Cleaning and Sanitization of Plant Premises and Equipments

Cleaning and Sanitization of Plant Premises and Equipments

 

1.0 Objective
To describe a procedure for general Cleaning of plant and equipments.
2.0 Scope
This procedure is applicable for general Cleaning of plant and equipments at abc company.
3.0 Responsibility
3.1 All Supervisor of HR & Administration
3.2 Manager/ Head Concern Area
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
HR : Human Resource
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
HOD : Head of Department
5.0 Procedure
5.1 Material Required:
5.1.1 Clean cloths
5.1.2 Liquid Soap
5.1.3 Teepol
5.1.4 Disinfectant
5.1.5 IPA
5.1.6 Mops
5.1.7 Buckets
5.1.8 Wipers
5.1.9 Vacuum cleaner
5.1.10 Toilet Brush
5.2 Method for Cleaning Change Rooms, Store, Utility, Administration, Corridors,

Staircases, Packing hall, QA & QC area :
Clean the floor free from dust with the help of dry mop before mopping the floor.

After that shall do the following activities as per table 1.
5.3 Critical area: Clean the floor free from dust with the help of vacuum cleaner

Before mopping the floor. After that shall do the following activities and record the cleaning as per annexure-I

Area Item Method Cleaning & sanitizing  Agent Concentration

( % v/v)

Frequency
Inside Plant Premise

 

 

Floor Mopping with disinfectant Dettol 2.5 Twice a day
Phenyl 5.0
Doors & windows IPA mopping IPA 70 Weekly
Glass panels Mopping Colin liquid 100 Weekly
Furniture & fixtures Mopping IPA 70 Weekly
Walls & ceiling Mopping IPA 70 Fortnightly
A/C grills Mopping IPA 70 Fortnightly

Note: Disinfectant shall be used alternately to avoid the microbial resistant e.g.
Monday, Tuesday & Wednesday – Dettol 2.5%.
Thursday, Friday & Saturday – Phenyl 5.0%
5.4 Methodology of Cleaning Service floor:
The service floor shall be Cleaned everyday and remove dust with the help of Dry mop.
5.5 Methodology of Cleaning of equipments:
Each equipment which is to be used for operations to be cleaned and sanitized as per their

relevant SOP’s each equipment has the SOP for cleaning and sanitation.
5.6 Methodology of Cleaning Outside area of factory premises:
The outside area of factory premise shall be Cleaned everyday and free from dust with the help of broom.
5.7 Methodology of Cleaning of Toilet
Clean the toilet seat and floor with dilute Domex or toilet cleaner and mop the floor with 2.5 %

Dettol and 5.0% Phenyl alternatively as per below table 2 and record of cleaning as per annexure-II.
Tablet-2

            Area Item Method Cleaning  Agent Concentr-

ation

Frequency
Premises Toilets Toilet Seat     Cleaning Domex /

Harpic

10% v/v Twice a day & on any spillage.
 

 

Floor

Mopping with disinfectant Dettol 2.5 %v/v Twice a day & on any spillage.
Phenyl 5.0 %v/v

Instructions:
1.0 Disinfectant shall be used alternately to avoid the microbial resistant e.g.
Monday, Tuesday & Wednesday – Dettol 2.5%
Thursday, Friday & Saturday– Phenyl 5.0%
2.0 Keep the equipments and materials used for cleaning at the place meant for the same.
3.0 Carefully Handle the Cleaning Agents.
4.0 Storage of cleaning agents and equipment: Housekeeping Room.
5.8 Following area sanitization and cleaning shall be carried out and relevant records to be maintained.
6.0 Forms and Records
6.1 Area Cleaning and Sanitization Record – Annexure-1
6.2 Toilet Cleaning Record – Annexure-2
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Personnel & Administration, Production
8.0 History

Revision Number Details For Change
Reason for Revision
00 New SOP NA
process validation protocol for methylcobalamin niacinamide and pyridoxine injection

validation protocol of sterility test

sop for Analytical Method Transfer

Protocol for hold time study of sterile garments

sop for process validation

sop for swab sampling for validation of clean surfaces

cleaning validation maco and noel calculation formula

sop for performance qualification for analyst

Sop for Validation report for disinfectant efficacy

Sop for Method validation report for bacterial endotoxin test

Sop for method validation microbiology sterility testing

sop for validation report for preservative efficacy test

sop for Protocol cum report for efficacy qualification of uv light

sop for validation protocol for uv light efficacy of dpb & laf

sop for cleaning validation protocol tablet manufacturing equipment



sop for cleaning validation protocol ointment manufacturing equipment

concurrent process validation for rabeprazole ec and domperidone sr capsules

sop for Validation for cleaning procedure liquid injection

sop for Validation for cleaning procedure dry powder injection

sop for validation plan

Preparation Approval Control and Distribution of Master Formula Records

calibration policy for equipment and instruments

sop for stability management

evaluation Sampling of Raw Materials questionnaire

training evaluation questionnaire

sop for approval of Contract Parties

sop for Operation and Cleaning of Purified Water Generation System

sop for Storage of Standard Weights

process validation protocol for methylcobalamin niacinamide and pyridoxine injection

validation protocol of sterility test

sop for Analytical Method Transfer

Protocol for hold time study of sterile garments

sop for process validation

sop for swab sampling for validation of clean surfaces

cleaning validation maco and noel calculation formula

sop for performance qualification for analyst

Sop for Validation report for disinfectant efficacy

Sop for Method validation report for bacterial endotoxin test

Sop for method validation microbiology sterility testing

sop for validation report for preservative efficacy test

sop for Protocol cum report for efficacy qualification of uv light

sop for validation protocol for uv light efficacy of dpb & laf

sop for cleaning validation protocol tablet manufacturing equipment



sop for cleaning validation protocol ointment manufacturing equipment

concurrent process validation for rabeprazole ec and domperidone sr capsules

sop for Validation for cleaning procedure liquid injection

sop for Validation for cleaning procedure dry powder injection

sop for validation plan

Preparation Approval Control and Distribution of Master Formula Records

calibration policy for equipment and instruments

sop for stability management

evaluation Sampling of Raw Materials questionnaire

training evaluation questionnaire

sop for approval of Contract Parties

sop for Operation and Cleaning of Purified Water Generation System

sop for Storage of Standard Weights

sop for Verification of Weighing Balance

sop for Receipt of Returned Goods from Market

Preparation of Master Formula Record MFR

  sop for Leave Policy

     Sop for Submitting of Leave Application

 sop for Accident Management Procedures

sop for Accident Management Procedures

Cleaning and colour coding of Factory Apparel (Clothes)

SOP for 5 S in pharma

Job Responsibilities of Key Personnel

sop for Maintenance of Building

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