- Objective:
- To lay down a procedure on usage of Dynamic pass box.
- Scope
- This SOP is applicable for usage of Dynamic pass box ID.No PIDPB-01, PIDPB-02, PIDPB-03 and PIDPB-04.
- Responsibility
- Production Officer / Executive.
- Accountability
- Production Head shall be accountable for compliance of SOP.
- Abbreviations
- SOP : Standard Operating Procedure.
- IPA : Isopropyl alcohol
- IRM : Intermediate raw material
- UV : Ultra Violet
- Procedure
- There are four Dynamic pass boxes in the Production injection. The usage of these dynamic pass boxes is described herein:
- Dynamic Pass Box (ID No. PIDPB-01) – It is used for material transfer from controlled area to cooling area. The following items used in aseptic area are transferred through Dynamic Pass Box (ID.No PIDPB-01):Goggles, Media Plates, Sampling Aids, Aspirator Container with hosepipe, Pre-filters of Laminar Air Flow,Disinfactant spray bottles, DOP apparatus, particle counter, Filter integrity test apparatus, weighing balance, marker pen, air sampler, tool box. Any other item to be used inside Aseptic area is to be transferred after taking permission of the Production officer.
- Dynamic Pass Box (ID No. PIDPB-02) – It is used for transfer of material from cooling zone to vial filling room. The following items used in aseptic area are transferred through Dynamic Pass Box (ID.No PIDPB-02): Media Plates, Sampling Aids, Aspirator Container with hosepipe, Pre-filters of Laminar Air Flow, Disinfectant spray bottles, DOP apparatus, particle counter, Filter integrity test apparatus, weighing balance, marker pen, air sampler, tool box,filling and bunging machine change parts. Any other item to be used inside Aseptic area is to be transferred after taking permission of the Production officer.
- Dynamic Pass Box (ID No. PIDPB-03) – It is used for transfer of sanitized Aluminum seals, sealing machine change parts, Media Plates and Sampling Aids,Pre-filters of Laminar Air Flow, Disinfectant spray bottles, DOP apparatus, marker pen, air sampler and tools box. Any other item to be transferred only after taking permission of the Production officer.
- Dynamic Pass Box (ID No. PIDPB-04) – It is used for transfer of sterile raw material container, sampling aids from IRM Room to sampling room. Any other item to be used inside Aseptic area is to be transferred after taking permission of the Production officer.
- Operation of Dynamic Pass Box (ID No. PIDPB-01)
- Ensure that the power supplies of Dynamic pass box are connected.
- Clean and sanitize the entire dynamic pass box from aseptic area side with lint free duster soaked in 70 percent Isopropyl Alcohol.
- Ensure that no material is present in the pass box and both the doors of pass box are closed.
- Switch ON the pass box from the electric board and Check that the Ultraviolet light is properly working
- Check that interlocking of door is properly working
- Switch ON from the Mains to start the blower of pass box and check the reading on megnehelic gauge . It should be within range of 8 mm to 15 mm of water.
- Clean and sanitize the item to be transferred with lint free duster soaked in 20 % Virosil Pharma.
- Open the door of dynamic pass box from controlled area side. Load the items to be transferred to aseptic area and close the door.
- Keep the items to be transferred under UV light inside the pass box for at least 30 minutes.
- Inform the person on the other side for unloading the items in aseptic area.
- Open the door of dynamic pass box from aseptic area side, unload the items and close the door.
- Operation of Dynamic Pass Box (ID No. PIDPB-02)
- Ensure that the power supplies of Dynamic pass box are connected.
- Clean and sanitize the entire dynamic pass box from cooling zone and vial filling room side with lint free duster soaked in 70 percent Isopropyl Alcohol.
- Ensure that no material is present in the pass box and both the door of pass box are closed.
- Switch ON from the electric board and Check that the Ultraviolet light of Dynamic pass box is working properly.
- Check the interlocking of door is properly working
- Switch ON from the Mains to start the blower of pass box and check the reading on Megnehelic gauge .It should be within range of 8 mm to 15 mm of water.
- Open the door of dynamic pass box from cooling area. Load the items to be transferred to aseptic area and close the door.
- Inform the person on the other side for unloading the items in vial filling room.
- For unloading the item in vial filling room open the door and unload the items. Close the door immediately after unloading.
- Transfer the items to their respective storage places in vial filling room.
- Operation of Dynamic Pass Box (ID No. PIDPB-03)
- Ensure that the power supplies of Dynamic pass box are connected.
- Clean and sanitize the entire dynamic pass box from vial sealing room side and corridor side with lint free duster soaked in 70 percent Isopropyl Alcohol.
- Ensure that no material present in the pass box and both the door of pass box are closed.
- Switch ON from the electric board and Check that the Ultraviolet light of Dynamic pass box is properly working.
- Check the interlocking of door is properly working.
- Switch ON from the Mains to start the blower of pass box and check the reading on Megnehelic gauge .It should be within range of 8 mm to 15 mm of water.
- Open the door of dynamic pass box from corridor side and load the items to be transferred to vial sealing room and close the door.
- Keep the items to be transferred under UV light inside the pass box for at least 30 minutes.
- Inform the person on the other side for unloading the items in vial sealing room.
- Open the door of dynamic pass box from vial sealing room, unload the items, and close the door.
- Operation of Pass Box [ID No. PIDPB-04]
- Ensure that the power supplies of Dynamic pass box are connected.
- Clean and sanitize the entire dynamic pass box from IRM store side and sampling room side with lint free duster soaked in 70 percent Isopropyl Alcohol.
- Ensure that no material present in the pass box and both the door of pass box are closed.
- Switch ON from the electric board and Check that the Ultraviolet light of Dynamic pass box is properly working.
- Check the interlocking of door is properly working.
- Switch ON the Mains to start the blower of pass box and check the reading of megnehelic gauge should be within range.
- Clean and sanitize the outer surface of Raw material container to be transferred with lint free duster soaked in 20 percent Virosil Pharma.
- Open the door of dynamic pass box from IRM store side and load the sterile raw material container to be transferred to sampling room and close the door.
- Keep the containers to be transferred under UV light inside the pass box for at least 30 minutes.
- Inform the person on the other side for unloading the items in sampling room.
- Open the door of dynamic pass box from sampling room side and unload the containers.
- Immediately close the doors after unloading the containers.
- Record the details of items transferred through dynamic pass box in check list for material transferred through dynamic pass box, specimen attached with Annexure-1.
- Record the details of UV light burning in the format for Burning hours of U.V Lights specimen attached with Annexure-2.
- Record the readings of differential pressure in the format for differential pressure monitoring record (Dynamic Pass Box) attached with Annexure-3.
Annexure-1.
Check list for material transfer through dynamic pass box
| Material transferred through dynamic pass box PIDPB-01 | Date : | ||||||
| Sr. no | Name of material transferred | Material Transferred (Yes / No) | Transferred by | Checked by | Remarks (if any) | ||
| 1 | DOP apparatus | ||||||
| 2 | Particle counter | ||||||
| 3 | Media plates | ||||||
| 4 | Spectacles | ||||||
| 5 | Air sampler | ||||||
| 6 | Weight box | ||||||
| 7 | Tool box | ||||||
| 8 | Sampling Aids | ||||||
| 9 | Aspirator Container with hosepipe | ||||||
| 10 | Sterillium hand disinfectant bottles | ||||||
| 11 | Weighing balance | ||||||
| 12 | Marker pen | ||||||
| 13 | Spray bottles | ||||||
| 14 | Others | ||||||
| Material transferred through dynamic pass box PIDPB-02 | Date : | ||||||
| 1 | DOP apparatus | ||||||
| 2 | Particle counter | ||||||
| 3 | Media plates | ||||||
| 4 | Air sampler | ||||||
| 5 | Weight box | ||||||
| 6 | Paper roll | ||||||
| 7 | Tool box | ||||||
| 8 | Sampling Aids | ||||||
| 9 | Aspirator Container with hosepipe | ||||||
| 10 | Weighing balance | ||||||
| 11 | Marker pen | ||||||
| 12 | Spray bottles | ||||||
| 13 | Vial filling Machine parts | ||||||
| 14 | Filtered disinfectant solution | ||||||
| 15 | Filtered Water for Injection | ||||||
| 16 | Sterilized mop | ||||||
| 17 | Others | ||||||
| Material transferred through dynamic pass box PIDPB-03 | Date : | ||||||
| 1 | Flip off aluminum seals | ||||||
| 2 | Spray bottles | ||||||
| 3 | Plastic crates | ||||||
| 4 | Cleaning mop | ||||||
| 5 | Vial sealing machine parts | ||||||
| 6 | Iso Propyl Alcohol | ||||||
| 7 | DOP apparatus | ||||||
| 8 | Particle counter | ||||||
| 9 | Media plates | ||||||
| 10 | Tool box | ||||||
| 11 | Sampling Aids | ||||||
| 12 | Marker pen | ||||||
| 13 | Disinfectant solution | ||||||
| 14 | Water for injection | ||||||
| 15 | SS bucket | ||||||
| 16 | Others | ||||||
| Material transferred through dynamic pass box PIDPB-04 | Date : | ||||||
| 1 | Sterile Raw Material containers | ||||||
| 2 | Empty containers | ||||||
| 3 | Mannitol pouches | ||||||
| 4 | Others | ||||||
Annexure-2
Burning hours of U.V Lights
| Pass box ID No | No of burning hours | Cumulative burning hours | Done by | Checked by | Remarks |
| Date | |||||
| PIDPB-01 | |||||
| PIDPB-02 | |||||
| PIDPB-03 | |||||
| PIDPB-04 | |||||
| Date | |||||
| PIDPB-01 | |||||
| PIDPB-02 | |||||
| PIDPB-03 | |||||
| PIDPB-04 | |||||
| Date | |||||
| PIDPB-01 | |||||
| PIDPB-02 | |||||
| PIDPB-03 | |||||
| PIDPB-04 | |||||
| Date | |||||
| PIDPB-01 | |||||
| PIDPB-02 | |||||
| PIDPB-03 | |||||
| PIDPB-04 | |||||
| Date | |||||
| PIDPB-01 | |||||
| PIDPB-02 | |||||
| PIDPB-03 | |||||
| PIDPB-04 | |||||
Annexure-3
Differential pressure monitoring record (Dynamic Pass box)
| Location of Dynamic pass box (ID No.) | Standard range
(in mm of water) |
Observed differential pressure (in mm of water) | Done by | Checked by | Remarks |
| Date | |||||
| Cooling zone (PIDPB-01) | 8 to 15 | ||||
| Vial filling and bunging room (PIDPB-02) | 8 to 15 | ||||
| Vial sealing room (PIDPB-03) | 8 to 15 | ||||
| Sampling room (PIDPB-04) | 8 to 15 | ||||
| Date | |||||
| Cooling zone (PIDPB-01) | 8 to 15 | ||||
| Vial filling and bunging room (PIDPB-02) | 8 to 15 | ||||
| Vial sealing room (PIDPB-03) | 8 to 15 | ||||
| Sampling room (PIDPB-04) | 8 to 15 | ||||
| Date | |||||
| Cooling zone (PIDPB-01) | 8 to 15 | ||||
| Vial filling and bunging room (PIDPB-02) | 8 to 15 | ||||
| Vial sealing room (PIDPB-03) | 8 to 15 | ||||
| Sampling room (PIDPB-04) | 8 to 15 | ||||
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision
– 00 New SOP
