SOP for preparation of cleaning and disinfectant solution in Production/ Warehouse/Quality control

  SOP for preparation of cleaning and disinfectant solution 

This SOP is for preparation of cleaning and disinfectant solution used in Production/ Warehouse/Quality control which helps to understand how to prepare cleaning and disinfectant.

 

1. OBJECTIVE

To lay down procedure for preparation of cleaning and disinfectant solution in pharmaceutical industries.

2. SCOPE

This standard operating procedure for preparation of cleaning and disinfectant solution is applicable in  pharmahub Ltd Unit-I, Roorkee.

 3. RESPONSIBILITY

 Jr. officer/ officer/ Warehouse Executive

4. ACCOUNTABILITY

Department manager/ Department head

SOP

5. PROCEDURE

 5.1DEFINITION:

 5.1.1 Cleaning Agent are materials, which help to remove extraneous material from surfaces and  objects.

5.1.2 Disinfectants are potent substances, which destroy pathogenic micro-oraganisms but not necessarily resistant spores and are usually applied on inanimate objects.

5.1.3  Antiseptics are reasonably non-toxic substances and may be applied to live tissue for killing micro-organisms or to prevent their growth

 5.2 Preparation of cleaning  Solution (Teepol 1%v/v ):

 5.2.1 Take a clean transparent plastic Measuring cylinder.

5.2.2 Take 50ml Teepol solution in a 10 liter SS container and make up to volume 5 liter.

5.2.3 Mix the solution with an SS rod.

5.2.4 Transfer in a suitable plastic container  and close the lid/cap  of the container.

5.2.5 Prepare the Teepol solution label affix on the container label.

5.3 Preparation of  cleaning Solution Lysol 2.5%v/v:

5.3.1 Take 250ml Lysol solution in a 10 liter SS container and make up to volume 10 liter.

5.3.2 Mix the solution with an SS rod.

5.3.3 Transfer in a suitable plastic container  and close the lid/cap  of the container.

5.3.4 Prepare the Lysol solution label affix on the container label.

5.4 Preparation of disinfectant solution Savlon 2.5%v/v:

5.4.1 Take 250ml Savlon solution in a 10 liter SS container and make up to volume 10 liter.

5.4.2 Mix the solution with an SS rod.

5.4.3 Transfer in a suitable plastic container  and close the lid/cap  of the container.

5.4.4 Prepare the Savlon solution label affix on the container label.

 5.5 Preparation of disinfectant solution Dettol 2.5%v/v:

 5.5.1 Take 250ml Dettol solution in a 10 liter SS container and make up to volume 10 liter.

5.5.2 Mix the solution with an SS rod.

5.5.3 Transfer in a suitable plastic container  and close the lid/cap  of the container.

5.5.4 Prepare the Dettol solution label affix on the container label.

5.6 Preparation of disinfectant solution Cetrimide 2.5%v/v:

5.6.1 Take 250ml Cetrimide solution in a 10 liter SS container and make up to volume 10 liter.

5.6.1 Mix the solution with an SS rod.

5.6.1 Transfer in a suitable plastic container  and close the lid/cap  of the container.

5.6.1 Prepare the Cetrimide solution label affix on the container label.

 5.7 Preparation of disinfectant solution BKC (Benzalkonium Chloride) 0.5%v/v:

5.7.1 Take 50ml BKC solution in a 10 liter SS container and make up to volume 10 liter.

5.7.2 Mix the solution with an SS rod.

5.7.3 Transfer in a suitable plastic container  and close the lid/cap  of the container.

5.7.4 Prepare the BKC solution label affix on the container label.

5.8  Preparation of disinfectant/sanitizer solution IPA 70%:

5.8.1 Take a 7 liter IPA solution in a 10 liter SS container and make up to volume 10 liter.

5.8.2   Mix the solution with an SS rod.

5.8.3 Transfer in a suitable plastic container  and close the lid/cap  of the container.

5.8.4. Prepare the 70% IPA solution label affix on the container label.

5.9 Frequency for preparation of cleaning and disinfectant solution:

5.9.1 Prepare Savlon 2.5%v/v /dettol 2.5%v/v /cetrimide 2.5%v/v solution alternate week to avoid   the microbial resistance. In absence of any one prepare BKC 0.5%v/v solution.

5.11 Precautions:

5.11.1 Use face mask, hand gloves, aprons, safety footwear etc  during Cleaning agents and disinfectants.

5.11.2 Use always freshly prepared dilutions of disinfectant solution.

5.11.3 Use within 24 hours after preparation of Disinfectant & discard the left over solution.

6. ATTACHMENTS/ANNEXURE

 

Annexure Title Format no.
Annexure-I Cleaning and disinfectant solution preparation logbook PD01.01.00

 

7. REFERENCES

NA

8. ABBREVATIONS

BKC:  Benzalkonium Chloride

PD: Production

QC: Quality Control

WH: Warehouse

9. DISTRIBUTION

Master copy   : QA

Control Copy: WH

Control Copy: QC

Control Copy: PD

10. REVISION SUMMARY

Supersedes Effective Date Reason for Review Remark
00 04/06/2020 New SOP Change control no. CCPD001

 

 

 

 

 

                                                               Annexure-I                                                          01 of 01

 

CLEANING AND DISINFECTANT SOLUTION PREPARATION LOGBOOK

Date/time Cleaning agent

(Teepol 1%v/v  / Lysol 2.5%v/v )

Disinfectant

(Savlon 2.5%v/v / Dettol 2.5%v/v / Cetrimide 2.5%v/v / BKC* 0.5%v/v)

Antiseptic

(IPA 70%)

In absence of any one prepare BKC 0.5%v/v solution.                                                  PD01.01.00

What is the importance of cleaning and sanitation?

To avoid the mix-up of previous residue/ traces and microbial contamination.

What is the example of cleaning and sanitation?

Cleaning agent: Teepol 1%v/v & Lysol 2.5%v/v. Sanitation : Savlon 2.5%v/v , Dettol 2.5%v/v , Cetrimide 2.5%v/v, BKC 0.5%v/v and IPA 70%v/v.

What is the difference between cleaning and sanitizing?

Cleaning : removal extraneous material from surfaces and objects. Sanitizing : destruction / removal pathogenic micro-oraganisms but not necessarily resistant spores and are usually applied on inanimate objects or living tissue.

How is disinfection solution prepared?

Preparation of disinfection solution (Savlon 2.5%v/v) Take 250ml Savlon solution in a 10 liter SS container and make up to volume 10 liter. Mix the solution with an SS rod. Transfer in a suitable plastic container and close the lid/cap of the container. Prepare the Savlon solution label affix on the container label.

What are disinfectant solutions?

Disinfectants are potent substances, which destroy pathogenic micro-oraganisms but not necessarily resistant spores and are usually applied on inanimate objects. eg. Savlon 2.5%v/v , Dettol 2.5%v/v , Cetrimide 2.5%v/v and BKC 0.5%v/v.

What is an example of disinfection?

Example of disinfection are Savlon 2.5%v/v , Dettol 2.5%v/v , Cetrimide 2.5%v/v and BKC 0.5%v/v.

 

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