SOP for Cleaning of Clean Area (Sterile Area) : Pharmaguideline

Online GMP Courses with Certificate

ENROLL

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 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


Get ready to use editable documents in MS-Word FormatView List





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


6 comments: Post Yours! Read Comment Policy ▼

  1. 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?
    Regards
    Mustafiz

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

    ReplyDelete
  3. Thanks for your reply

    ReplyDelete
  4. Sir,
    Can we continue cleaning process while amp/vial inj filling is in process??

    ReplyDelete
  5. would appreciate you to write about cleaning procedure of pharmaceutical warehouse ...thanks

    ReplyDelete

Please don't spam. Comments having links would not be published.


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses


Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg


Recent Posts