wiper. The machine moping/cleaned with potable water/Detergent solution than clean the area. Clean area manually using mop where cleaning with machine not possible.

7.12.7  Mop all over the area again with potable water if detergent solution is used to clean the area.

7.12.8  Finally mop the area disinfectant solution using generator and frequency specified in attachment -II

7.13     Frequency:

7.13.1  For warehouse and material holing area:

–   Furniture and fixture: weekly

–   Racks, pallets, window and door: weekly

–   Wall ceiling tube lights: fortnightly

–   Floors :     Daily (twice)

–   Drain   :      Weekly on Saturday or last weekly day of week

7.13.2  For processing area and primary packing area:

–   Furniture and fixture: Daily where dust generated is high

–   Racks, pallets, window and door: Weekly or at the time of change in product or
product campaign

–   Wall ceiling tube lights: weekly or at the time of change in product or product

–   Floors : daily (twice)

–   Drain   :      Weekly on Saturday or last weekly day of week

7.13.3  For packing and other areas:

–   Furniture and fixture: Weekly

–   Racks, pallets, window and door: weekly

–   Wall ceiling tube lights: Fortnightly

–   Floors  :    Daily (twice)

–   Drain    :    Weekly on Saturday or last weekly day of week

      8.0  REVISION HISTORY:  
Version No. 00 Effective date
Details of revision:

1.    New SOP


Company logo Company Name & address
Area cleaning and sanitization record Page No. x of y


Date : Sanitizing agent Area Name
Sr. No. Area Details Walls, ceiling, tube lights Furniture & fixtures Racks, pallets, windows, doors Floors Drains Checked by Remarks
Timings Done by Timings Done by Timings Done by Timings Done by Timings Done by
From To From To From To From To From To
  • Frequency may be increase if required

Attachment– II

Company logo Company Name & address
Approved disinfectants/Cleaning agent Working Concentration and frequency Page No. x of y


Sr. No. Disinfectant Working Concentration Frequency
1 Dettol 2.5% V/V Monday & Thursday
2 Lysol    1.0% V/V Tuesday, Friday & Sunday
3 Savlon 2.5% V/V Wednesday & Saturday
4 Teepol 0.1% V/V Daily
5 Liquid soap 2.5% V/V Daily
6 70% Isopropyl alcohal 70%V/V For equipment surface and hand sanitization

 If operation is going on Sunday then Sunday is applicable                                     

 Attachment III

Company logo Company Name & address
Disinfectants/Cleaning Agent Solution Preparation  Log Book Page No. x of y


Date Time Disinfectant /cleaning agent name Qty.  of disinfectant /cleaning agent Qty. of purified water Total Qty. of solution prepared Prepared by Checked by Remarks




About Pharmaguidanaces Channel

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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