sop for validation protocol for UV light efficacy of Dynamic Pass Box and Laminar Air Flow

S. No.	TITLE	PAGE No.
1.0	PROTOCOL APPROVAL
2.0	OBJECTIVE
3.0	SCOPE
4.0	RESPONSIBILITY
5.0	METHODOLOGY
6.0	ACCEPTANCE CRITERIA
7.0	RECORDING
8.0	ABBREVIATIONS
9.0	REFERENCE
10.0	REVISION HISTORY

1.0 PROTOCOL APPROVAL

PREPARED BY:

DESIGNATION

NAME

SIGNATURE

DATE

OFFICER/EXECUTIVE

(QC MICROBIOLOGY)

REVIEWED BY:

DESIGNATION	NAME	SIGNATURE	DATE
EXECUTIVE/MANAGER (QC MICROBIOLOGY)
HEAD (PRODUCTION)
HEAD (ENGINEERING)
HEAD (QUALITY CONTROL)

APPROVED BY:

DESIGNATION

NAME

SIGNATURE

DATE

HEAD

(QUALITY ASSURANCE)

2.0 OBJECTIVE

U.V Light mainly damages the DNA of the cell at the adjacent lesions at the time of replication.
Error base pairs known as error prone interferes during the replication so mutagenesis occurs,
This procedure is also known as SOS system. Due to this reason DNA replication is not
perfectly
Completed and it leads to death of the cell.

3.0 SCOPE

The protocol covers all aspects of Qualification of UV Light radiation (used in the DPB & LAF) in the Production and Microbiology lab at ABC Company
The protocol is applicable for checking the Bactericidal and Fungicidal Efficacy of UV light radiation

4.0 RESPONSIBILITY

DEPARTMENTS	RESPONSIBILITIES
Quality Control	· To Prepare, Review and Approval of Protocol · Protocol Training · To provide all applicable analytical procedures and documentation necessary for execution of this protocol. · To test the sample collected and provide all Analytical Data.
Production	· To review of protocol
Quality Assurance	· To monitor all validation activities and ensuring the validation as per the protocol. · To monitor protocol completeness and technical accuracy · To review and approve the validated procedure.

5.0 METHODOLOGY

5.0 Prepare the culture suspension of bacillus subtitles as per SOP No.
5.1 Prepare SCDA medium as per the SOP No:
5.2 Aseptically pour approximately 15-20 ml of sterile molten cooled (40-450C) SCDA agar into
sterile 90 mm Petri plates under LAF.
5.3 Allow the media to solidify the plates under LAF, after solidification marks all the plates with
the name of media.
5.4 Pre incubate the plates in inverted position at 30-350C for 48 hrs.
5.5 After completion of pre incubation visually inspect the plates for any contamination, if there is
contamination discard the plates as per SOP No.
5.6 After completion pre incubation transfer 1–1 ml of 10-100 cfu/ml culture of Bacillus subtitles to Six
SCDA Petri plates & spread the suspension using a sterile spreader.
5.7 Now wrap three Petri plate containing Bacillus subtitles in aluminum foil and do not wrap other three Petri plate.
5.8 Prepare positive control by streaking Bacillus subtilis culture and negative control as it is without streaking
5.9 Transfer the Petri plates to test location and open the lid of unwrapped Petri plate & not open the lid of wrapped Petri plates and switch on the UV light and collect the plate at the following intervals,05 minutes exposure, 10 minutes exposure and 15 minutes exposure.
5.10 After exposure switch off the UV light & close the lid of exposed Petri plate.
5.11 Incubate the plates at 30-35 C for 48 hrs.
5.12 After incubation observe the plates for the total bacterial count. Record the result on UV light
efficiency test record.
5.13 Frequency
5.13.1 Whenever new U.V light installed.

6.0 ACCEPTANCE CRITERIA

6.1 There should not be growth in unwrapped petri plate and there should be growth in Petri
Plates wrapped in aluminum foil. Positive control should show growth and negative control
Should not show any growth.

7.0 RECORDING

After completion of each study, a report shall be prepared which shall include the following information.
6.1 Tabulated Data
6.2 Conclusions

8.0 ABBREVIATIONS
MLT Microbial Limit Test
LAF Laminar Air Flow
SCDA Soyabean casein digest Agar
UV Ultra Violet
DPB Dynamic Pass Box