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HMA MEDICAL LTD

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE

Title: Noise Level
Department: Quality Assurance Issued Date: 7th June , 2023
Mandatory Review Date: 6th June , 2025 Effective Date: 8th June , 2023
No.: HMA/QAD/SOP036-01 Supersede: HMA/QAD/SOP036-00

1.0 OBJECTIVE:
To design a SOP that describes the procedure for the operation sound level meter.

2.0 SCOPE:
This SOP is applicable to the operation of the sound level meter for Production Facility.

3.0 RESPONSIBILITY:
All Physicochemical unit in the Quality Control Department shall be responsible for the
implementation and compliance with the SOP.
Head/Designee/Scientist/Study Directors of the Laboratory shall be responsible to ensure
the
implementation and compliance with all SOP.

4.0 ABBREVIATION:
SOP Standard Operating LCD Liquid Crystal Display
Procedure
dB Decibel AHF Animal House Facility

5.0 DEFINITION:
A sound level meter is a hand-held device fitted with a microphone that allows you to
measure the sound pressure level and acoustic intensity.

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorized by General Manager

 Page 2 of 4
HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE

Title: Noise Level
Department: Quality Assurance Issued Date: 7th June , 2023
Mandatory Review Date: 6th June , 2025 Effective Date: 8th June , 2023
No.: HMA/QAD/SOP036-01 Supersede: HMA/QAD/SOP036-00

6.0 PROCEDURE:
6.1 The Sound Level Meter measures the sound of level in decibels. It can be used for activities
such as:
6.1.1 Environmental noise studies
6.1.2 Sound Level Comparisons
6.1.3 Investigating room acoustics
6.1.4 Sound isolation modeling
6.1.5 Sound propagation modeling
6.2 Operating Procedure
5.1.1 Slide the “Power ON/OFF/Hold switch” to the “1” position will power on the meter “1” =
Power ON “0” = Power OFF.
5.1.2 Determine the proper measuring range by selecting the “Range switch “to minimize the
tolerance of a readout when the left corner of the LCD shows:” “(Range upper/lower
indicator). It shows the dB range selection is upper or lower setting. Slide range switch to
other range for measuring.
5.1.3 Hold the instrument in hand and point the microphone at the measured noise source, the
sound level will be displayed on the “dB” (decibel) unit.
5.1.4 During the measurement, if slide the “Power ON/OFF/Hold switch” to the “Hold “position
will freeze the display value. If slide the “Power ON/OFF/Hold switch” to the “1” position.
Then the display will make the measurement continually.

5.2 Precautions/Ehs
Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorized by General Manager

 Page 3 of 4
HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE

Title: Noise Level
Department: Quality Assurance Issued Date: 7th June , 2023
Mandatory Review Date: 6th June , 2025 Effective Date: 8th June , 2023
No.: HMA/QAD/SOP036-01 Supersede: HMA/QAD/SOP036-00

5.2.1 All PPEs like an apron, gloves, mask, head caps, and show cover should be worn
before using the instrument.
5.2.2 Press Keys softly.
5.2.3 Clean the equipment with a dry piece of robe or a lightly moistened one, do not
use organic solutions.
5.2.4 Never use abrasive products or dissolvent.
5.2.5 Never pour water/liquid on the equipment.
5.2.6 When the left corner of the LCD displays shows “BAT”, it indicates a normal battery output
of less than 6.5 V-7.5 V. it is necessary to replace the battery. However, in-spec
measurement may still be made for several hours after the LOW BATTERY INDICATOR
appears before the instrument become inaccurate.

4.0 ANNEXURES:
Annexure I: Noise Level Test Result

5.0 FREQUENCY:
As at when required

6.0 DISTRIBUTION:
Master copy - Quality Assurance Manager
Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorized by General Manager

 Page 4 of 4
HMA MEDICAL LTD
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

STANDARD OPERATING PROCEDURE

Title: Noise Level
Department: Quality Assurance Issued Date: 7th June , 2023
Mandatory Review Date: 6th June , 2025 Effective Date: 8th June , 2023
No.: HMA/QAD/SOP036-01 Supersede: HMA/QAD/SOP036-00

Controlled copy – Quality Control Manager, General Manager

7.0 REFERENCE DOCUMENT:

Not Applicable

8.0 REVISION LOG:

Revision No. Effective Date Reason for Revision
01 August, 2023 Review of SOP Format

Function Name Designation Signature Date

Compiled by Quality Assurance Executive

Reviewed by Quality Control Manager

Approved by Quality Assurance Manager

Authorized by General Manager

 Annexure I
NOISE LEVEL TEST RESULT
(Ref: HMA/QAD/SOP036-01)

Test Date:
N Noise Index
o. Clean Room (dB) Remark
1. QC Physico-Chemical Lab

2.
Microbiology Incubation Room
3.
Microbiology Sterility Room A
4. Microbiology Sterility Room B

5. Air lock/Sterilization Room

6. Assembly Clean Room

7. Injection Molding Production Hall A

8. Injection Molding Production Hall B

9. Clean Area/ Air lock Buffer Room

10. Injection Moulding/Raw Material Buffer

Room
11.
Blister Packing Receiving Bay
12.
Needle Assembly Room A
13.
Needle Assembly Room B
14. Crushing

Standar
≤ 65dB
d
Conclusi
on

Done by: Checked by: Approved by:

Sign/Date: Sign/Date: Sign/Date:

Designation: Designation: Designation:

E-mail: hmamedicalltd@gmail.com
 Annexure I
NOISE LEVEL TEST RESULT
(Ref: HMA/QAD/SOP036-01)

E-mail: hmamedicalltd@gmail.com