SOP for Cleaning of Clean Area (Sterile Area)

1.0 Objective

To lay down the procedure for carrying out the 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 the 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 µ 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

ANNEXURE

MICROBIOLOGICAL LAB.

CLEANING RECORD OF CLEAN AREA

DISINFECTANT SOLUTION PREPARATION                   DATE				ANY ADDITIONAL/SPECIAL TREATMENT
Sr.No.	Name of Disinfectant	Solution Prepared by	Solution Prepared by	Qty. Ltr.	Checked by

CLEANING RECORDS
Sr.No.	Location	Material/Disinfectant	Frequency	Done by	Checked by
1	Sterility room, Inoculation room, cooling zone & Air locks a. Ceiling b. Walls  c. Floor d.  Hatch	As per schedule	Once in a day
2	LAF bench I, II & III	As per schedule	Once in a day
		70 % IPA	After each test
3	a.Doors & Windows b. Glasses & frames	As per schedule	Once in a day
4	All switch board, Furniture, Platform & Trollies, Wastebins	As per schedule	Once in a day
5	Sterile dress cabinet	As per schedule	Once in a day
6	Culture cabinet	As per schedule	Once in a day
7	HEPA grills & Riser grills	Vacuum Cleaner	Once in a week

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