Standard operating procedure to clean the 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 ofHexcita
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
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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