LAMINAR AIR FLOW

1. PURPOSE

1.1 It is established to provide a proper procedure for maintaining the positive sterile air pressure in the sterile area.

2. SCOPE

2.1 It is applicable in the Injectables and Quality Control department.

3. RESPONSIBILITY

3.1 Maintenance officer (Mechanical / Electrical)
3.2 Maintenance Supervisor (Mechanical / Electrical)

4. PROCEDURE

The Laminar Flow with instrument is handled in the following way.


5. MAINTENANCE

MONITORING OF MACHINE MAINTENANCE:

Time to time check each and every part of Laminar Air Flow according to the maintenance schedule.
Check the following parts carefully.
 Electric motor
 Electric Starter
 Blowers
 Shaft & Bearings
 Clean the Pre-Filter
 Hepa Filter (replace the filter if chocked)

This activity is then documented in the form Machinery & Equipment Maintenance Log
Check the Laminar Air Flow condition time to time to find any kind of problem during operation.
All the monitoring record is filed and kept by the Maintenance Supervisor.

EMERGENCY / BREAKDOWN MONITORING:

Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.
Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register.
Maintenance Manager assigns the maintenance work to the concerned personal
After the completion of work the section incharge signs the completion of Work Order.
All the record is filed and kept by the Maintenance Supervisor.

PRECAUTION:

The trained operator should handle the machine.