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DESIGN QUALIFICATION PROTOCOL

FOR
DYNAMIC PASS BOX

CUSTOMER:

EQUIPMENT: DYNAMIC PASS BOX

(_______W x ______D x ______H mm)

SUBMITTED BY:

PHARMA ENGINEERS

PLO T N O. 1 1 3 / A / 1 , L A NE 8 , P HA SE I I,

I DA C HE RLA PA LL I, H YD ERA BA D - 5 0 0 0 5 1 .

Te l N o.9 1 - 4 0 2 7 2 6 1 1 1 3 , 2 7 2 6 1 1 1 4
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DESIGN QUALIFICATION PROTOCOL APPROVAL

This document is prepared by the documentation team of M/S. PHARMA ENGINEERS

for
EQUIPMENT : DYNAMIC PASS BOX (DPB-01)
PLANT /PROJECT :
CLIENT :
Hence this document before being effective shall be approved by Client / Customer
M/s. PHARMA ENGINEERS:

Name Designation Signature Date

Prepared By

Reviewed By

CLIENT / CUSTOMER:

Name Designation Signature Date

Reviewed By

Approved By
Client:

Supplier/ Manufacturer: PHARMA ENGINEERS, HYDERABAD

Equipment: DYNAMIC PASSBOX (_______W x ______D x _______H mm)

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DESIGN QUALIFICATION (DQ)

TABLE OF CONTENT

1. OBJECTIVE ...............................................................................................................................4

2. SCOPE ........................................................................................................................................4

3. RESPONSIBILITIES ...............................................................................................................5

4. EQUIPMENT DESCRIPTION ..............................................................................................6

5. SYSTEM ARCHITECTURE ...................................................................................................7

6. TECHNICAL SPECIFICATIONS: ........................................................................................7

7. SAFTEY FEATURES & INTERLOCKS..............................................................................9

8. UTILITIES REQUIRED ........................................................................................................10

9. LIST OF DRAWINGS AND DOCUMENTS ENCLOSED ............................................10

Client:

Supplier/ Manufacturer: PHARMA ENGINEERS, HYDERABAD

Equipment: DYNAMIC PASSBOX (_______W x ______D x _______H mm)

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DESIGN QUALIFICATION (DQ)

1. OBJECTIVE

The objective of this document is to comply with URS Document Number:

________________________ pertaining to design specification of Dynamic Pass
Box DPB -01.

2. SCOPE

Design Specifications of Dynamic Pass Box Comprising of the following main

Equipments.

• Material of Construction
• Blower Motor Assembly
• Filters
• Door Interlocks
• Control Panel
Client:

Supplier/ Manufacturer: PHARMA ENGINEERS, HYDERABAD

Equipment: DYNAMIC PASSBOX (_______W x ______D x _______H mm)

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DESIGN QUALIFICATION (DQ)

3. RESPONSIBILITIES

M/s. Pharma Engineers:

1. Shall agree and follow the URS.

2. To Prepare the detailed engineering drawings.
3. To submit the technical details of equipment as per the scope of supply.
4. To ensure safe delivery of equipment
5. To Complete the equipment qualification.
Client:

Supplier/ Manufacturer: PHARMA ENGINEERS, HYDERABAD

Equipment: DYNAMIC PASSBOX (_______W x ______D x _______H mm)

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DESIGN QUALIFICATION (DQ)

4. EQUIPMENT DESCRIPTION

Dynamic Pass box is designed to obtain cleanliness level complies with

Class 100/ISO-5 at rest condition and ability to sweep away contaminants
generated during handling and to maintain the required classified
conditions.

MAXIMUM CONCENTRATED LIMITS

(PARTICLE/M3 OF AIR) FOR PARTICLE EQUAL &
ISO STD
LARGER THAN THE CONSIDERED SIZES AS PER
ISO 14644-1 (2015)
ISO-5 0.5 micron 5 microns
Particles per Cubic
3520 29
Meter

Dynamic Pass box chamber is constructed in stainless steel of grade SS 304,

20G, with two doors of both side operation and the chamber size shall be
square/rectangle. The inner top portion of Dynamic Pass box is housed with
blower assembly followed by HEPA Filter and bottom portion shall have
return air path.

Blower was sized to maintain the laminar air below the HEPA Filter and also
to take care of pressure drop across the filter. The speed of the blower shall
be adjusted with Speed regulator.

The air is drawn through pre-filter Air and blows over the HEPA Filter with
a velocity of 90 feet per minute; however, the variation of velocity is accepted
up to ±20 feet per minute. Thus, the chamber is maintained for a class of
cleanliness confirms to Class 100 / ISO-5.

Pressure differential across the HEPA Filter shall be monitored with a

differential pressure gauge.

Lights shall be provided at working area. Approx. 400 Lux intensities shall
be maintained.

Required ports are provided for D.O.P and pressure drop measurement
Client:

Supplier/ Manufacturer: PHARMA ENGINEERS, HYDERABAD

Equipment: DYNAMIC PASSBOX (_______W x ______D x _______H mm)

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DESIGN QUALIFICATION (DQ)

5. SYSTEM ARCHITECTURE

LOWER CLASSIFIED HIGHER CLASSIFIED

DESCRIPTION
AREA AREA
Room Names Corridor-1 Solvent Store

Classification Grade CNC NCNC

Pressure Maintained AMB AMB

6. TECHNICAL SPECIFICATIONS:
NOMENCLATURE:
Equipment TAG Number DPB – 01
Manufacturers name M/s Pharma Engineers
Qty 01 No.
CONSTRUCTION DETAILS:
Internal size (width x Depth x Height)
600 x 600 x 1000 mm
mm
External size (width x Depth x Height)
740 x 680 x 1750 mm
mm
M.O.C SS 304, 20G, Matt Finish
BLOWER DETAILS
EBM PAPST INDIA PRIVATE
Make
LIMITED
Model D4E 180-CA02-02
Power 405 W, 1 Ø, 50 Hz
R.P.M 1200 RPM
Qty 1 No
FILTRATION SCHEME WITH IN EQUIPMENT
FRESH AIR FILTER
Make M/s. ULTRAFIL AIR SYSTEMS
Type BOX Type
Test Method EN 779
Filter Classification as per EN779 M-5
Media Synthetic media
Avg.efficiency at 0.4 micron 40 ≤ Em < 60%
Equivalent particle size in terms of market
5 microns–Un authenticated data
language
Size 160 X 160 X 50 mm
Client:

Supplier/ Manufacturer: PHARMA ENGINEERS, HYDERABAD

Equipment: DYNAMIC PASSBOX (_______W x ______D x _______H mm)

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DESIGN QUALIFICATION (DQ)

Qty 1No.
PRE-FILTER
Make M/s. ULTRAFIL AIR SYSTEMS
Type Flange Type
Test Method EN 779
Filter Classification as per EN779 G-4
Media Synthetic media
Avg. arrestance of synthetic dust 90 ≤ Am
Equivalent particle size in terms of market
10 microns –Un authenticated data
language
Size 450 X 305 X 50 mm
Qty 2 No.
HEPA FILTER
Make AAF
Type of filter BOX
Test method EN 1822
Filter classification H-14
Avg.efficiency at MPPS 99.995%
Media MOC Micro fiber glass
Washable compatibility No
Equivalent particle size in terms of market 99.999% down to 0.3 micron–Un
language authenticated data
Size 450 X 450 X 69 mm
Qty 1 No’s
I.P.D of Filter (Approximate) 10 to 15 mm of WC
F.P.D of Filter (Approximate) 50 mm of WC
NOTE: I.P.D & F.P.D values change based on AIRFLOW; hence customer should set
the limits after commissioning.
INSTRUMENTATION DETAILS
DIFFERENTIAL PRESSURE GAUGES
Make DWYER
Type Analog Gauge
Range 0 to 50 mm of WC
Location Across HEPA Filter
Qty 1 No
CFL LIGHT
Make Crompton
Client:

Supplier/ Manufacturer: PHARMA ENGINEERS, HYDERABAD

Equipment: DYNAMIC PASSBOX (_______W x ______D x _______H mm)

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DESIGN QUALIFICATION (DQ)

Length 4’
Qty 1 No
UV LIGHT
Make PHILIPS
Length 4’
Qty 1 No.
HOUR METER
Make Selec
Range 999999 Hrs
Qty 01 No’s
ACCESSORIES
ON/OFF Switch for Blower 6 Amps Selector Switches / 01 No’s
ON/OFF Switch for UV/ CFL LIGHT 6 Amps Selector Switches / 01 No’s
Door handles and hinges SS 304 with Matt finish
PAO, ATM & DOP Ports SS 304 with Matt finish
Gasket Food grade gasket

7. SAFTEY FEATURES & INTERLOCKS

Sr.No. ACTIVITY ACTION ALARMS

The other side door is
locked.
CFL light ON. No Alarm
1. One Side door opens
UV light OFF. Provided
Display indicates
“WAIT”
Indication is
Door opened for more Beep sound blows until
2. provided with
than 2min the door closes
Alarm

Door release button Door is ready to open. No Alarm

3.
pressed. Display indicates “GO” Provided
Client:

Supplier/ Manufacturer: PHARMA ENGINEERS, HYDERABAD

Equipment: DYNAMIC PASSBOX (_______W x ______D x _______H mm)

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DESIGN QUALIFICATION (DQ)

When one side door is

opened, the another side
Jumpers for door
door is locked for a No Alarm
4. interlock when door
period of Provided
release button pressed
4sec/30sec/60sec
whichever is set .
UV light ON & CFL light
OFF No Alarm
5. Both doors closed
Display indicates Provided
“LOCKED”
Indication is
Beep sound blows, and
6. Blower Over loaded provided with
blower is switched OFF
Alarm

8. UTILITIES REQUIRED

S.NO DESCRIPTION CONSUMPTION

1. Electricity 3Ø

9. LIST OF DRAWINGS AND DOCUMENTS ENCLOSED

ENCLOSED
S.NO DRAWING NAME
(YES / NO)
1. GA Drawing for Pass box
2. DPB location layout
3. Electrical Drawings