1.0 Objective
To lay down a procedure of operation of the Lux meter and monitoring the lux level.
2.0 Scope
This standard operating procedure is applicable for monitor the lux levels in production areas, sampling and dispensing booth by using lux meter at pharmaceutical formulation plant.
3.0 Responsibility
Engineering officer / Technician or above in engineering shall be responsible for monitoring the lux levels.
Head of maintenance departments shall be responsible for maintenance of records of lux levels.
Accountability
Engineering Head & Head QA shall be accountable for the implementation of this SOP.
Abbreviations and Definitions
SOP : Standard Operating Procedure;
QA : Quality Assurance
Ltd. : Limited
6.0 Procedure
6.1 Operation of lux meter
6.1.1 Switch “ON” the lux meter.
6.1.2 Ensure initial reading should be zero, otherwise adjust the zero by using zero off set.
6.1.3 Range A: Measures 0 to 1999 lux resolution 1
Range B: Measures 2000 to 19990 lux resolution 10.
Range C: Measures 20000 to 500000 lux resolution 100.
6.1.4 Slide the switch as per the requirement (A, B or C).
6.1.5 Hold the light sensor facing towards light.
6.1.6 The display will show lux level.
6.1.7 The multiplication of displayed value with multiplying factor will be actual lux.
6.2 Monitoring of lux level:
6.2.1 Hold the lux meter at minimum 5 location.
6.2.2 Measure the lux at 1 meter height from ground level.
6.2.3 Record the reading in lux level monitoring record. (Annexure-I)
6.2.4 The average lux of all readings will be lux level in room.
6.3 Acceptance criteria:
6.3.1 The lux level measured shall not be less than
400 lux for production areas
300 lux for sampling and dispensing booths.
6.3.2 Frequency for monitoring the lux level is once in a year.
7.0 Forms and Records (Annexures)
Lux level monitoring record – Annexure-I
8.0 Distribution
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production, Warehouse and Engineering
10.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Lux level monitoring Record
Lux Meter ID No. Area: Date:
| S. No. | Location Name | Observed reading From Locations | Average reading | Checked by | Verified by (QA) | ||||
| L1 | L2 | L3 | L4 | L5 | |||||
Frequency: Once in a year
