Few facts about Dynamic Pass Box
Through this blog we will be providing you the qualification and routine maintenance of dynamic pass boxes in your critical and non critical area. As per the industrial practices some time we do more than the requirement and that create an additional burden for us. Rather than doing extra we should adopt some scientific rationale to define the risk level in our facility. Doing correct things in right time gives us the assurance of better compliance. I will suggest don’t think about the compliance all time, we should confirmed our procedure are made based upon robust scientific background.
Now we will be coming to fact. Dynamic pass box nothing but consider as air lock. It is provide a physical barrier in between different between or in between same grade. Normally dynamic pass box installed in the clean rooms as per follow pattern,
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Uncontrolled
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Controlled but unclassified
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Grade D
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Grade C
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Grade B
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Uncontrolled
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Accepted
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Accepted
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Not recommended
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X
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X
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Controlled but unclassified
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Accepted
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Accepted
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Accepted
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Not recommended
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X
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Grade D
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Not recommended
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Accepted
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Accepted
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Not recommended
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Grade C
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X
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X
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Not recommended
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Accepted
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Not recommended
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Grade B
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X
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X
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X
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Not recommended
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Accepted
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Requirements Vs risk level
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Availability (in between )
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Requirements
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Risk Level
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Uncontrolled to uncontrolled
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Transfer input material or dirty material movement (e. g Scrap)
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Low
Recommended to installed static pass box
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Uncontrolled to control but unclassified
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Transfer input material or dirty material movement (e. g Scrap)
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Low
Recommended to installed static pass box
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Control but unclassified to Grade D
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Transfer input material or dirty material movement (e. g Scrap)
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Low
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Uncontrolled to Grade D
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Transfer input material or dir
ty material movement (e.g. used garments, face mask & gloves ) |
Medium
Chance for cross contaminations or breached area cleanliness in case of sudden break down of equipment
All material in Grade B should to be transfer after steam sterilization and should unload from steam sterilizer under LAF.
Power fail can cause significant impact on the area where the pass box has been installed, so it is recommended to keep dynamic pass box under uninterrupted power supply.
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Control but unclassified to Grade C
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Grade D to Grade C
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Grade C to Grade B
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Control but unclassified to control but unclassified
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Transfer input material or dirty material movement (e. g Scrap)
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Low
Recommended to installed static pass box
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Grade D to grade D
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Movement of dispensed API or Excipients material
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Low
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Recommendations for Qualification and routine controls
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Test Sr. No
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Qualification Test
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Qualification frequency in a year
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SOP control
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Grade A & B
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Grade C & D
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1
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Air velocity
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Twice
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Once
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Not available
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2
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Non viable particle count
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Twice
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Once
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As per area test frequency
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3
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Microbial monitoring
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Once
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Once
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As per area test frequency
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4
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ΔP
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Once
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Once
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At least once daily
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5
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Filter integrity
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Twice
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Once
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Not available
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6
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*Airflow visualization
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Initially
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Initially
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Not available
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Note: *Airflow visualization should be repeated once any major changed done in the system. (e.g. filter change /repair), In case of Grade B it can be repeated once in a 2 year as a precautionary measure and it is recommended to installed Grade b to grade B , not preferred to installed between Grade B to Grade C/D.
Requirements of performing airflow visualization in Pass box
1. To check the laminarity
2. Air should be flowing smoothly in one direction with no turbulence or eddies
3. When doors are opened within areas, air flow is disturbed and becomes turbulent as it sweeps through the air stream when opening. Smoke studies should capture the effects of the disturbance and document the air recovery to smooth unidirectional air flow.
Additional inputs,
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Do you know
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Why
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Reasons
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Front of pass box consider at which side the Makeup filter grills is places
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Not Applicable
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Trick to identify pass box direction , as both side looks similar
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Pass box takes supply air from the adjoined clean area
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It will enhance the filter life
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Higher grade/clean zone having more clean air
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It is a barrier in between same grade or intra grade clean room area
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It don’t allow to passed air in between adjoined area
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It act as Airlock (Bubble /shrink)
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If you open both door together then also ΔP will maintained , it will not be zero
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As it is act as airlock
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Its having variable frequency drive (VFD) in the motor , that maintains desired pressure difference
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Pass box area cleanliness should to be meet the requirement of adjoin higher grade area
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Otherwise chance of cross contamination increases
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Particularly when pass box installed between different Grades (e.g. Grade B to grade C)
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Viable and non viable should to be performed as per area classification requirements, don’t consider pass box is separate entity from your area.
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As it is a part of your area it should consider as same (or higher) classification with respective to area
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Not applicable
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What grade you should considered for installed pass box for viable and non viable monitoring.
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As per the higher classification of the area (if installed between Grade C to Grade D , pass box shall be consider as Grade C)
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It minimizes the area contamination risk
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You should pass box under UPS connectivity /& don’t switch off (Caution: Directly connect with power supply don’t put ON/OFF switch )
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Power Failure /switch off will caused risk to your clean rooms due to cross contaminations
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Established power failure recovery periods if UPS not available.
Don’t operate during power fails
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Leakage from the pass box door gasket should immediately arrest
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Efficiency of motor will reduce
In long run
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Not applicable
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Viable test limits as per Regulatory Guidance recommendations:
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Grade
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Air sample (CFU/m3)
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Settle plates (90mm diameter) (CFU/4hours)
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Contact plates (55mm diameter) (CFU/plate)
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Glove print (5 fingers) (CFU/glove)
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A
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< 3
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< 3
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< 3
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< 3
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B
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10
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5
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5
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5
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C
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100
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50
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25
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–
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D
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200
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100
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50
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–
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This Dynamic Pass Box to me is a precisely manufactured box that has some specifications while moving different products stored inside it. It is used in different industries containing deliquate and high-tech products.
This Dynamic Pass Box to me is a precisely manufactured box that has some specifications while moving different products stored inside it. It is used in different industries containing deliquate and high-tech products.
What shall be Velocity limit for Dynamic pass box?
What shall be Velocity limit for Dynamic pass box?