DOC. NO.

: DQ-162/17-18
DESIGN QUALIFICATION
REV. NO. : 00
AUTOMATIC EXTERNAL VIAL
MODEL NO: NKEW-200
WASHING MACHINE

MACHINE NAME : AUTOMATIC EXTERNAL VIAL

WASHING MACHINE

CLIENT NAME & ADDRESS : GMH ORGANICS.

PLOT NO. 5, VILLAGE KUNJHAL,
JHARMAJRI, BADDI,
DIST. SOLAN (H.P) – 173205.

MODEL NO. : NKEW-200

DOCUMENT NAME : DESIGN QUALIFICATION

DOCUMENT NO. : DQ-162/17-18

MACHINE SR. NO. : EW-201/08/17-18, TT-103/32/17-18

REVISION NO. : 00

WORK ORDER NO. : MC/044-EC/17-18

P.O. NO. & DATE : GMH/PO/17-18/0723/BADDI & 03.10.2017

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APPROVAL TABLE

SIGN FOR ROLE / NAME DATE SIGNATURE

Preparation Mrs. Asha Patani

Finished document (Executive Documentation)

Review
Mr. Sagar Raval
Correctness and
(Asst. Manager Electrical)
Completeness

Review
Mr. Deepak Darjee
Correctness and
(Manager Production)
Completeness

Approval
Mr. Alpesh Mistry
Correctness and
(Vice President Operations)
Completeness

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MODEL NO: NKEW-200
WASHING MACHINE

VERSION HISTORY
VERSION EFFECTIVE DATE DESCRIPTION

00 NEW DOCUMENT

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WASHING MACHINE

TABLE OF CONTENTS

1.0 OBJECTIVE ....................................................................................................................... 5

2.0 SCOPE ................................................................................................................................. 5
3.0 REFERENCES .................................................................................................................... 5
4.0 RESPONSIBILITIES ......................................................................................................... 6
4.1 CLIENT’S ....................................................................................................................... 6
4.2 MANUFACTURER’S .................................................................................................... 6
5.0 SYSTEM DESCRIPTION ................................................................................................. 7
6.0 SCHEMATIC DIAGRAM ................................................................................................. 8
7.0 HARDWARE SPECIFICATION ...................................................................................... 9
7.1 MECHANICAL HARDWARE SPECIFICATION ...................................................... 9
7.2 ELECTROMECHANICAL SPECIFICATION .......................................................... 10
8.0 PLC INPUT / OUTPUT SPECIFICATIONS ................................................................. 12
9.0 TECHNICAL SPECIFICATIONS .................................................................................. 14
10.0 SAFETY FEATURES, ALARMS & INTERLOCKS ................................................ 15
11.0 LOGICAL SECURITY SPECIFICATIONS .............................................................. 16
11.1 LOGIN AND PASSWORDS ........................................................................................ 16
12.0 UTILITY SPECIFICATIONS ..................................................................................... 17
13.0 RECOMMENDED SPARE PARTS LIST .................................................................. 18
14.0 CHANGE PARTS LIST ............................................................................................... 19
15.0 FAT PROCEDURE ...................................................................................................... 20
16.0 REPORT APPROVAL ................................................................................................. 21
17.0 ABBREVIATION ......................................................................................................... 22

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MODEL NO: NKEW-200
WASHING MACHINE

1.0 OBJECTIVE

This document summarizes the Design Qualification of Automatic External Vial Washing Machine that
will be installed at the customer.

The purpose of the Design Qualification (DQ) is to provide the specifications and operation requirements of
the equipment on the basis of which it is designed. It is used to specify the requirements for the Installation
Qualification of the equipment.

2.0 SCOPE

This DQ is applicable to Automatic External Vial Washing Machine which will be used for wash the
outer surface of Vials, cleaned and dries it perfectly.

The system boundary is defined as including the Automatic External Vial Washing Machine, it will
define the responsibilities, acceptance criteria, basis of design, technical specifications and list of major
bought out parts, utility requirements, safety & cGMP features and documentation requirements.

3.0 REFERENCES

User requirement specification (URS) given by customer.

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4.0 RESPONSIBILITIES

4.1 CLIENT’S
 For providing complete technical specifications for design along with Purchase Order.
 To qualify equipment along with manufacturer.

4.2 MANUFACTURER’S
 To manufacture and supply the equipment incorporating all the specifications as per purchase
order and requirement.
 To assist client for successful installation & commissioning at the site.
 To design, engineer and provide the complete technical details of the equipment pertaining to
its design qualification viz.
 Machine overview.
 Provide GA drawing and P & ID.
 Specification of the sub-components/ bought out items, their make, model, quantity.
 Details of Utilities.
 Material of construction of components
 System description.

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5.0 SYSTEM DESCRIPTION

The External Vial Washing Machine is designed to wash the outer surfaces of round shaped Vials. This
machine washes the outer sides of Vials and eliminates the particles that are formed on the vials which are
previously filled and sealed. From the Infeed Turn Table, the Vials are fed into the External Washing
Machine through Conveyor. The Machine consists of Conveyors on which the vials are properly feeded
and transported for the washing operation. This machine having two conveyors for washing. Each
conveyor having a two manifold of water sprays having eight nozzles of each manifold for external
washing of vials & machine also having a facility for bottom washing of vials. Water jet is designed in
such a way that water will not interrupt into the aluminum. Seal cap. After washing of vials, each conveyor
having four nos. of air knifes for drying of washed vials. At the end of conveyors, there is a one dead
bridge having an eight nos. of small air nozzles for bottom drying. Once the vials washed by water nozzles
& dried by air knifes, they are guided to the out feed vial collection tray. The used water gets drained into
the drain line which is just below the conveyor. The Machine is fully controlled through the PLC system. If
there is water pressure or air pressure is low, machine stop & gives an alarm on display.

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6.0 SCHEMATIC DIAGRAM

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7.0 HARDWARE SPECIFICATION

Note: The identifiers/tag numbers for the major components will be listed during the qualification of the
equipment.

7.1 MECHANICAL HARDWARE SPECIFICATION

SR. NO. PART NAME / COMPONENT MOC / SEPCIFICATION

1. Machine frame structure S.S. Pipe Structure
2. Door Set S.S 304
3. Conveyor Guide S.S 304
4. Conveyor Belt Delrin
5. Bucket S.S.304
6. Nozzle S.S.316L
7. Conveyor Side Plate S.S 304
8. Dead Plate Delrin
9. Spray Chamber For Nozzle S.S.316L

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WASHING MACHINE

7.2 ELECTROMECHANICAL SPECIFICATION

SR.
ITEM MAKE MODEL SPECIFICATION
NO.
1. MOTOR (CONVEYOR) BONFIGLIOLI BN56B4 0.09KW,1350RPM.
2. GEAR BOX (CONVEYOR) BONFIGLIOLI VF30F1 60 P56B5B3 RATIO-60:1
3. MOTOR (INFEED TURN BONFIGLIOLI BN71B4 0.37KW,1370RPM.
TABLE)
4. GEAR BOX (INFEED TURN BONFIGLIOLI W63UFC1 100 P71B5B3 RATIO-100:1
TABLE)
5. MOTOR (PRESSING BELT) PANASONIC M9MX40G4YGA 40WATT,1350RPM.
6. GEAR BOX (PRESSING PANASONIC MX9G30B RATIO-30:1
BELT)
7. BLOWER SABAR IEC 60034 2.2 KW,2840RPM
8. AC DRIVE (CONVEYOR) ALLEN BRADLEY 22FD1P5N103 0.5HP,3PH TO 3PH.
9. AC DRIVE (INFEED TURN ALLEN BRADLEY 22FA2P5N103 0.5HP,1PH TO 3PH.
TABLE)
10. AC DRIVE (PRESSING ALLEN BRADLEY 22FA2P5N103 0.5HP,1PH TO 3PH.
BELT)
11. MODE BUS MODULE ALLEN BRADLEY 1763NC01 24VDC
WITH 485
12. PLC ALLEN BRADLEY 1766L32BXB 24VDC
13. ANALOG INPUT MODULE ALLEN BRADLEY 1762IF4 24VDC
14. ETHERNET SWITCH ALLEN BRADLEY 1783-US5T NA
15. HMI ALLEN BRADLEY 2711P-T6C20D8 24VDC
16. MCB (MAIN) HAGER NC410N C10
17. MCB (INFEED TURN HAGER NC206N C6
TABLE)
18. MCB (PRESSING BELT) HAGER NC206N C6
19. MCB (SMPS) HAGER NC206N C6
20. MCB (24 VDC SUPPLY) HAGER NC204N C4
21. CONTACTOR (MAIN) SCHNEIDER LC1D18 NA
22. ADDEN BLOCK SCHNEIDER LADN11 NA
23. CONTACTOR (BLOWER) SCHNEIDER LC1D09 NA
24. OVER LOAD RELAY SCHNEIDER LRD14 7 TO 10AMP.
(BLOWER)

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SR.
ITEM MAKE MODEL SPECIFICATION
NO.
25. RELAY CARD(8 PHOENIX PC24D04-CNB NA
CHANNEL)
26. SSR UNISON 807 PMDD 100 08 01 8AMP
27. SMPS OMRON S8VK-C06024 2.5AMP.24VDC
28. TRANSFORMER KAMO CORE 150VA. 250/24VAC
29. PRESSURE KELLER PA-21Y/22-2155-142 0-10BAR
TRANSMITTER (AIR-1)
30. PRESSURE KELLER PA-21Y/22-2155-142 0-10BAR
TRANSMITTER (AIR-2)
31. PRESSURE KELLER PA-21Y/22-2155-142 0-6BAR
TRANSMITTER (WATER)
32. SENSOR FOR NO VIAL LEUZE PRK3B/6.22 10 TO 30 VDC
VALVE ON/OFF TRACK 1
&2
33. SENSOR FOR VIAL PANASONIC CX-441-P 12 TO 24 VDC
COUNTING TRACK 1 & 2
34. PROXY FOR DOOR SICK IME12-04 BPS-ZW2S 10 TO 30 VDC
INTERLOCK TRACK 1 & 2
35. ACTUATOR SCHNEIDER NA BLACK
36. PUSH BUTTON (START) SCHNEIDER NA GREEN
37. PUSH BUTTON (STOP) SCHNEIDER NA RED
38. EMERGENCY STOP SCHNEIDER NA RED
39. SOLENOID VALVE (AIR ASCO NUMATICS WPX8210C088V-26885 0 TO 5BAR,10WATTS
TRACK-1)

40. SOLENOID VALVE ASCO NUMATICS WPX8210C088V-26885 0 TO 5BAR,10WATTS

(WATER TRACK-1)
41. SOLENOID VALVE (AIR ASCO NUMATICS WPX8210C088V-26885 0 TO 5BAR,10WATTS
TRACK-2)
42. SOLENOID VALVE ASCO NUMATICS WPX8210C088V-26885 0 TO 5BAR,10WATTS
(WATER TRACK-2)

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8.0 PLC INPUT / OUTPUT SPECIFICATIONS

PLC INPUT SPECIFICATIONS

SR. NO. ADDRESS DESCRIPTION
1. X0 (IN0) SENSOR FOR NO VIAL VALVE ON/OFF TRACK-1
2. X1 (IN1) SENSOR FOR NO VIAL VALVE ON/OFF TRACK-2
3. X2 (IN2) PROXY FOR DOOR OPEN TRACK-1
4. X3 (IN3) PROXY FOR DOOR OPEN TRACK-2
5. X4 (IN4) SPARE
6. X5 (IN5) SPARE
7. X6 (IN6) INCHING PUSH BUTTON
8. X7 (IN7) BLOWER TRIP
9. X8 (IN8) SENSOR FOR VIAL COUNTING TRACK-1
10. X9 (IN9) POWER FAILURE
11. X10 (IN10) SENSOR FOR VIAL COUNTING TRACK-2
12. X11 (IN11) SPARE
13. X12 (IN12) EMERGENCY STOP
14. X13 (IN13) SPARE
15. X14 (IN14) SPARE
16. X15 (IN15) AUTO START PUSH BUTTON
17. X16 (IN16) AUTO STOP PUSH BUTTON
18. X17 (IN17) SPARE
19. X18 (IN18) SPARE
20. X19 (IN19) SPARE

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PLC OUTPUT SPECIFICATIONS

SR. NO. ADDRESS DESCRIPTION

1. Y0 (OUT 0) AIR SOLENOID VALVE TRACK-1
2. Y1 (OUT 1) WATER SOLENOID VALVE TRACK-1
3. Y2 (OUT 2) CONVEYOR MOTOR
4. Y3 (OUT 3) SPARE
5. Y4 (OUT 4) INFEED TURN TABLE MOTOR
6. Y5 (OUT 5) PRESSING BELT MOTOR
7. Y6 (OUT 6) SPARE
8. Y7 (OUT 7) BLOWER MOTOR
9. Y8 (OUT 8) SPARE
10. Y9 (OUT 9) HOOTER
11. Y10 (OUT 10) AIR SOLENOID VALVE TRACK-2
12. Y11 (OUT 11) WATER SOLENOID VALVE TRACK-2

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WASHING MACHINE

9.0 TECHNICAL SPECIFICATIONS

9.1 BASIC MACHINE

PARAMETER DESCRIPTION

Basic Unit Suitable for 5ml to 30ml Vial With water & Air

9.2 OUTPUT SPEED

PARAMETER DESCRIPTION
150 Vials/ min. for 2ml vial
Output Speed
200 To 250 Vials/ min. for 5ml & 10ml vial

9.3 WASHING OPERATION

PARAMETER DESCRIPTION

Washing Operation Two Track

9.4 OPERATION
PARAMETER DESCRIPTION

Operation Machine Operation through PLC

9.5 TURN TABLE

PARAMETER DESCRIPTION

Turn Table In feed Turn Table of Ø36"

9.6 OTHER FEATURES

PARAMETER DESCRIPTION

Contact Parts All contact parts are made from SS316L

Cabinet Acrylic Cabinet

Guide Adjustment, water Flow & Jet Adjustment and Air Jet & Flow
User Friendly
adjustment All parts easily removable.

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10.0 SAFETY FEATURES, ALARMS & INTERLOCKS

The equipment shall be provided with safety features as listed below.

SR.
FEATURE SPECIFIED
NO.

1. AIR PRESSURE LOW TRACK-1 MACHINE STOP

2. AIR PRESSURE LOW TRACK-2 MACHINE STOP

3. BLOWER TRIP MACHINE STOP

4. CONVEYOR DRIVE FAULTED MACHINE STOP

5. DOOR OPEN TRACK 2 MACHINE STOP

6. DOOR OPEN TRACK 1 MACHINE STOP

7. EMERGENCY STOP PRESSED MACHINE STOP

8. NO VIAL NO AIR & WATER TRACK 1 AIR & WATER VALVE OFF

9. NO VIAL NO AIR & WATER TRACK 2 AIR & WATER VALVE OFF

10. PRESSING BELT DRIVE FAULTED MACHINE STOP

11. INFEED TURN TABLE DRIVE FAULTED MACHINE STOP

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11.0 LOGICAL SECURITY SPECIFICATIONS

11.1 LOGIN AND PASSWORDS

The Programmable Logic Controller of the Automatic External Vial Washing Machine can be accessed
using authorized password.

SR. NO. USER GROUP NAME RIGHTS & AUTHORIZATION

1 Administrator All rights

Change in the process parameters, Operation, Recipe,

2 Manager

Operation, Variable parameters change, Recipe download, alarm

3 Supervisor
ack.

4 Maintenance I/O list

5 Operator Operation, Alarm acknowledge

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12.0 UTILITY SPECIFICATIONS

The electrical specifications where the machine is stored should be within the ranges specified by the
hardware manufacturer.

PARAMETER DESCRIPTION

Electrical Power Supply 415V(±10%), 3 Phase, 50Hz, 4 Wire

Power Requirement 3 kW / 4 HP

Compressed Air 15 CFM @ 6 Bar Pressure

Water Consumption 210 Liters /Hours.

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13.0 RECOMMENDED SPARE PARTS LIST

SR. NO. PARTS NAME QTY.

1 TIMING BELT 01 NO.
2 SOLENOID VALVE 01 NO.
3 TC CLAMP GASKET 01 NO.
4 DOOR PISTON 01 NO.
8 RELAY CARD 01 NO.
9 SMPS 01 NO.
10 SOLENOID COIL ( WATER) 01 NO.
11 PRESSURE SWITCH (AIR) 01 NO.
12 PRESSURE SWITCH (WATER) 01 NO.
13 NO VIAL SENSOR 01 NO.
14 GUARD INT. PROXY 01 NO.
15 PLC TO HMI COMM. CABLE 01 NO.
16 BLACK ACTUATOR 01 NO.
17 EMERGENCY STOP 01 NO.
18 INCHING BUSH BUTTON 01 NO.
19 PUSH BUTTON 01 NO.

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14.0 CHANGE PARTS LIST

SR. NO. DESCRIPTION QTY.

1.

2.

3.

4.

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15.0 FAT PROCEDURE

Factory Acceptance Test Procedure shall be as follows:

After the completion of erection work of the machine, customer shall be informed to perform the factory
acceptance test (FAT).

Customer shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT
document as per the details given below:

1. Test criteria
2. Design Verification Check list
3. Deficiency & Corrective Action report
4. Pre-installation requirements.
5. Final report

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16.0 REPORT APPROVAL

This Design Qualification Protocol has been completed, reviewed and found acceptable. Any deviations
found have been reconciled and this system operates and performs properly in accordance with design
specifications. This Design Qualification Protocol has been reviewed and approved by the individuals
listed below.

APPROVAL TABLE (CLIENT)

SIGNS FOR ROLE NAME DATE SIGNATURE

REVIEWED BY

APPROVED BY

CONCLUSION FOR DESIGN QUALIFICATION

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WASHING MACHINE

17.0 ABBREVIATION

The following abbreviations are used in this document.

ABBREVIATION DEFINITIONS
cGMP Current Good Manufacturing Practice
GEP Good Engineering Practices
VFD Variable Frequency Drive
Hz Hertz
KW Kilo Watt
HP Horse Power
SS Stainless Steel
RPM Revolution per minute
MOC Material of Construction
No Number
IQ Installation Qualification Protocol
OQ Operation Qualification Protocol
FAT Factory Acceptance Test
MM Millimeter
ML Milliliter
PW Purified Water
WFI Water for Injection

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