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SOP on usage of Dynamic pass box

  • SOP on usage of Dynamic pass box
  • Objective:To lay down a procedure on usage of Dynamic pass box.
  • Scope:
  • This SOP is applicable for usage of Dynamic pass box in formulation plant of pharmaceutical company.
  • Responsibility:
  • Production Officer / Executive shall be responsible for follow the procedure mentioned in this SOP.
  • Accountability:
  • Production Head and QA Head shall be accountable for compliance of SOP.
  • Procedure:
  • The usage of  dynamic pass boxes depend on area in which installed ,For eg. four dynamic pass boxes as per respective aseptic area is described herein:
  • Dynamic Pass Box (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:
  • Goggles, Media Plates, Sampling Aids, Aspirator Container with hosepipe, Pre-filters of Laminar Air Flow,Disinfactant spray bottles, PAO 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 (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 :
  • Media Plates, Sampling Aids, Aspirator Container with hosepipe, Pre-filters of Laminar Air Flow, Disinfectant spray bottles, PAO 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(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, PAO 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 (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 (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
  • 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 (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 [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.
  • Record the details of UV light burning in the format for Burning hours of U.V Lights specimen attached with Annexure-I.
  • Record the readings of differential pressure in the format for differential pressure monitoring record.
  • List of Annexure / Format
  •  Burning hours of U.V Lights -Annexure-I
  • Reason for revision
  • New SOP.
  • Abbreviations
  • IPA      :           Isopropyl alcohol
  • IRM     :           Intermediate raw material
  • UV       :           Ultra Violet

 

Annexure-I

Burning hours of U.V Lights

Pass box ID No No of burning hours Cumulative burning hours Done by Checked by Remarks
 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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