MPK | SOP FOR THE METHOD OF THE PREPARATION OF DISINFECTANTS IN MICROBIOLOGICAL LAB.

 

 

00/QC/SOP-00	Issue # 01 / June 1st, 20	Page 1 of 3
Prep. By: Microbiologist	Reviewed by: QC  Manager	Approved By: General Manager

 

SOP FOR THE METHOD OF THE PREPARATION OF DISINFECTANTS IN MICROBIOLOGICAL LAB.

Preparation of Disinfectant 

1.0.      Purpose

To describe the method of the preparation of Disinfectants used in Microbiology Lab.

 2.0.      Scope:

This procedure is applicable to the preparation of Disinfectants used in microbiology Lab of Q.A.Department.

2.1.   Extent:

This SOP is extent upto the Microbiology Lab.

 3.0.      Responsibilities

3.1. Quality Control Microbiologist:

To carry out testing and analysis according to set procedure and recording their results in respective records /registers and formats.

3.2. Quality Control Manager:

To approve test and analysis results and initiating corrective and preventive actions if results are non-conforming.

4.0.      Policy Statement or Legal Requirements or General Requirements:

 4.1.   Disinfectants

a.    Isopropyl Alcohol (IPA)

b.    Proceine 40

c.    Klericide CR (Biocide B)

d.    Phenol

e.    Esteem

f.     Lift

4.2.   Glasswares:

a.    Suction Flask

b.    Glass Funnel

c.    Glass Bottles (500 ml)

d.    Filtration Unit

e.    2.5 Liter Amber Glass Bottle

 4.3.   Equipments:

a.    Weighing Balance

b.    Laminar Air Flow

c.    Vacuum Pump

d.    Autoclave

4.4.   Miscellaneous Items:

a.    Spray Bottles

b.    Distilled Water

c.    Millipore Filter 0.22 µ

d.    Whatman Filter

e.    Face Masks

f.     Gloves

5.0.      Procedure:

5.1. Preparation of Disinfectants:

S. No	Action	Responsibility
5.1.1	Isopropyl Alcohol (70%) Measure 700 ml Isopropyl Alcohol and make upto volume 1000 ml with Distilled Water. Application: Use 70% IPA in disinfection of tested Media Petri plates, hands Spray, cleaning of walls, Floors, Roof, SS table, Oven, incubators and working benches.	Microbiologist
5.1.2	Sterile Isopropyl Alcohol (70%) Measure 700 ml Isopropyl Alcohol and make upto volume 1000 ml with Double Distilled Water and Filter the IPA with 0.22 µ Filter under Laminar in Sterile suction flask. After filtration pour the Sterile filtered IPA in Sterile Brown Bottle. Application: Use 70% Sterile IPA in cleaning of Sterility Suite, Laminar, cabinet and in soaking of Sterile products before sterility testing.	Microbiologist
5.1.3	Ethanolic HCl (70%) Measure 700 ml Isopropyl Alcohol and make upto volume 1000 ml with Hydrochloric Acid (HCl). Application: Use 70% Ethanolic HCl in disinfection of tested Media Petri plates.	Microbiologist
5.1.4	Proceine 40 (0.6%) Add contents of sachet to 5 liter of Distilled Water. Mix well in order to homogenize. Allow to contact time of 5 minutes. Application: Use Proceine 40 (0.6%) on hand spray and Mopping.	Microbiologist
5.1.5	Klercide-CR (Biocide B) Dilute 100 ml Klericide in 300 ml Autoclaved Distilled water in 1:3 ratio under Laminar. Application: Use Klercide-CR on floors, walls and hard surfaces of sterility suit.	Microbiologist
5.1.6	Phenol 5% Weight 50 gms Phenol in volumetric flask make volume upto 1000 ml. Mix well in order to homogenize. Application: Use Phenol 5% on roofs, floors, walls and hard surfaces.	Microbiologist
5.1.7	Esteem (2%) Measure 20 ml Esteem in volumetric flask and make volume upto 1000 ml. Mix well in order to homogenize. Application: Use Esteem 2% on floors, walls and hard surfaces.	Microbiologist

 

5.2.: Selection of a Disinfectant for use in a Pharmaceutical Microbiology Lab:

S. No	Action	Responsibility
5.2.1	When selecting a disinfectant for use in a pharmaceutical manufacturing area, the following points should be considered: The number and types of microorganisms to be controlled. The spectrum of activity of commercially available disinfectants. The reputation of the disinfectant supplier. The claims as a sterilant (disinfectants used in Sterility Suite cleaning). The disinfectant or sanitizer supported by the EPA registrations. The concentration. Application method. Contact time of the disinfectant. The nature of the surface material being disinfected and its compatibility with the disinfectant. The amount of organic compounds on the surface that may inactivate a disinfectant. The possible need to maintain a residual bactericidal activity of the disinfectant on the surface. The corrosiveness of the disinfectant to equipment with repeated application. The safety considerations for operators applying the disinfectant. The compatibility of the disinfectant with cleaning agents and other disinfectants. The planned disinfectant rotation.	Microbiologist

 5.3. Precautions:

S. No	Action	Responsibility
5.3.1	Avoid intake of any disinfectants.	Microbiologist
5.3.2	Use face mask, goggles and gloves during preparation of disinfectants.	Microbiologist
5.3.3	Lab coat and head cover should be wear during preparation of disinfectants.	Microbiologist

6.0.      Definitions:

Term/word/statement	Meaning/Description
Disinfectants	Disinfectant chemicals act to disrupt significant cellular structures or processes in order to kill or eliminate microorganisms.
Antiseptics	An agent that inhibits or destroys microorganisms on living tissue including skin, oral cavities, and open wounds.
Sanitizing Agent	An agent for reducing, on inanimate surfaces, the number of all forms of microbial life including fungi, viruses, and bacteria.
Sterilant	An agent that destroys all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. Sterilants are liquid or vapor-phase agents
EPA	Environment Protection Agency

 7.0.      References Used:

S. No	Description
1.	USP 32 / NF 27, 2009, <1072> “Disinfectants and Antiseptics”

 8.0.      List of Records Generated:

S. No	Description of Record
1.	Sterilization Record of 70 % IPA Through Filtration.
2.	Preparation and Consumption Record of Disinfectants.
3.	Inventory Record of Consumption and New purchased Disinfectants.

 9.0.      Referred Document(s):

Document No	Description
Not Available	-

 

10.0.    Annexure:

S. No	Description of Annexure
1.	Sterilization Record of 70 % IPA Through Filtration.
2.	Preparation and Consumption Record of Disinfectants.
3.	Inventory Record of Consumption and New purchased Disinfectants.
4.	The Resistance of Some Clinically Important Microorganisms to Chemical Disinfectants.
5.	General Classification of Antiseptics, Disinfectants, and Sporicidal Agents.
6.	Mechanism of Disinfectant Activity Against Microbial Cells.
7.	Neutralizing Agents for Common Disinfectants.
8.	Typical Surfaces to be Decontaminated by Disinfectants in a Pharmaceutical Manufacturing Area / Microbiology Lab.

6.0 Distribution:

6.1     Central Quality File.

6.2     Quality control Manager

6.3.       Quality Control Analyst

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