OBJECTIVE:
To lay down a Procedure for Codification of Grill, Filter and Lights in Pharmaceutical.
SCOPE:
This SOP is applicable for codification of the grill, filter, and lights in pharmaceuticals at {Company Name} {Location}.
RESPONSIBILITY:
Technician- Follow the instruction as per procedure.
Engineering Officer/Executive—Execution as per laid-down procedure.
Engineering Head—Technical correction, review, training & monitoring of SOP.
ACCOUNTABILITY:
Engineering Head
Quality Assurance Head
PROCEDURE:
Codification of Filter and Grill:
Engineering officer/Executive shall prepares a master list for different types of filters used in different type of equipments like Depositor machine, Pillow packing machine, Air handling unit, Reverse Laminar air flow, Laminar air flow unit, dynamic pass box in the plant in different area like Utility, Warehouse, Quality control and Production.
A unique code shall be allotted to each filter depending upon the type of filter, size of the filter, location of the filter.
Following procedure to be followed to allot codification for all filters to be fixed in the equipments.
UT/CCC/DDD/EE/FF-GG
Where the following are stands for;
UT- Stand for Utility.
CCC- Indicate the equipment short forms like AHU- Air Handling Unit, LAF- Laminar Air Flow unit, DPB- Dynamic Pass Box, And ACR- Air Compressor.
DDD- Indicate the equipment Number like 001, 002, 003……
EE- Indicate the Filter Type like PF-Pre filter, FF-Fine Filter, HF- HEPA Filter, CF-Cartridge Filter.
FF- Indicate the Quantity of filters like 01, 02, 03…..
GG -Replaced filter like if the filter replaced so many times 01, 02, 03….. And if the filter install first time then would be there 00.
Example: In the case of pre-filter of AHU in manufacturing area the filter serial number shall be
Assigned as UT/AHU/001/PF/01-00, if another pre-filter is installing in AHU then filter I.D assigned as UT/AHU/001/PF/02-00.
Example: In the case of any type of filter of AHU replace with new one then filter I.D Assigned as UT/AHU/001/PF/01-01and for another filter I.D Assigned as UT/AHU/001/PF/02-01.
Example: In the case of fine-filter of AHU in manufacturing area the filter serial number shall be
Assigned as UT/AHU/001/FF/01-00.
Example: In the case of HEPA-filter of AHU in manufacturing area the filter serial number shall be
Assigned as UT/AHU/001/HF/01-00.
The following procedure to be followed for the Grills installed in the room supply and return riser filter.
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UT/CCC/DDD/EE/FF
Where the following are stands for;
UT- Stand for Utility.
CCC-Indicate the equipment short forms like AHU- Air Handling Unit.
DDD- Indicate the equipment number like 001, 002, 003…..
EE- Indicate the grill short forms of SA for Supply Air, RA for Return Air, and EA for Exhaust Air.
FF- Indicate the grill no. like 01, 02, 03….
Example: In the case of supply air in room of air handling unit in manufacturing area the grill serial
Number shall be assigned as UT/AHU/001/SA/01.
Example: In the case of return air in room of air handling unit in manufacturing area the grill serial number shall be assigned as UT/AHU/001/RA/01.
In case AHU Pre-filter ID no. PF/01, 02 & 03 shall be allotted in increasing order (UT/AHU/001/PF/01), (UT/AHU/001/PF/02), (UT/AHU/001/PF/03) and AHU HEPA filter supply grill ID no.SA/01, 02, 03 shall be allotted in increasing order (UT/AHU/001/SA/01), (UT/AHU/001/SA/02), (UT/AHU/001/SA/03).
Update the filter master list as per Annexure-I.
Update the Supply Air, Return Air and Exhaust Air Grill Master List as per Annexure-III.
If any new filter add in between the calendar year engineering officer/ executive shall prepared the additional filter master list as per Annexure-II.
If any new Supply Air, Return Air and Exhaust Air Grill add in between the calendar year engineering officer/executive shall prepared the additional Supply Air, Return Air and Exhaust Air Grill master list as per Annexure-IV.
All additional lists shall be merging in a common master list at the end of calendar year.
Codification of Light:
Engineering officer/executive shall inspect the entire light fixtures which are installed in the plant.
The total light fixtures shall be listed and a master list for light fixtures shall prepared by the engineering officer/executive.
Engineering officer/executive shall allot a unique code for each light fixture depending on the type o the light fixture.
The lights fixtures shall be coded with respective to different type of light.
Following procedure has to be followed to give codification for all plant Lights.
PGH/AA/BBB/CC-DD
Where the following are stands for;
PGH- Stand for, {Company Name}
AA- Indicate the department name (PD, QA, QC, UT, WH, AD and SC).
BBB- Light fixture type like LED- Light emitting diode.
CC- Light fixture serial number like 01, 02, 03………………
DD- Replaced light like if the light replaced so many times 01, 02, 03…….
Example: In the case of Light emmitting diode light in production area. The light fixture serial number shall be assigned as PGH/PD/LED/01-00.
Update the light master list as per Annexure-V.
If light emitting diode (LED) light in production area shall be replaced first time then the light I.D assigned as PGH/PD/LED/01-01.
REFERENCES:
Not Applicable
ANNEXURES:
| ANNEXURE No. | TITLE OF ANNEXURE |
| Annexure-I | Filter Master List |
| Annexure-II | Additional Filter Master List |
| Annexure-III | Supply Air, Return Air and Exhaust Air Grill Master List |
| Annexure-IV | Additional Supply Air, Return Air and Exhaust Air Grill Master List |
| Annexure-V | Light Master List |
ENCLOSURES: SOP Training Record
DISTRIBUTION:
Controlled Copy No. 1 Quality Assurance Head
Controlled Copy No. 2 Engineering Head
Master Copy Quality Assurance Department
ABBREVIATIONS:
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
AHU : Air Handling Unit
LAF : Laminar Air Flow
DPB : Dynamic Pass Box
HEPA : High Efficiency Particulate Air
I.D : Identification
VCC : Vacuum cleaner
HM : Hygrometer
MG : Magnehelic gauge
PGH : Pharmaguidehub
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
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ANNEXURE-I
MASTER LIST OF FILTERS
ANNEXURE-II
MASTER LIST OF ADDITIONAL FILTER
ANNEXURE-III
ANNEXURE-IV
MASTER LIST OF ADDITIONAL SUPPLY AIR, RETURN AIR AND EXHAUST AIR GRILL
ANNEXURE-V
MASTER LIST OF LIGHT
ANNEXURE-V
MASTER LIST OF LIGHT
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