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Pass Box for Clean room and it validaton

Pass Box for Clean room and it validation

Definitions of Pass Box:

Pass Box is specifically designed that aids in the material transfer without much personnel movement in clean rooms and also work like a barrier between classified and unclassified area.two types of pass box is used in pharmaceutical industry that is-

1.Static Pass Box

2. Dynamic Pass Box

Static Pass Box:Image result for static passbox

Static pass boxes are generally simple boxes that is mounted between two areas and static pass box is also known as passive pass boxes that is generally used for material transfer between two area.

Static pass box equipment, fabricated with powder coated 304 / 316 grades stainless steel and high quality components and are capable of eradicating pollutants completely from the air. These static pass boxes are installed in manufacturing areas and filter the incoming air in order to keep the air free from dust and other contaminants. With UV light along with hour meter.

Dynamic Pass Box:Image result for dynamic passbox

Dynamic pass box  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.

Dynamic pass box works like an airlock or Laminar Air Flow unit. Dynamic pass boxes may be Cascade, Sink or Bubble type similar to the airlocks in pharmaceuticals

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.

 

Specification of Static Pass Box some  Point mentioned here but not limited

Static Pass Box is specifically designed that aids in the material transfer without much personnel movement.the Static Pass Box also acts as a hindrance for entrance of contaminants in clean room and other classified areas.

Specifications :

  • Generally Made with powder coated Mild Steel, SS 304 / SS 316/ SS 316L or a combination of both
  • Double Walled Construction
  • Doors equipped with double walled flush glass view panels
  • SS Handles and SS hinges
  • Electro-magnetic Interlocking
  • Indicator on either side
  • Internal covings for easy cleaning
  • Door Release Switch on either side
  • Power Supply : 230V AC 1-Ø 50HZ

Also some times designed with addition specification that is :

  • Mechanical Interlocking
  • Provision for ventilation with perforated grille
  • U. V. Light with Hour Meter with interlocking arrangement to put-off U.V. Light if any of the door opens
  • Three wall construction for floor mounting
  • Floor mounted construction with three side wall structure & Door Drop Seal
  • Support stand for mounting the pass box
  • Flange for filling the gap between the pass box and the clean room wall
  • Fluorescent light with interlocking arrangement to put on light when the doors are in closed position.

Specification of Dynamic Pass Box some major Point mentioned here but not limited

Dynamic Pass Box assists in transfer of materials driven through a controlled environment but without much personnel movement. Dynamic Pass Box helps in prevention of contaminants entrance either in the clean room or between various classified areas.
Specifications :

  • Two Stage filtration
  • Available in powder coated Mild Steel, SS 304 / SS 316/ SS 316L or a combination of both.
  • EU6 – Prefilter (95% down to 5 micron)
  • EU14 – HEPA Filter – Supply (99.999% down to 0.3 micron)
  • Dynamically balanced Motor-blower facilitated with suspension arrangement to minimize the noise level
  • Double walled flush glass view panels provided with doors
  • SS Handles and SS hinges
  • Internal covings for easy cleaning
  • Electro-magnetic Interlocking
  • Indicator on either side
  • Door Release Switch on either side
  • Differential Pressure Gauge .
  • On / Off Switch for Motor
  • DOP Test Port

Also some times designed with addition specification that is :

  • Mechanical Interlocking
  • U. V. Light with Hour Meter with interlocking arrangement to put-off U.V. Light if any of the door opens
  • Floor mounted construction with three side wall structure & Door Drop Seal
  • Support Stand for mounting the pass box
  • Flange for filling the gap between the pass box and the clean room wall
  • Audio / Visual alarm for blower tripping with Fault Acknowledgement & Reset Switch
  • Clean Down Timer with Operation Hold Indicator & interlocking to put on fluorescent lights only after clean down time over
  • Fluorescent light with interlocking arrangement to put on light when the doors are in closed position

Dynamic Pass Box Validation for cleanliness:

Following  Validation Test shall be performed during Installation and specified pre-defined frequency

1.Air Flow

Air Flow   should be Unidirectional air flow system

Test Frequency- During Installation and Re validation Every Year

2. HEPA Filter Integrity Test 

  • Apparatus Required: –    Aerosol Photometer. 
  • Acceptance Criteria:-  Leakage rate is NMT 0.01%.
  • Operating Procedure:-
  • Integrity checking of filters should be carried out by using Calibrated photometer.
  • Following apparatus should be used while integrity testing of filters.
  • An aerosol photometer having threshold sensitivity below 10 microgram / liter  for 0.3 micron particles of aerosolised Poly Alfa Olefin (PAO) and a sampling rate of 1 Cubic Feet Per Minute (CFM). Set up the                  Aerosol generator and fill the DOP/PAO liquid to minimum 1/2 of its capacity.

 

3. Non Viable Particulate count test.

  • Apparatus Required: – Discrete particulate counter. 
  • Acceptance Criteria:-

Acceptance Criteria:

The average particle concentration at each of the particle measuring location falls below the class limit.

4.Procedure for particulate count recovery test

Apparatus Required: –  Discrete particulate counter. 

  • Acceptance Criteria:-

Clean room takes to return from a contaminated condition to the specified clean room condition. This should not take more than 15 min. In accordance with ISO 14644-3 

5Viable Particulate count test.

 

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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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