Total Pharmaceutical Solution

SOP for Operation And Cleaning of Dynamic Pass Box

1.0 PURPOSE:

To lay down the procedure for operation and cleaning of dynamic pass box.

2.0 SCOPE:

SOP for operation and cleaning of dynamic pass box is applicable for operation and cleaning of dynamic pass box in Injectable and OSD block at (Company name).

3.0 DEFINITIONS:

Nil

4.0 RESPONSIBILITY:

4.1. Production / Packing /Microbiology / Warehouse Operator / Officer is responsible for operation and cleaning of dynamic pass box. 
4.2. Production / Packing / Microbiology / Warehouse Officer / Executive is responsible for execution of the procedure.
4.3. Head-Production / Packing / Microbiology / Warehouse is responsible to ensure the compliance of the procedure.

5.0 PROCEDURE:

5.1. Precaution: 
5.1.1. Ensure that main power supply of dynamic pass box is in “ON” condition.
5.1.2. Ensure that the HEPA filter blowers are in “ON” condition.
5.1.3. Ensure that differential pressure across the HEPA filter is within specified limit (7-15 mm of WC).
5.1.4. Ensure that the electromagnetic door interlocking system is functioning properly.
5.1.5. Ensure that both door of dynamic pass box should not open at the same time.
5.1.6. Switch “ON” the blower of dynamic pass box at least for 15 minutes before operation of dynamic pass box (If applicable).
5.1.7. Do not touch HEPA filter surface with sharp objects.
5.2. Operating Procedure:
5.2.1. Press the red color rocker switch to down side to switch “ON” the blower and hence the airflow starts. The rocker switch will glow in red colour. Press the same button to upper side to switch “OFF “the blower and hence the airflow stops.
5.2.2. The reading on magnehelic gauge indicates differential pressure across the HEPA filter.
5.2.3. Ensure that the DP reading should be maintained between 7-15 mm of water column.
5.2.4. Press the red colour push button to open the dynamic pass box door from one side. If the dynamic pass box door of one side is opened then opposite side door shall be in locked condition and there will be glowing of red colour lamp indication.
5.2.5. Place the material in dynamic pass box. Once the material is kept inside, close the door.
5.2.6. In case of Injectable area during transfer of material from less clean side area to more clean side area from dynamic pass box, clean the external surface of the container with clean lint free cloth dipped in scheduled disinfectant solution. After completion of interlocking time (15 min.) opposite side door will glow green indicator lamp indicating ready for open condition.
5.2.7. Another side person shall press the red colour push button to open the pass box door.
5.2.8. Take out the material from dynamic pass box and close the door.
5.2.9. For transfer of material from more clean side area to less clean side area, place the material in dynamic pass box and close the door. Open the opposite side door and remove the material from dynamic pass box.
5.3. Cleaning Procedure:
5.3.1. In case of OSD and warehouse area dynamic pass boxes clean the inside and outside surfaces of the dynamic pass box with lint free cloth dipped in scheduled disinfectant solution, hold it for validated contact time. Clean the inner and outer surface of the pass box with lint free cloth dipped in purified water and followed by dry lint free cloth.
5.3.2. In case of Injectable non critical area dynamic pass boxes clean the inside and outside surfaces of the dynamic pass box with lint free cloth dipped in scheduled disinfectant solution, hold it for validated contact time. Clean the inner and outer surface of the dynamic pass box with lint free cloth dipped in water for injection and followed by dry lint free cloth.
5.3.3. In case of Injectable, critical area dynamic pass boxes clean the inside and outside surfaces of the dynamic pass box with lint free cloth dipped in filtered scheduled disinfectant solution, hold it for validated contact time. Clean the inner and outer surface of the pass box with lint free cloth dipped in filtered water for injection and followed by dry lint free cloth.
Frequency: Once in a day / preferably when no material kept inside of dynamic pass box.
5.4. Monitor and record the differential pressures across HEPA filter of dynamic pass box as per Annexure-I
5.5. Record the operation and cleaning details as per Annexure-II.

6.0 ABBREVIATIONS:

SOP : Standard Operating Procedure 
HEPA : High Efficiency Particulate Air
mm : Millimeter
WC : Water Column
DP : Differential Pressure
WFI : Water For Injection
OSD : Oral Solid Dosage

7.0 REFERENCES:

Nil

8.0 LIST OF ANNEXURES:

Annexure-I: Differential pressure monitoring record. 
Annexure-II: Instrument/Equipment operation and cleaning record.

SOP for operation and cleaning of dynamic pass box

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