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:
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:
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
5. Viable Particulate count test.
