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SOP for Cleaning of Clean Area (Sterile Area)

Standard operating procedure to clean the clean area (sterile area).

1.0  Objective

       To lay down the procedure for carry out systematic cleaning of the area which is maintained as clean area (classified area).

2.0  SCOPE

       This cleaning procedure is applicable for 1. Sterility test room,  2. Inoculation room, 3. Airlocks, 4. Cooling zone and also to the equipment situated in clean area such as LAF, culture cabinet  & Dress cabinet.

3.0  Responsibility

3.1  Doing      : Tech. Assistant  (Microbiologist)/Lab Assistant
3.2  Checking : Executive/Manager    

4.0  Accountability

       Head of the Department

5.0  Procedure

5.1  Important note:

       1.  The alternative use of two or more disinfectant is recommended at regular interval to prevent proliferation of resistant strain of micro organisms. 
       2.  The alternative should be of different chemicals type and preferably possess different spectrum of  anti-microbial activity.
       3.  Disinfectants of different chemical types should not be mixed and disinfectants should not be mixed with cleaning agents. Mixing can  results  in drastic reduction in anti microbial activity. 
       4.  Disinfectant and cleaning agents should be freshly prepared .Only  water for injection should be used  for dilution as per need.
       5.  Aqueous dilutions should  not be stored overnight as micro organisms can grow on storage.

Related: Sanitation of Cleanroom Area in Pharmaceutical Manufacturing

5.2  Schedule of disinfectant:

       Sr.No.         Day                  Disinfectant is used       
       01               Monday            2.5% Dettol
       02               Tuesday            10% Solution of Hexcita
       03               Wednesday       1% Solution of Hexcita (Chlorehexidine, Gluconate 7.5%v/v+Cetrimide
                                                  15.0%w/v) (Use Hexcita brand)
       04               Thursday           2.5% Dettol
       05               Friday               10% Solution of Hexcita      
       06               Saturday           1% Solution of Hexcita (Chlorehexidine ,Gluconate 7.5%v/v+Cetrimide
                                                  15.0%w/v) (Use Hexcita brand)
      For Sunday working use 0.1% solution of cleaning agent (Teepol or Cidex spray) (2% w/v solution of glutaraldehyde (use cidex brand).
      Spray the disinfectant with Fogger machine twice in a week on Wednesday & Saturday after end of general shift.
5.3  Prepare required quantity of fresh disinfectant solution using 0.22 ยต membrane filtered water for injection as diluent. Follow the schedule for preparation of disinfectant as per Annexure.
5.4  Clean the entire clean area & Inoculation room using following equipments
       Floor mops
       Cloths and sponges (non fibre shedding)
       Ceiling mops (non particle shedding)
5.5  Following area are to be cleaned
       1  Ceiling 
       2  Walls  
       3  Doors ,window frames & glasses 
       4  Switches 
       5  Furniture 
       6  Waste bins 
       7  LAF bench 
       8  Floor
       9  Sterile dress cabinet
      10  Culture cabinet
      11  Trolly
      12  HEPA grills
      13  Riser grills
      14  Hatch
5.6  Follow the frequency of  cleaning as per Annexure
5.7  At the end of the day, drain the excess solution of cleaning agents and disinfectant in the drain line wash and dry the empty container. 
5.8  Mop the working area with 70% Isopropyl  alcohol daily after completion of sterility test.
5.9  Fumigate the sterility room cooling zone, Inoculation room and air locks with Fogger machine on the week end after work is over.
5.10  Record it in a cleaning record as per annexure.

6.0  Abbreviation

       % = Percentage     
       & = and
       LAF= Laminar Air Flow
       S.O.P.= Standard operating procedure
       IPA= Isopropyl alcohol

Related: Validation for Efficacy of Disinfectants

Name of Disinfectant
Prepared by
Solution Prepared by
Qty. Ltr.

Done by
Checked by
Sterility room, Inoculation room, cooling zone & Air locks
a. Ceiling b. Walls 
c. Floor d.  Hatch
As per schedule
Once in a day

LAF bench I, II & III
As per schedule
Once in a day

70 % IPA
After each test
a.Doors & Windows
b. Glasses & frames 
As per schedule
Once in a day

All switch board, Furniture, Platform & Trollies, Wastebins
As per schedule
Once in a day

Sterile dress cabinet
As per schedule
Once in a day

Culture cabinet
As per schedule
Once in a day

HEPA grills & Riser grills
Vacuum Cleaner
Once in a week

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamE Need Help: Ask Question

3 Comments so far : Add yours...

Mustafizur Rahman said...

Would appreciate you to answer the following query please.
1. What is the procedure of cleaning the floor, wall, ceiling of a manufacturing room (Class D). Is it required purified water for final rinse?
2. Is there any requirement for purified water / Potable water swap after disinfecting the floor of a manufacturing room (Class D)by any disinfecting solution?
3. Is there any Guideline for the above query clear view?

Ankur Choudhary said...

No it is not recommended to clean the walls and ceiling of class D area. Floor should be mopped with disinfectant.

Mustafizur Rahman said...

Thanks for your reply

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