Working Principles compressed

(1) Dynamic Pass Box: Procedure on the working of Dynamic Pass Box.

(A) Objective:  This working principle is applicable for usage of Dynamic Pass Box in formulation plant of pharmaceutical company.

(B) Responsible Person:  Production Officer/ Executive are the required for following this working principle.

(C) Compliance: Production Head and QA Head are required for the compliance of this working procedure.

(D) Procedure: The usage of Dynamic Pass Box depends on the area in which it is installed and also on the type of Dynamic Pass Box Installed. For example; there are four types of Dynamic Pass Boxes as per respective Aseptic Area and are classified as:

  Dynamic Pass Box                                Use       Examples of Material Transfer
 

 

 

 

 

 

 

Dynamic Pass Box (01)

 

 

 

 

 

 

 

 

– It is used for transferring the material from controlled area to cooling area.

The name of the items which are used in Aseptic area are transferred through Dynamic Pass Box are given below:

– Goggles.

– Media Plates.

– Sampling Aids.

– Aspirator Container with hosepipe.

– Pre- filters of Laminar Air Flow.

– Disinfectant Spray Bottle.

PAO (Poly Alpha Olefin) Apparatus.

– Particle Counter.

– Filter Integrity test apparatus.

– Weighing Balance.

– Marker Pen.

– Air Sampler.

– Tool Box.

Note:

If an individual wants to use any other item to be transferred in Aseptic Area, that would be done only with the permission of Production Officer.

 

 

 

 

 

 

 

 

 

 

 

 

 

Dynamic Pass Box (02)

 

 

 

 

 

 

 

 

 

 

 

– It is used for transferring the material from cooling zone to vial filling room.

The name of the items which are used in Aseptic area are transferred through Dynamic Pass Box are given below:

– Goggles.

– Media Plates.

– Sampling Aids.

– Aspirator Container with hosepipe.

– Pre- filters of Laminar Air Flow.

– Disinfectant Spray Bottle.

PAO (Poly Alpha Olefin) Apparatus.

– Particle Counter.

– Filter Integrity test apparatus.

– Weighing Balance.

– Marker Pen.

– Air Sampler.

– Tool Box.

– Filling and Bunging Machine Change parts.

Note:

If an individual wants to use any other item to be transferred in Aseptic Area, that would be done only with the permission of Production Officer.

 

 

 

 

 

 

 

 

 

Dynamic Pass Box (03)

 

 

 

 

 

 

 

 

– It is used for transferring the material from vial sealing room side to corridor side.

It is used for the transfer of materials like:

Sanitized Aluminium Seals.

–  Seal machine change parts.

–  Media Plates.

– Sampling Aids

– Pre- filters of Laminar Air Flow.

– Disinfectant Spray Bottle.

PAO (Poly Alpha Olefin) Apparatus.

– Marker Pen.

– Air Sampler.

– Tool Box.

Note:

If an individual wants to use any other item to be transferred in Aseptic Area, that would be done only with the permission of Production Officer.

 

 

 

 

 

 

Dynamic Pass Box (04)

 

 

 

 

– It is used for transferring the material from IRM Store side to Sampling Room side.

It is used for the transferring of:

–  Sterile Raw Material Container.

– Sampling aids from IRM Room to Sampling Room.

Note:

If an individual wants to use any other item to be transferred in Aseptic Area, that would be done only with the permission of Production Officer.

 

Operating Principles of Dynamic Pass Boxes

S. No. Dynamic Pass Box (01) Dynamic Pass Box (02) Dynamic Pass Box (03) Dynamic Pass Box (04)
 

1.

Ensure that power supplies of respective pass box are to be connected. Ensure that power supplies of respective pass box are to be connected. Ensure that power supplies of respective pass box are to be connected. Ensure that power supplies of respective pass box are to be connected.
 

 

 

 

    2.

Clean and sanitize the entire respective pass box from cooling zone and vial filling room side with lint free duster which was soaked in 70% of Isopropyl Alcohol. Clean and sanitize the entire respective pass box from cooling zone and vial filling room side with lint free duster which was soaked in 70% of Isopropyl Alcohol. Clean and sanitize the entire respective pass box from vial sealing room side and corridor side with lint free duster which was soaked in 70% of Isopropyl Alcohol. Clean and sanitize the entire respective pass box from IRM store side and sampling room side with lint free duster which was soaked in 70% of Isopropyl Alcohol.
    3. Ensure that no material is present in the pass box and also make sure that the both of the doors of pass box are closed. Ensure that no material is present in the pass box and also make sure that the both of the doors of pass box are closed. Ensure that no material is present in the pass box and also make sure that the both of the doors of pass box are closed. Ensure that no material is present in the pass box and also make sure that the both of the doors of pass box are closed.
    4. Switch On the Pass Box from the electric board and check that the UV light of respective Pass Box is working properly. Switch On the Pass Box from the electric board and check that the UV light of respective Pass Box is working properly. Switch On the Pass Box from the electric board and check that the UV light of respective Pass Box is working properly. Switch On the Pass Box from the electric board and check that the UV light of respective Pass Box is working properly.
    5. Make sure that Interlocking system of respective pass box is working properly. Make sure that Interlocking system of respective pass box is working properly. Make sure that Interlocking system of respective pass box is working properly. Make sure that Interlocking system of respective pass box is working properly.
    6. Switch on from the Mains to start the blower of pass box and also check the reading on Megnehelic Gauge and make sure that the reading should be within the range of 8 mm to 15 mm of water. Switch on from the Mains to start the blower of pass box and also check the reading on Megnehelic Gauge and make sure that the reading should be within the range of 8 mm to 15 mm of water. Switch on from the Mains to start the blower of pass box and also check the reading on Megnehelic Gauge and make sure that the reading should be within the range of 8 mm to 15 mm of water. Switch on from the Mains to start the blower of pass box and also check the reading on Megnehelic Gauge and make sure that the reading should be within the range.
  

 

    7.

Clean and Sanitize the transferred items with lint free duster which is soaked in 20% of Virosil Pharma.  

 

 

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    8.

Open the door of respective pass box from controlled area side and start loading the items; transferring to aseptic area and than in last close the door. Open the door of respective pass box from cooling area and start loading the items; transferring to aseptic area and than in last close the door. Open the door of respective pass box from corridor side and start loading the items; transferring to vial sealing room and than in last close the door. Open the door of respective pass box from IRM (Intermediate Raw Material) Store side and start loading the sterile raw material container; transferring to Sampling room and than in last close the door.
    9. Keep the transferred items inside the pass box under the exposure of UV Light for at least 30 minutes.  

 

 

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Keep the transferred items inside the pass box under the exposure of UV Light for at least 30 minutes. Keep the transferred items inside the pass box under the exposure of UV Light for at least 30 minutes.
   10. Inform the person present on the other side for unloading the transferred items in aseptic area. Inform the person present on the other side for unloading the transferred items in vial filling room. Inform the person present on the other side for unloading the transferred items in vial sealing room. Inform the person present on the other side for unloading the transferred items in sampling room.
   11. Open the door of the respective pass box from aseptic area side and then unload the transferred items and close the door immediately after unloading. Keep the material in the pass box and wait for 5 minutes for stabilizing the pass box. Open the door of the respective pass box from vial filling room and then unload the transferred items and close the door immediately after unloading. Keep the material in the pass box and wait for 5 minutes for stabilizing the pass box. Open the door of the respective pass box from vial sealing room and then unload the transferred items and close the door immediately after unloading. Keep the material in the pass box and wait for 5 minutes for stabilizing the pass box. Open the door of the respective pass box from sampling room side and then unload the transferred items and close the door immediately after unloading. Keep the material in the pass box and wait for 5 minutes for stabilizing the pass box.
  

 

   12.

 

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Transfer the items to their respective storage places in vial filling room.  

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   13.

 

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Record the details the transferred items in the check- list through the respective pass box.
 

 

  

   14.

 

 

 

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Record the details of UV Light burning in the format available with the name of format hours of U.V. Light specimen attached with Annexure- 1.
  

 

   15.

 

 

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Record the readings of differential pressure in the format for differential pressure monitoring record across the HEPA filter which should be between 10- 15 pascals.

ANNEXURE- 1

Burning Hours of U.V. Light

Pass box id no. no. of burning hours. cumulative burning hours.  

     done by

 

  checked by

 

    remarks

(2) Static Pass Box: 

Operating Principles of Static Pass Box

  1. This equipment is installed on the wall between the clean room and the other room.
  2. The pass box has two doors at its extreme ends. One door opens in the clean room and other door open in the other room.
  3. These doors are electrically interlocked type so that any one door can be opened at a time. This avoids direct flow of air from the clean room to the other room or vice versa.
  4. This also obviates the need to open the clean room door frequently for transferring of material from & into the clean room. Thus, it helps in achieving the aim of material transfer without disturbing the cleanliness level of the clean room.
  5. Ensure that power supplies of respective pass box are to be connected.
  6. Clean and sanitize the entire respective pass box from cooling zone and vial filling room side with lint free duster which was soaked in 70% of Isopropyl Alcohol.
  7. Switch on the Pass Box from the electric board and check that the UV light of respective Pass Box is working properly.
  8. Make sure that one door should be closed while transferring the material.

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