Pass box:-
Introduction:-
Passbox is a type of equipment/instrument which is used for movement of material from two different zone /class /grade of Area to control the cross-contamination.
Type of Pass Box:
A. Statitic PassBox
B. Dynamic Pass Box.
A. Static Pass Box :- This is a type of Simple Passbox , which is used for movement of material from same Zone/Class/Grade of Area, it is work as barrier to prevent contamination from out source to clean Area. Passbox should be consist of Stainless Steel 304/316
B. Dynamic Pass Box:- Dynamic pass box is a device, which is used to transfer the material from area of one class to area of another class. DPB is having HEPA filter which creates and maintain grade A in the pass box. It is used to maintain the laminarity of the air
OPeration/Cleaning/Qualification of Dynamic Pass box:-
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OBJECTIVE
- To lay down the procedure for operation and cleaning of Static Pass Box And Dynamic Pass Box.
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SCOPE
- This SOP shall be applicable to operation and cleaning of Static Pass Box and Dynamic Pass Box installed in microbiology department.
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RESPONSIBILITY
- Microbiology Personnel shall be responsible for carrying out the operation and cleaning of Static Pass Box and Dynamic Pass Box.
- Officer Microbiology or above who is trained or well versed with the procedure shall be responsible for ensuring that the same is carried out correctly and checking of documents for completeness of content.
- Head Microbiology/ Designee shall be responsible for ensuring the compliance of the SOP.
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ACCOUNTABILITY
-
- Head Microbiology/ Designee shall be accountable for the proper implementation of the SOP.
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-
PROCEDURE:-
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Precautions:
- Ensure that the main power supply is connected to the equipment by checking the red color LED. It should glow red.
- Ensure that the blower is always in running condition (in case of DPB). If it is in OFF condition, then start the blower by pressing SS push button on top of DPB.
- Ensure that pressure displayed by magnehelic gauge is between 05-15 mm of WC for all DPB’s and record the DP as per Annexure-III.
- Frequency: Record the DP ones daily.
-
Note: If pressure is not in the specified limit then do not start the work and inform the Engineering Department through Breakdown intimation memo for rectification.
-
-
- Ensure that both the doors are closed and UV light is in ON condition.
- Only one door shall be opened at a time for any DPB.
- Do not open the door of any pass box forcefully.
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-
-
Operation:
- Pass boxes are provided with door interlock. When both the doors of pass box are closed red light will glow.
- To open the DPB, push inter locking button and then open the door.
- The UV light would be turned OFF and fluorescent light will be switched ON. Keep the material inside and close the door. Ensure that UV light has switched ON.
-
Note: In case of DPB, while transferring material from lower grade area to higher grade area, then sanitize the external surface of material before loading in to dynamic pass box with a lint free cloth soaked in 0.2 µ filtered 70% IPA.
Note: While transferring material from higher grade area to lower grade area, there is no need to sanitize the material surface.
-
-
- The application of disinfectant shall be in such a manner so that whole the surface of item is covered by the used disinfectant i.e. bottom surface of item also.
- Keep the container/ material in the dynamic pass box & close the door and red light will glow.
- Remove the material from the other side using the same procedure as described in previous point.
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Note: In case of DPB, while transferring material from lesser clean area to more clean area allow a minimum hold time of 20 minutes for surface disinfection of material. However, the same is not required while transferring material from more clean area to lesser clean area.
-
-
- The UV tube shall be replaced after every 8000 running hours or ten months or whenever UV lamp is fused, whichever is earlier and record the activity in Annexure-I.
- Check the glow of UV light and Differential Pressure daily once in a day and record the details in Annexure-III.
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Note: Ensure that UV light is switched ON when door is closed and fluorescent light is OFF. Ensure UV light is OFF and fluorescent light ON when door is open. If UV light and fluorescent light not off or on as per sequence of operation or fuse then inform to the engineering department for rectification through breakdown intimation memo.
-
-
Cleaning:
- Ensure the pass box is in switch OFF condition.
- Clean the inner and outer surface of dynamic pass box of aseptic area with 0.2µ filtered 70 % IPA solution.
- Wipe the clean room side door from inside. Then close the clean room side door of static and dynamic pass box.
- Wipe the surface of UV & fluorescent tube light with lint free dry mop.
- Record the cleaning activity in respective formats.
-
Frequency: Daily or after operation or when required.
- Cleaning of the Pre filters shall be done Quaterly.
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Breakdown:
- In case of any failure, affix “Under Maintenance” tag and inform to engineering department for rectification.
- Preventive maintenance of the Dynamic Pass Box shall be carried out by engineering department.
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6. ABBREVIATIONS
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-
- SOP : Standard Operating Procedure
- DPB : Dynamic Pass Box
- HEPA : High Efficiency Particulate Air
- MB : Microbiology
- MLT : Microbial Limit Test
- SPB : Static Pass Box
- LED : Light Emitting Diode
- mm : Millimetre
- WC : Water Column
- DP : Differential Pressure
- UV : Ultra Violet
- µ : Micron
- % : Percentage
- IPA : Iso Propyl Alcohol
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7.REFERENCES
-
- Nil
8.ANNEXURES
-
- Nil
9.DISTRIBUTION DETAILS
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- MB
10.REVISION HISTORY
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- New
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