UV LIGHT EFFICIENCY TEST

1.0 OBJECTIVE:

This SOP describes the procedure for UV light efficiency test.

2.0 SCOPE:

This procedure is applicable for UV light efficiency test .

3.0 RESPONSIBILITY:

        Microbiologist

4.0 ACCOUNTABILITY:

QC Manager.

 5.0 PROCEDURE:

5.1 Equipment Required:

  • LAF

5.2 Material Required:

  • 70% IPA solution
  • Pre-incubated SCDA plates

5.3 Methodology:

  • Prepare SCDA medium as per SOP for preparation of culture media.
  • Aseptically pour approximately 15 – 20 ml of sterile molten cooled (40 – 45°C) SCDA agar into sterile 90 mm Petri plates under LAF.
  • Allow the media to solidify the plates under LAF, after solidification labels all the plates with name of media, preparation batch no. and date of preparation.
  • Invert and incubate the plates at 30 to 35°C for 24 hrs in BOD Incubator. After incubation physically inspect the plates for any contamination (Microscopic growth of evidence), if there is contamination discard the plates as per SOP for Destruction of Microbial waste by Autoclaving.
  • After pre-incubation, transfer 1-1ml of not less than 105 cfu per ml culture of E.coli to two SCDA Petri plates & spread the colony using sterile spreader.  (Prepare 106 E.coli cfu per ml suspension).
  • Now wrap one petri plate containing E.coli in aluminum foil and do not wrap other petri plate.  Now transfer both the petri plates in LAF.  Open the lid of unwrapped petri plate.
  • Now switch on UV light for 30 minutes.
  • After 30 minutes exposure, switch off the UV light & close the lid of unwrapped petri plate.
  • Incubate both the petri plates in incubator at 30-35°C for 24-48 hours.
  • Prepare positive control by streaking E.coli culture and negative control as it is without streaking.
  • Apply the same procedure for UV Light of other LAF & Pass Box.  For checking efficiency of UV Light of LAF of Sterility Room, do not perform the test in Sterility room.  For the test, the UV light of sterility LAF should be fitted to MLT or Bioassay LAF.
  • After incubation observe the plates for total bacterial count. Record the results more than 90% of the bacterial should be killed in the exposed plate.

5.4 Precautions :-

  • Switch on the UV light after exposing the plates on the work station of the LAF.
  • Switch off the UV light before collecting the plates.

5.5 Frequencies:

  • Once in six month.

6.0 TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the microbiology departments

7.0 DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           Microbiology Department

Display Copy                 :           Microbiology Department (If Required)

8.0 ATTACHMENTS:

Sr. No. Title
01. Record of UV Light Efficiency Test
02. UV Light Burning Record

9.0 REFERENCES:

In-House

10.0 ABBREVIATIONS:

Abbreviations Extended Form
SOP Standard Operating Procedure
NA Not Applicable
MB Microbiology
Sr. No. Serial Number
QA Quality Assurance
DEPT. Department
IPA Isopropyl Alcohol
% Percentage

11.0 REVISION HISTORY OF CHANGE:

Sr. No. Date Revision Details Revision No.
01 …… NEW SOP 00

UV Visible Spectroscopy

SOP For Calibration of UV-Visible Spectrophotometer

Beer lambert law

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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