A dynamic pass box is a cubicle box which has got interlocked doors located on both sides. This protects the controlled environment from being polluted while the transfer of material is taking place inside.

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Dynamic Pass Box equipment are made of powder coated high grades stainless steel (304 / 316 / 316 L) with international quality standard components including mechanically or electrically interlocked doors and UV light. These dynamic pass box equipment are equipped with suction filter made of stainless steel with 95% down to 5µ efficiency (EU-4rating) and supply filter made of aluminum with 99.999% down to 0.001 µ (EU-14 Rating.) An interlock guard system controls the inlet and the outlet of PASS BOX not be opened at the same time, in order to prevent the cross contamination.

Specifications:

Product	Dynamic Pass Through Box
Construction	Stainless Steel 304 / 316 / 316L
Door	Solid door w/ mechanical or electrical interlocked
Window	Tempered Glass
UV Lamp	Optional
HEPA Filter	Optional
Suction Filter	Stainless Steel w/ 95% down to 5 µ Efficiency (EU-4 Rating.)
Supply Filter	Aluminum w/ 99.999% down to 0.001 µ (EU-14 Rating.)
Blower	Branded Heavy duty
Noise	<78
Power Supply	220 / 230 Volts
Accessories	Hour meter, Magnehelic / Minihelic Pressure Gauge
Electricals	Hour Meter, Fluorescent light, UV light, Electromagnet for door interlocking, Buzzer and Indicator lamps
Air Shower Facility	Optional
Cleanliness	Class 100
Certifications	CE and ISO

Application:

Pharmaceutical industries	Chemical research laboratories	Electronic industry
Semiconductor production	Food processing industry

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.