Standard Operating Procedure for Operation, Cleaning and Maintenance of Dynamic Pass Box use in pharma industry.
Objective
To lay down a procedure for operation, cleaning and maintenance of dynamic pass box.Scope
This SOP shall be applicable to Production department for operation, cleaning and maintenance of dynamic pass box. The other concerned departments are QA, Housekeeping and Engineering.
Responsibility
Operator Production shall be responsible to perform operation of dynamic pass box.
Housekeeping Personnel shall be responsible to perform the cleaning of dynamic pass box under the supervision of Officer Production.
Officer/Executive/Sr. Executive Production shall be responsible to check that correct procedure followed during operation, cleaning and maintenance of dynamic pass box.Officer/Executive/Sr. Executive QA shall be responsible to verify that correct procedure is being followed during operation, cleaning and maintenance of dynamic pass box.
Officer/above Engineering person shall be responsible to perform the Preventive maintenance and maintenance of dynamic pass box.
Accountability
Head Production and Head QA shall be accountable for the compliance of this SOP.
Procedure:
General Conditions and Precautions
Dynamic Pass Box is being used for transfer of material through controlled environment without personnel movement. It also aid to control ingress of particulate contaminants in to clean room and different classified area.Dynamic pass box is equipped with interlocking system that prevents both the doors being opened at same time. If the doors shall not be closed properly, then the auto-visual alarm system shall be activated automatically.
Wear PPEs kit during operation and cleaning of Dynamic Pass Box.
Magnehelic Gauge is provided in respective pass box to check and record the Differential Pressure across the HEPA filter.
Always check the Differential Pressure reading on gauge before use.
Total burning hour of UV light shall not be greater than 8000 hours and after that UV light shall be replaced with new UV light.
Description of Dynamic pass box
Dynamic Pass Box is equipped with interlocking system that prevents both the doors from being opened at the same time
Swing type doors with view panels are provided in pass box.- Motor blower status indicator is provided on pass box to indicate the ‘ON’ and ‘OFF’ status of pass box.
Separate switches are provided for UV, alarm and blower, if not necessary can be switched OFF.
UV light hour meter is provided to indicate the burning time of UV light.
Magnehelic Gauge is provided to indicate Differential Pressure.
Fluorescent white light is provided for lighting purpose inside pass box.
UV light is interlocked with door and tube light i.e. it will turn ‘OFF’ in case doors are opened and it turns ‘ON’ when both doors are closed.
Tube light is interlocked with door and UV light i.e. it will turn ‘OFF’ in case of both doors is closed and it turns ‘ON’ when door opened.
Motor blower and UV light should continuously switch ‘ON’ while material is in pass box.Operation Procedure:
- Switch ON the main power supply of Dynamic Pass Box.
Switch ON the UV light and blower 20 min. before starting the work.To open the door gently, turn the round handle to right, and to close press the door smoothly inside so that the door will be locked.
When the door is opened the UV light will get switch OFF.
Open the door and transfer the material from one side of pass box and close the door.
Keep the material in the pass box and wait for 2 minutes for stabilizing the pass box.
Record the burning hour for UV lamp and replace it after 8000 hours.
Switch off the motor blower and UV light after use.
Record the operation starting and ending time detail in equipment log book.
Monitoring of Differential Pressure shall be done in start of shift and before use.
UV burning time recording from hour meter shall be done at start of day.
Cleaning Procedure:
Frequency: At the Start of the shift and cleaning after transfer of material for one product to another product through the dynamic pass box.
Cleaning :Use lint free cloth and purified water for cleaning of pass box.
Clean internal and external surface of pass box with wet lint free cloth dipped in purified water.
Finally dry internal and external surface of pass box with dry lint free cloth.
Sanitize the internal and external surface of pass box by using 70% V/V Iso Propyl Alcohol solution.
Record the Cleaning starting and ending time detail in equipment log book.
Maintenance:
Preventive Maintenance of pass box shall be performed as per Engineering Preventive Maintenance SOP.
Maintenance work to be done as when ever required.
If any maintenance work is required to be done, raise maintenance work order.
Record maintenance details of Dynamic Pass Box in Equipment Logbook.
End of the SOP.
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