Tuesday , September 26 2023

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

INDEX

PART –I                                                                                                 Page no.

Objective

Brief Description

Purpose

Procedure

Acceptance criteria

PART –II

Data generation for viable count

PART –III

Summary

Recommendation

Attachments

PART-I 

1.0          OBJECTIVE

The objective of this study is to determine the efficacy of  UV germicidal lamp of Laminar air flow and pass box with known microorganism. This ensure that the UV is effective enough to kill the microorganisms on exposure to defined period of time and gives the idea at when the UV light to be replaced.

2.0          BRIEF DESCRIPTION

The purpose of UV lamp used in Laminar air flow and pass box are for germicide activity of that environment.  It is important to ensure that the germicidal effectiveness of UV lamp at given time during the test should produce reproducible result.

The study shall be conducted with 200 to 250 microorganisms per plate. These plates shall be exposed to UV lamp at defined places on the working platform (figure 1) for the given time intervals.

 

 3.0          PURPOSE

The purpose of UV lamp used in Laminar air flow and pass box are for germicide activity of that environment. This shall be achieved by exposing plates containing viable microorganisms for different time intervals. 

  • PROCEDURE 
  • PREPERATION 
  • Prepare cell suspension of Bacillus subtilis containing approximately 1000 cells / ml.
  • Prepare Soyabean casein digest agar plates as per STP .
  • Using sterile glass spreader, spread 0.25 ml of cell suspension on the surface of Soyabean casein digest agar plates.
  • Expose these plates under UV lamp as shown in fig.1 for defined time interval.
  • After exposure, cover the plates with lid and incubate at 37°C for 3 days.
  • Repeat the test for each time interval.
  • Keep one un-inoculated plate as negative control and one plate, which is inoculated but not, exposed to UV, as positive control.
  • From positive control evaluate No. of colony forming units as “Initial count”.
  • Count the No. of colony forming units for each exposed plate.
  • Calculate reduction in count after UV exposure.

6.0       ACCEPTANCE CRITERIA 

There should be 99 % reduction in the viable count after UV exposure for 30 minutes.

PART-II 

DATA GENERATION  

            Initial count :

Sr. No. Exposure time Location of

Plate

Viable count % reduction
1. 1 Minute Rear – Left
  Rear – Right
  Front – Left
  Front – Right
  Center
2. 2 Minutes Rear – Left
  Rear – Right
  Front – Left
  Front – Right
  Center
3. 5 Minutes Rear – Left
  Rear – Right
  Front – Left
  Front – Right
  Center
4. 10 Minutes Rear – Left
  Rear – Right
  Front – Left
  Front – Right
  Center
5. 15 Minutes Rear – Left
  Rear – Right
  Front – Left
  Front – Right
  Center
6. 30 Minutes Rear – Left
  Rear – Right
  Front – Left
  Front – Right
  Center

 PART-III

SUMMARY

RECOMMENDATION

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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