DESIGN QUALIFICATION PROTOCOL

FOR
STATIC PASSBOX
(MODEL NO.: AJE/SPB/2DS/01)

CUSTOMER:
XXXXXX

SUBMITTED BY:
AJ ENTERPRISES
Plot No.: 21, SJB Hills, Bachupally,
Quthbullapur - Mdl, Rangareddy-dist.
 DESIGN QUALIFICATION PROTOCOL FOR STATIC PASSBOX

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DESIGN QUALIFICATION PROTOCOL APPROVAL

This document is prepared by the team of M/S. AJ Enterprises for

EQUIPMENT NAME : STATIC PASSBOX

NO. OF DOORS : 2 DOOR
TYPE OF MOUNTING : FLOOR MOUNTING
CUSTOMER : XXXX

Hence, this document before being effective shall be approved by the Customer.

Supplier: AJ Enterprises

Name Designation Signature Date

Customer: XXX

Name Designation Signature Date

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TABLE OF CONTENT
1.0 OBJECTIVE.............................................................................................................................4
2.0 SCOPE......................................................................................................................................4
3.0 RESPONSIBILITIES...............................................................................................................4
4.0 EQUIPMENT DESCRIPTION................................................................................................5
5.0 TECHNICAL SPECIFICATIONS...........................................................................................6
6.0 DETAILS OF UTILITIES........................................................................................................8
7.0 IDENTIFICATION OF COMPONENTS FOR CALIBRATION...........................................8
8.0 MATERIAL OF CONSTRUCTION........................................................................................8
9.0 SAFETY FEATURES & INTERLOCKS................................................................................9
10.0 CHANGE CONTROL............................................................................................................10
11.0 LIST OF DOCUMENTS........................................................................................................10
12.0 ABBREVIATIONS................................................................................................................11

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1.0 OBJECTIVE
The objective of this document is to Design, Engineer and Supply the Static Passbox, Model:
AJE/SPB/2DS/01 as per cGMP guidelines and to provide assurance that the equipment is
manufactured as per the URS and it comply with the scope of supply.

2.0 SCOPE
The scope of this qualification document is limited to the Design Qualification of Static
Passbox, Model: AJE/SPB/2DS/01.
The qualification of any additional accessories apart from those specified in this protocol is
not within the scope of this qualification document.
The qualification of support utilities is not within the scope of this document.

3.0 RESPONSIBILITIES
Customer:
 To provide URS for the equipment.
 To verify and approve the qualification document.

Supplier/ Manufacturer:
 Shall agree and follow the URS.
 To prepare the detailed engineering drawings.
 To submit the technical details of equipment as per the scope of supply.
 To ensure safe delivery of equipment to the user site.
 To ensure the proper installation and commissioning of the equipment.

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4.0 EQUIPMENT DESCRIPTION

Static Passbox is a cubicle floor mounting type box used to transfer the materials from one
room to another. The structure is double walled construction made of SS304 with SS pipe
channels between the walls and SS 304 doors on both sides of operation.

Doors are equipped with double walled flush glass viewing window with SS handles and SS
hinges.

The doors are interlocked such that they cannot be open at the same time, to prevent pressure
losses and cross contamination. Timer setting for adjusting the delay time for door opening.

Feather touch switches for door release at both sides with LED display indicating the door
status (LOCKED, GO, WAIT, DOOR OPEN, CLOSE DOOR etc.).

Provided with CFL light, UV light and hour meter for UV light.

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5.0 TECHNICAL SPECIFICATIONS

S. No. Description Specification
Main Body
Make AJE
Model AJE/SPB/2DS/01
MOC SS 304, Matt Finish No. 4
1. Thickness Sheet - 1.6 mm, Channel - 50 mm
Type of Mounting Floor Mounting
Work Area (Width x Depth x Height) 600 x 600 x 790 mm
Overall size (Width x Depth x Height) 720 x 680 x 935 mm
Quantity 01 No.
SS Solid Hinges
Make AJE
6. MOC SS 304
Size 40 mm
Quantity 8 Nos.
View Window
Make Saint-Gobain
7. MOC Toughened Glass
Size (Length x Width x Thickness) 395 x 245 x 6 mm
Quantity 4 Nos.
CFL Light
Make Oreva
12. Length 1’
Power 10 W
Quantity 01 No.
UV Light
Make Oreva
16. Length 1’
Burning Hours 7200 Hours
Quantity 01 No.
Hour Meter
Make Selec
Model TT412
Display 6 Digits
99999.9 sec / min / hr
20.
Range or
999999 sec / min / hr
Accuracy 0.05 %
Supply Voltage 90 -270 V AC / DC
Quantity 01 No.
Electromagnetic Locks
Make JSI
27.
Rating 24V DC/ 250 mA
Quantity 02 Nos.

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S. No. Description Specification

Relays
Make JSI
28. Contact Material Silver Alloy
Contact Rating 230V AC/ 2 A
Quantity 02 Nos.
Micro Controller
Make JSI
Model LR153-S
29.
Rating 80 -280 V, AC 50 Hz
Power 50 W
Quantity 01 No.
Door Release Switches
Make JSI
30. Type Feather Touch
Rating 6A
Quantity 02 Nos.
6.0 DETAILS OF UTILITIES

S. No. Description Specifications

Electrical
Phase 1 Phase
1. Voltage 230V
Frequency 50 Hz
Electric Consumption 1 KW (approximate)

7.0 IDENTIFICATION OF COMPONENTS FOR CALIBRATION

Following are the components that require calibration:

S. No. Component Name

1. Hour Meter

8.0 MATERIAL OF CONSTRUCTION

S. No. Description Specifications

1. Body structure SS 304, Matt Finish No.4
2. Door Handle and Hinges SS 304
3. Gasket Food grade
4. View Window Toughened Glass

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9.0 SAFETY FEATURES & INTERLOCKS

S. No. Description Specifications

The other side door will be locked.
CFL light turns ON and UV light turns OFF.
Any one side door in open
1. Display at locked door indicates “WAIT”
condition
(Locked CFL blinking) and display at opened
door indicates “DOOR OPEN”.
Door in open condition for A buzzer will be blown and the display at the
2.
more than set time doors will indicate “CLOSE DOOR”
3. Door release button pressed Display shows “GO” and Door is ready to open
Both doors in closed UV light turn ON and CFL light turns OFF.
4.
condition Display shows “LOCKED”.

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10.0 CHANGE CONTROL

Changes in the agreed design, any addition or modification in the equipment after its supply
shall be addressed through the well-defined document and it shall be duly incorporated on
mutual agreement of the Customer and the Manufacturer, after verifying the technical
feasibility of the same subjected to cost implications, if any.

11.0 LIST OF DOCUMENTS

The list of documents to be provided at the time of equipment delivery are as follows.

S. No. Document Name

1. GA Drawing

2. Electrical Drawing

3. Operation Manual

4. Tests Certificates

5. DQ, IQ & OQ Protocols

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12.0 ABBREVIATIONS
AJE : AJ Enterprises
CFL : Compact Fluorescent Lamp
DQ : Design qualification
GA : General Arrangement
GMP : Good Manufacturing Practice
Hr : Hour
Hz : Hertz
IQ : Installation qualification
JSI : Je Success Instruments
KW : Kilowatt
mm : millimeter
MOC : Material of Construction
No. : Number
OQ : Operational qualification
SS : Stainless steel
URS : User Requirements Specifications
UV : Ultra Violet
V : Volts

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