OBJECTIVE:
To lay down a Procedure for Preventive Maintenance of RLAF & LAF.
SCOPE:
This SOP is applicable for Preventive Maintenance of RLAF & LAF 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
ABOUT RLAF AND LAF:
RLAF (Reverse Laminar Air Flow) and LAF (Laminar Air Flow) are both critical air handling systems in the pharmaceutical industry, designed to maintain sterile environments. However, their primary difference lies in the direction of airflow. RLAF directs air from potentially contaminated areas towards cleaner ones, providing operator and product protection, crucial during powder handling like sampling and dispensing. This inward airflow captures airborne particles and prevents their spread to cleaner zones.
In contrast, LAF systems direct filtered air unidirectionally from a clean area towards a potentially less clean one, primarily focusing on product protection from environmental contaminants. LAF is commonly used in aseptic processing and filling operations. While both utilize HEPA filters to ensure high air quality, RLAF’s reversed airflow is specifically tailored for containment and operator safety when handling hazardous materials, whereas LAF focuses on maintaining a sterile field for product integrity.
PROCEDURE:
Precautions and general conditions:
Switch off the power supply before starting the Preventive Maintenance.
Put status board as ‘UNDER PREVENTIVE MAINTENANCE’ on Equipment.
Refer the Master plan of Preventive Maintenance.
Equipment shall be available for Preventive Maintenance.
Clean oil / grease stains & remove unwanted material, spares after completion of work.
Use necessary safety wears, like gloves, goggles, safety shoe and nose mask if required.
Ensure covers & guards are properly fixed.
Preventive Maintenance frequency of RLAF & LAF as per the master Preventive Maintenance Schedule.
Engineering officer/executive shall provide the Preventive Maintenance checklist to engineering technician.
Do the Preventive Maintenance as per checklist / record and update the Preventive Maintenance status.
After completion of work, take the trial for checking smooth operation.
Quarterly Preventive Maintenance of LAF:
Check for abnormal sound from the motors, if required lubricates the motor bearings with castrol40 or equivalent grease.
Check the motor terminals, contacts of contactor and relays, if required clean with CTC.
Check the air leakages from the perforated grill of HEPA housing, if required tighten the filter housing bolts.
Check the HEPA filter condition, if found any damage replace it with new one.
Check the condition of tube light, if required replaces the tube light with new one.
Check the PVC curtain for any damage and proper fixing.
Check availability of power supply in the provided electric sockets of the LAF.
Clean the blower area.
Do the preventive maintenance of LAF as per Annexure-I.
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Quarterly Preventive Maintenance of RLAF :
Check for abnormal sound from the motors, if required lubricates the motor bearings with castrol40 or equivalent grease.
Check the motor terminals, contacts of contactor and relays, if required clean with CTC.
Check the air leakage from grill of pre-filter, if requires tightens the filter housing.
Check the pre-filter condition, if found damage replaces it with new one.
Check the air leakages from the perforated grill of HEPA housing, if required tighten the filter housing bolts.
Check the HEPA filter condition, if found any damage replace it with new one.
Check the condition of tube light, if required replaces the tube light with new one.
Check the PVC curtain for any damage and proper fixing.
Check availability of power supply in the provided electric sockets of the LAF.
Clean the blower area.
Do the preventive maintenance of RLAF as per Annexure-II.
Checked by (Reviewed by) sign. in the checklist shall be done on next day by reviewing if the preventive maintenance to be done in the night shift.
REFERENCES:
Not Applicable
ANNEXURES:
| ANNEXURE No. | TITLE OF ANNEXURE |
| Annexure-I | Quarterly Preventive Maintenance Check list of LAF |
| Annexure-II | Quarterly Preventive Maintenance Check list of RLAF |
ENCLOSURES: SOP Training Record
DISTRIBUTION:
Master Copy Quality Assurance Department
Controlled Copy No. 01 Quality Assurance Head
Controlled Copy No. 02 Engineering Head
ABBREVIATIONS:
| SOP | : | Standard Operating Procedure |
| QA | : | Quality Assurance |
| HEPA | : | High Efficiency Particulate Air |
| CTC | : | Carbon Tetra Chloride |
| PVC | : | Poly Vinyl Chloride |
| LAF | : | Laminar Air Flow Unit |
| RLAF | : | Reverse Laminar Air Flow |
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
Quarterly Preventive Maintenance Check List of Laminar Air Flow
ANNEXURE-II
Quarterly Preventive Maintenance Check List of Reverse Laminar Air Flow
Click the link to download word file copy of this document:
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