Design Qualification ( DQ ) page1 / 62

Document No.: Version No.: Customer Ref. No.: Date of issue.:

QAC-FT-25 1.00 PO.No. : 4512146312 28.12.2015

Model: Coater (SC500)

Batch No : SC071

Equipment Sr. No. : 071S

Document issued by: M/s ACG Pharma Technologies Pvt. Ltd, Shirwal

Name Date Signature

Mr Jayant Jadhav
28.12.2015
(Officer Documentation)

Document checked by: M/s ACG Pharma Technologies Pvt. Ltd, Shirwal

Name Date Signature

Mr.Sandeep Yadav
28.12.2015
(Sr Engineer QAC )

Document approved by : M/s ACG Pharma Technologies Pvt. Ltd,Shirwal

Name Date Signature

Mr.Pinakin Mokashi
28.12.2015
(DGM, QA )

Document approved by : M/s Sanofi India Limited., Ankleshwar

Name Date Signature

Document No: QAC-FT-25 ( Batch No. : SC071 )

 Design Qualification ( DQ ) Version: 1.0

Change history

Version Reference Description, Ref. to Clauses or Chapters/Sections

Page No.

1.0 -- First official Issue, Date : 28.12.2015

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 Design Qualification ( DQ ) Version: 1.0

Index

1 Objective:..................................................................................................................6
2 Scope: ......................................................................................................................6
3 Responsibilities: ........................................................................................................7
4 User Requirements Specification (URS): ..................................................................8
5 Machine Description: ..............................................................................................14
5.1 Coating Equipment Description...............................................................................14
6 Control System .......................................................................................................16
6.1 PLC Description: .....................................................................................................17
6.2 Digital Outputs from PLC: .......................................................................................19
6.3 Digital Inputs from PLC ...........................................................................................20
6.4 Analog Inputs cards ................................................................................................21
6.5 Analog Output cards ...............................................................................................21
7 Technical Specifications Of Components & Sub-Components Used / Bought Outs 22
7.1 Inlet Air Handling unit..............................................................................................22
7.1.1 AHU Casing ............................................................................................................22
7.1.2 Pre Filter (EU4), Qty-2 Nos. ....................................................................................22
7.1.3 Differential Pressure Gauge Across Pre (EU4) Filter (Magnehelic Gauge)..............22
7.1.4 DH Coil ( Chilled Water Coil )..................................................................................23
7.1.5 Dehumidification Control Valve ...............................................................................23
7.1.6 Dehumidification Temperature Sensor ....................................................................23
7.1.7 Blower ....................................................................................................................23
7.1.8 Blower Motor ..........................................................................................................24
7.1.9 Steam Coil ..............................................................................................................24
7.1.10 Steam On/Off Valve ...............................................................................................24
7.1.11 Auto drain valve for steam condensate ...................................................................24
7.1.12 Proportional Valve ..................................................................................................24
7.1.13 Fine Filter (EU7), Qty – 2 Nos. ................................................................................25
7.1.14 Differential Pressure Transmitter across Fine ( EU7 ) Filter ....................................25
7.1.15 Differential Pressure Gauge across Fine (EU7) Filter (Magnehelic Gauge )............25
7.1.16 HEPA Filter (EU13), Qty – 2 Nos. ...........................................................................25
7.1.17 Differential Pressure Transmitter across HEPA ( EU13 ) Filter................................26
7.1.18 Limit Switch for AHU Doors.....................................................................................26
7.2 Inlet Air Flow Sensor...............................................................................................27
7.3 Relative Humidity Sensor ( RH ) ............................................................................27

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7.4 Inlet Temperature Sensor .......................................................................................27

7.5 Inlet Air Flap (On/Off) ..............................................................................................27
7.6 Structure assembly .................................................................................................28
7.7 Coater Housing .......................................................................................................29
7.7.1 Side door assembly ................................................................................................29
7.7.2 Proximity Switches..................................................................................................29
7.7.3 Safety Valve (Over Pressure ) ................................................................................29
7.7.4 Safety Valve ( Under Pressure ) .............................................................................29
7.7.5 Lip Seal, pan/back wall ...........................................................................................29
7.7.6 WIP Nozzles on Roof for outside Pan (Flat Jet Sprinkler), Qty -9 Nos. ...................30
7.7.7 Level Float Switch( WIP water discharge flap) ........................................................30
7.7.8 Over Flow Drain Valve ............................................................................................30
7.7.9 WIP water, discharge flap .......................................................................................30
7.8 Coating Pan Assembly............................................................................................31
7.8.1 Differential Pressure Transmitter Across Pan .........................................................31
7.8.2 Mixing baffles (Standard ) - 05 Nos .........................................................................31
7.8.3 Gear Box ................................................................................................................31
7.8.4 Pan Motor ...............................................................................................................31
7.8.5 Pan Drive Bearing (Sieve bearing) .........................................................................32
7.9 Top Railing assembly..............................................................................................33
7.9.1 Top enclosure assembly .........................................................................................33
7.9.2 Front Arm Assembly ...............................................................................................33
7.9.3 Front Door with ‘D’ type glass opening assembly ....................................................33
7.9.4 Film Coating Arm Assembly (Colapsible type) ........................................................33
7.9.5 Spray Nozzles (X – One ), Qty - 5 Nos...................................................................33
7.9.6 WIP troll ball on spray arm for inside Pan ...............................................................34
7.9.7 Manifold Assembly for Spray Liquid ........................................................................34
7.9.8 Spray Pump ............................................................................................................34
7.9.9 Spray Pump Motor ..................................................................................................34
7.9.10 Discharge Assembly: (Unloading device ) ...............................................................35
7.10 Exhaust System ......................................................................................................36
7.10.1 Exhaust Shoe assembly .........................................................................................36
7.10.2 Exhaust Air Flap .....................................................................................................36
7.10.3 Exhaust Temperature Sensor .................................................................................36
7.10.4 Wet Scrubber ( FRP Lining) Explosion Proof ..........................................................37
7.10.5 Exhaust Blower assembly .......................................................................................38

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7.11 Booster Pump Assembly.........................................................................................39

7.12 Solution Holding Tank : 01No. ................................................................................40
7.13 PLC ........................................................................................................................41
7.13.1 Analog Input Card ( Analog to Digital ), Qty : 2 Nos ................................................41
7.13.2 Analog Output Card (Digital to Analog) – 1 No........................................................41
7.13.3 Temperature Transmitter, Qty - 3 Nos. ...................................................................41
7.13.4 Pressure Transmitter, Qty - 3 Nos...........................................................................42
7.13.5 I to P Converter , Qty : 2 Nos. .................................................................................42
7.13.6 I to P Converter , Qty : 2 Nos. .................................................................................42
7.13.7 Air Control System ..................................................................................................42
7.14 PC Control ..............................................................................................................43
7.15 Printer .....................................................................................................................43
7.16 ACVF Drive.............................................................................................................43
8 Details Of Utilities:- .................................................................................................44
8.1 Electrical .................................................................................................................44
8.2 Compressed Air ......................................................................................................44
8.3 Steam consumption ................................................................................................44
8.4 Chilled water consumption ......................................................................................44
9 Identification Of Component For Calibration ...........................................................45
10 Material Of Construction .........................................................................................46
11 P&I Diagram For Reference & Approval..................................................................47
12 Equipment Orientation With Room Lay Out: ...........................................................48
13 Safety Features And Alarms: ..................................................................................49
13.1 Sealing System.......................................................................................................49
13.2 Alarm / Fault Administration ....................................................................................49
14 List Of Alarms: ........................................................................................................50
15 FAT Procedure: ......................................................................................................60
16 Appendix.................................................................................................................61
16.1 List Of Abbreviations...............................................................................................61
16.2 Reference Documents ............................................................................................62

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 Design Qualification ( DQ ) Version: 1.0

1 Objective:

To design, engineer and supply the Tablet Coating Equipment as per cGMP and GEP
guidelines and to provide assurance that the machine is manufactured as per the URS
and it complies with the Scope of Supply.

To prove that each operation proceeds as per the design specification and the
tolerances prescribed there in the document, are the same at utmost transparency.
Validation procedure is set for complete satisfaction of the customer & building
confidence of the user about the machine.

2 Scope:
The scope of this qualification document is limited to the Design Qualification of Tablet
Coating Equipment .

The scope of this document includes all of the operating functions, control functions, &
alarm of the Tablet Coating Equipment

In addition to an introduction to the machine functionality, this document provides a

detailed description for each identifiable separate function performed by the machine.

Qualification of support utilities is not within the scope of this qualification document. For
the support of utilities, details are given regarding total requirement of electric power,
compressed air, steam and chilled water.

The Equipment shall be used for Film Coating of different Tablets. The Equipment shall
operate under dust free environment and conditions as per the cGMP requirements.

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3 Responsibilities:
A. Client:

i. To provide the URS for the Equipment.

ii. To perform the Factory Acceptance Test (FAT)

B. Manufacturer:

To design and provide the complete technical details of the Equipment

pertaining its ‘Design Qualification’:-

i. Equipment Orientation with layout

ii. P&ID drawing

iii. Details of Utilities

iv. Identification of Calibrated Instruments

v. Material of Construction of Product Contact Parts.

vi. Brief process description

vii. Safety features and alarms

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4 User Requirements Specification (URS):

DESCRIPTION SPECIFICATIONS

Equipment Tablet Coating Equipment

Application Tablet Coating : Film Coating

Model Smart Coater SC 500

Standard Baffles
Volumetric
Capacity
Max. Min.

500 Litres 280 Litres

As per PO No. 4512146312 Dated : 14.10.2015

Reference [Including all Standard Accessories as per following
Scope of Supply]

Adequate safety features for men and material shall be provided

along with the Equipment flameproof motors (For Pan Gearbox &
Peristaltic Pump only)

The equipment should be a cGMP model, in terms of surface finish,

Safety features absence of sharp corners, cleanability, assembling and dismantling of
components and control system for its intended use. Separation of
service parts (e.g. drives) from processing zone, to enhance the
cGMP. Ease of cleanability.
Exterior easy to clean, disinfect and non-corrosive.

Material of All Product Contact Parts are manufactured from SS 316/316L

construction Material & all other product non contact parts are of SS 304.

Electrical system The electrical system of the equipment shall be housed as per the
cGMP and GEP standard, with adequate safety.
Electro Pneumatic panel to be installed in Technical Area.

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DESCRIPTION SPECIFICATIONS

Control system The Equipment shall be controlled through PC based system.

Calibration Calibration certificates to be provided. Test certificates / calibration

charts of sensors & control instruments to be provided.

Qualifications/ The manufacturer shall complete and provide the documents pertaining
Documentation to Design, Installation & Operation Qualification and detail functional
specifications including control system with screen design of operating
terminal.
Alarms & Interlocks.
Information on purchased/bought-out parts.
Circuits & interlocks details.
Operating manual
Preventive maintenance schedules
Safety precautions
Test Certificates of Bough-out parts
Instruments calibration certificates.

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DESCRIPTION SPECIFICATIONS

1. Inlet Air Handling Unit Consist of :-

a) AHU Body : Two Tier Constructions. Double Walled Insulated. Inside –

SS 304, Outside – GI Pre-coated.
b) Pre-Filters (EU4) having Efficiency of 95% down to 10µm
c) Differential Pressure Gauge across pre-filters for local indication.
d) Dehumidification Coil
e) Moisture Arrester at Dehumidification Coil
f) Dehumidification Control Valve
g) Dehumidification Temperature Sensor
h) Inlet Air Blower standard having flameproof motor
i) Steam Coil
j) Steam Control Valve
k) Auto drain valve for steam condensate
l) Fine Filters (EU7) having Efficiency of 99% down to 3µm
m) Differential Pressure Gauge across fine filters for local indication.
n) HEPA Filters having Efficiency of 99.997% down to 0.3µm
o) Differential Pressure Transmitter across HEPA Filters.
p) Provision for PAO Testing at HEPA Filter Section.
q) Limit Switches for AHU doors

2. Inlet Air Ducting Assembly from AHU to Coater Housing

consists of :-

a) Air Flow Sensor

b) Relative Humidity Sensor ( ABS )
c) Inlet Air Temperature Sensor
d) Inlet Air Flap (On Off Type Actuator)
e) Limit switches on Inlet Air control flap

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DESCRIPTION SPECIFICATIONS

3. Coater Housing consists of:-

a) Main Housing : MOC SS 316L Inside Except Front Sheet

(i.e. SS304)
b) Side Doors ( Sliding Type Doors) MOC Inside SS 316L, Outside SS304
c) Front Door Assembly, MOC SS 316L
d) Sampling Assembly (With ‘D’ type openable door with sampling scoop)
e) Proxy switches for doors
f) Flameproof Lamp Illumination from top of the housing.
g) WIP Washing flat jet nozzles from Inside of coater top housing.
h) Safety Valves (Under Pressure and Over Pressure)
i) Lip seal
j) Exhaust Shoe Assembly

4. Coater Pan Consists of:-

a) Coating Pan (MOC- SS316L)

b) Gear Box
c) Pan Motor ( Flameproof)
d) Pan Drive Bearing
e) Mixing Baffles ( MOC- SS316L)

5. Spray Arm Assembly consists of:-

a) Film Coating Arm Assembly

b) WIP Troll Ball
c) Front Arm Assembly
d) Top Railing Assembly
e) Top Enclosure

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DESCRIPTION SPECIFICATIONS

6. Spraying System ( Film Coating )

a) Spray Nozzles
b) Standard Flameproof (Peristaltic) Spray Pump
c) Spraying Tubes ( Silicone Food Grade)

7. WIP System

a) WIP ( Booster Pump)

b) Troll ball for Inside drum cleaning
c) Flat Jet nozzles for outside drum cleaning and Inside Housing cleaning.

8. Exhaust Air System

a) Exhaust Air Temperature Sensor

b) Exhaust Air Flap (On Off Type Actuator)
c) Limit switches on exhaust control flap
d) Exhaust Blower having flameproof motor
e) Sound Relaxation Silencer at outlet of blower

9. Control System

a) Control panel of the tablet coating machine will be equipped with

programmable logic controller and touch screen HMI.
b) IPC ( Contec make) based system should provided with ACVF drive
c) Weighing balance integration
d) 0.2 µm Air Filter Assembly ( Pall make)

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DESCRIPTION SPECIFICATIONS

10. Additional Accessories

a) Wet Scrubber
b) Solution Holding Tank – 200 Litre ( Heating type – plain, Pneumatic
stirrer, Manual ball valve, PU wheels, ) – 1 No.
c) Solution holding tank with breakes on wheels
d) EU4 & EU7 Filters water washable.
e) Drain valve in inlet steam operated through PLC
f) PVC pipe and fitting for pneumatic and electrical
g) DP Transmitter for EU7 Filter
h) MS Stand for AHU, Blower & Panel
i) Additional chamber for HEPA

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5 Machine Description:
5.1 Coating Equipment Description
Coaters are used mainly in the pharmaceuticals industry for film coating tablets. The
machine requires special knowledge and skills to operate. The Coater have been
constructed and built according to the state of art technology and safety regulations. It is
nevertheless possible that the operator or a third person may be exposed to danger to
life. If the equipment is improperly used and operated, it will be damaged to the coater
and other accessories.
The tablets to be coated are loaded into the Pan of the SC 500
The Pan manufactured by two cones and a perforation sheet having Ø 3mm holes.
There is central opening at the front and back cone is welded with centre sheet with back
flange assembly which has been assembled with Pan bearing & Gear Assly. The air is
used for drying/heating
The air is used for drying/heating and filtered through 10 micron pre air filters, 3 micron
fine filters.
Hot, filtered air is passed at high velocity from the inlet of the Coater through the Tablets.
Due to the high temp of the air, the tablets are heated. The Pan is rotated for mixing of
the tablets.
The spraying of solution is done through the spray nozzles. The solution is pumped
through the peristaltic pump. The processed air inside the pan is taken out with the help
of exhaust blower. The pan to arrest dust and chemical particulates entrapped in
exhaust air, before escaping to atmosphere.

The machine divides in following sections:

Inlet air handling unit system.

Coater (Main body, Pan & pan drive, mixing baffles, Inlet & exhaust control flaps)

Spraying System

Wet Scrubber

Inlet Air Handling Unit System

Air handling unit consists of 10µm Pre filter (EU4) section, Steam coil, 3µm Fine filter
(EU7) section, 0.3µm HEPA filter (EU13) section with ∆ P port and airflow and
temperature measuring devices. Inlet Air Handling Unit receives the air form the
environment and processes the inlet air and controls the inlet airflow.

Coater Main Unit:

It consists of main body, Pan & Pan Drive, Mixing baffles, Inlet, Exhaust & bypass flaps.
The tablets are heated up by the inlet air coming from AHU. The tablets are rotated by
the Pan and mixing takes place. Meanwhile the spraying is done by the spray guns and
the coating of tablets takes place.

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Spraying system:
It consists of peristaltic spray pump, spray nozzle mounted on the spray nozzle header,
solution tank. Main function of the spraying system is to spray the liquid uniformly over
the rotating tablets. For the coating application the spraying is done inside the coating
pan at the right angles of the tablets bed.

Exhaust Air Unit System:

It consists of an exhaust fan and an air temperature measuring device. The Exhaust fan
draws the process air from the Pan. The exhaust blower is responsible for creating
negative pressure in the coating pan, so that there should be no turbulence in the pan &
the Process air will be extracted through the tablet bed. Sound relaxation silencer will be
provided to reduce the sound.

Wet Scrubber:
The Scrubber consists of tank containing water capacity is 200 Ltrs. The process air
comes in the venturi of the scrubber. The pump is connected at the bottom of the
scrubber tank which is Pumping the water in the venturi. The scrubbing process takes
place in the venturi and the air is drawn through the scrubber by exhaust blower.

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6 Control System
The control panel is made of ms powder coated along with Mitsubishi PLC & Operating
panel made of SS304 based touch screen control HMI Contec make based touch screen
control & HP Printer.
All the transmitters are to be mounted inside the panel.
All interfacing tubing/cables will be passed through SS conduits in manufacturing area.
All the major parameters like flap, temperature, atm air pressure, process time, machine
setting will be monitored through control panel.
One panic push button (On Coater Housing) for switching off the machine in emergency
will be provided. One Emergency stop push button for stopping the machine on
operating panel.
Atomising air pressure adjustment through PLC.
Four level password protections are provided (for operator, supervisor, recipe &
maintenance).
1. Operator: This level password is normally to access parameter which operator needs
to change during batch processing.
2. Supervisor: Set parameter, which have direct influence as process like Spray rate,
Product temp, Inlet temp. are categorized under supervisor level password.
3. Recipe: This level is for reference parameter for each product. This
Parameter are standardise parameter after validation hence categorized under this level.
4. Maintenance: Certain parameters, which are related to equipment setting from
engineering point of view. This need not be change for day to day operation of
machine. for eg. P.I.D setting for Inlet Temp
A. The following functions will be operated through the PLC screen:
i. Process On / Off
ii. Spray Test, Spray On/Off
iii. Inlet air temp. – set & actual with PID Loop
iv. Exhaust air temperature – set & actual
v. DP HEPA with Alarm Set
vi. Air Flow measurement in m/sec or CFM.
vii. Different Safety Alarms & interlock as per list
viii. Heater On / Off

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B. Printer will be provided to print the following data as a report.

i. Real time & date, Product Name , Batch Info,

ii. Set parameters (Inlet temp)

iii. Actual Parameters (Inlet, exhaust, Pan D.P., ATM Air)

iv. Air Velocity/Flow

v. Alarms and error messages

C. Pneumatic & Electrical Panel:-

Electro pneumatic panel is to be installed in service area.

Pressure sensor is located on Spray pump trolley and will detect the choking of
spray guns.

6.1 PLC Description:

The main function of a PLC is to translate the instructions into the digital or analogue
codes needed to operate the device or machine. PLC system collects data from field
instrumentation & displays the information on the operator station. The instruments are
connected to the system Equipment.

The collected data is utilised by the PLC for process control. The user interface, HMI,
assists the operator to supervise and control the process. Based on the displayed
information, the operator, by means of the user interface, provides commands to the
PLC.

The PLC then executes the operator instructions. A Mitsubishi Family FX3U PLC is
provided as the Central Processing Unit (CPU).

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The PLC system layout for the Smart Coater machine automation is as shown below:

⊗⊗⊗⊗⊗⊗⊗⊗⊗⊗⊗⊗⊗⊗
F X3 U-ENET-ADP

FX3 U-4DA-ADP

FX2N - 2 32IF
PLC-AO -001

PLC-AI-001

PLC-AI-002

PLC-IF-001
FX2N- 8AD

FX2N- 8AD
PLC-CPU-001
48 5 BD
PLC

FX3U- 64 M

MITSUBISHI

⊗⊗⊗⊗⊗⊗⊗⊗⊗⊗⊗⊗⊗

Contec
IPC

Contec
Monitor

HP : M251 n

The controller software generated, for the Smart Coater 500 machine automation has
been developed in ladder logic language Gx Works 2

The Operator Station screens have been developed using Scada Zenon, V 7.X.

Scada Software:-

a) Make : COPA DATA

b) Version : Zenon 7.X.
c) Application : Development – APT
d) Licence – In USB Dongle

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6.2 Digital Outputs from PLC:

Y0 Exhaust Blower On Y27 WIP – SV1 - Raw Water

Y1 Inlet Blower On Y30 WIP - SV2 - DM Water

Y2 Pan Motor On Y31 WIP - SV3 - Compressed Air

Y3 Spray Pump ON Y32 Spare

Y4 Spray Nozzle Needle Y33 Spare

Y5 Atomisation SV Y34 Spare

Y6 Inlet Flap Y35 Spare

Y7 Exhaust Flap Y36 Spare

Y10 Machine Lamp Y37 Spare

Y11 Heater - Steam SV

Y12 Steam/Auto Drain SV

Y13 Alarm / Buzzer

Y14 DP Valve – Inlet

Y15 DP Valve - Exhaust

Y16 Sugar Bypass SV (O)

Y17 Sugar SV (O)

Y20 M/C Washing - Drain Valve

Y21 Pattern Air SV

Y22 Spray Pump Reverse

Y23 Scrubber – Pump

Y24 Scrubber - Water SV

Y25 Scrubber - Drain SV

Y26 WIP – Pump

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6.3 Digital Inputs from PLC

X0 PAN RPM feedback - RPM X25 Exhaust flap Feedback

X1 Spare X26 Sugar Bypass Feedback (O)

X2 Inlet Blower Electrical X27 Scrubber - Pump electrical

X3 Spare X30 Scrubber - Water Pressure Low

X4 Pan Motor Electrical X31 Scrubber - Water Level Low

X5 Spare X32 WIP - Booster Pump Electrical

X6 Spray Pump Electrical X33 Spare

X7 Spare X34 Spare

X10 Electrical Supply Monitor X35 Spare

X11 RHS Door Open X36 Spare

X12 LHS Door Open X37 Spare

X13 Mains Power Failure

X14 Emergency Stop - BT1

X15 Exhaust Blower Electrical

X16 Spare

X17 Spare

X20 AHU Door Open

X21 Spray Arm Out

X22 Washing Water Level

X23 Washing Drain Valve ON

X24 Inlet flap Feedback

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6.4 Analog Inputs cards

Sr. No. Channel Description

Analog Input Card 1 : FX2N-8AD

1. Channel 1 Inlet Temperature

2. Channel 2 Exhaust Temperature

3. Channel 3 Air Flow Inlet

4. Channel 4 DP – Pan

5. Channel 5 DP – HEPA Inlet

6. Channel 6 Operating Air Pressure

7. Channel 7 Atomisation Air Pressure

8. Channel 8 Spare

Analog Input Card 2 : FX2N-8AD

1. Channel 1 Dehumidifiation temperature

2. Channel 2 RH – Inlet

3. Channel 3 Pattern Air Pressure

4. Channel 4 DP – EU7 Filter

5. Channel 5 Spare

6. Channel 6 Spare

7. Channel 7 Spare

8. Channel 8 Spare

6.5 Analog Output cards

Sr. No. Channel Description

Analog Outputs Card 1 : FX3U-4DA-ADP

1. Channel 1 Atomisation Air Press. Control

2. Channel 2 Heater Control - Steam Valve

3. Channel 3 Dehumidification Control

4. Channel 4 Pattern Air Control

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7 Technical Specifications Of Components & Sub-Components Used / Bought Outs

Sr.No. DESCRIPTION SPECIFICATIONS

7.1 Inlet Air Handling unit

Manufacturer Netfil Technik Pvt. Ltd.

7.1.1 AHU Casing

Inner Skin- MOC SS 304

Outer Skin – MOC GI pre coated

7.1.2 Pre Filter (EU4), Qty-2 Nos.

Manufacturer Netfil Technik Pvt. Ltd.

Size (610 x 610 x 75) mm

Filter - MOC Fire Retardant Glass Fiber

Capacity 1800 CFM

Operating Temp. 120 °C continuous

Filter Efficiency 95% down to 10 µm

Initial Pressure Drop 4.5mmWC

Final Pressure Drop 15mmWC

7.1.3 Differential Pressure Gauge Across Pre (EU4) Filter (Magnehelic Gauge)

Manufacturer Dwyer

Range 0-50 mmWC

Accuracy +/ - 2% FS

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Sr.No. DESCRIPTION SPECIFICATIONS

7.1.4 DH Coil ( Chilled Water Coil )

Manufacturer Netfil Technik Pvt. Ltd.

Capacity 6000 CMH

Size / No of Rows 40”(L) x 24”(H) / 8 Nos

MOC Tubes – Copper, Fins- Aluminium

Face Velocity ( FPM ) 563 FPM

Liquid Required Water 100%

Consumption 160.79 GPM

Sensible Heat 1,64,124.01 BTU/Hr

Total Heat 4,84,524.11 BTU/Hr

7.1.5 Dehumidification Control Valve

Manufacturer Micro Pneumatics

Size 2” (50NB)

Pneumatic Operated,
Type
3 Way Valve

7.1.6 Dehumidification Temperature Sensor

Manufacturer Radix

Type RTD PT 100

Material – Sensor Rod SS 316 L

Temperature Range 0 -150oC

Accuracy + 0.15 at 0 oC and 0.35 at 100 oC

7.1.7 Blower

Manufacturer GEBHARDT

Model PLUG RLO EVO 4550@ 42mm

Capacity 6000 m³/hr, 200mmWC

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Sr.No. DESCRIPTION SPECIFICATIONS

7.1.8 Blower Motor

Manufacturer CG Motors

Type Flame proof

Motor Power 11 kW/ 15 HP

Supply Power 3 Phase, Voltage 415±10% Volts

7.1.9 Steam Coil

Manufacturer Netfil Technik Pvt. Ltd.

Capacity 6000 CMH

Size of coil 40”(L) x 24”(H)

MOC SS304

No of Rows 6 Nos

Total Heat 750671.1 BTU/Hr

Steam Consumption 362 kg/hr

7.1.10 Steam On/Off Valve

Manufacturer Micro Pneumatics

Size 1 ½ ” (40NB)

Type Pneumatic Operated, Ball Valve

7.1.11 Auto drain valve for steam condensate

Manufacturer Micro Pneumatics

Size 1” (25NB)

7.1.12 Proportional Valve

Manufacturer Samson

Size 1 ½ ” (40NB)

Type Pneumatic Operated,

Proportional Valve

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Sr.No. DESCRIPTION SPECIFICATIONS

7.1.13 Fine Filter (EU7), Qty – 2 Nos.

Manufacturer Netfil Technik Pvt.Ltd.
Filter MOC Fire Retardant Glass Fiber
Size (610 x 610 x 200) mm
Capacity 1800 CFM
Filter Efficiency 99% down to 3 µm
Initial Pressure Drop 7 mmWC
Final Pressure Drop 20 mmWC
Operaing Temperature 120°C continuous

7.1.14 Differential Pressure Transmitter across Fine ( EU7 ) Filter

Manufacturer Dwyer
Model 616C-1
Applied for Fine filter
Pressure Range 0 - 750 Pa (0-3)”WC
Accuracy +/- 1% FS

7.1.15 Differential Pressure Gauge across Fine (EU7) Filter (Magnehelic Gauge )
Make Dwyer
Range 0 – 50 mmWC
Accuracy +2% FS

7.1.16 HEPA Filter (EU13), Qty – 2 Nos.

Manufacturer Netfil Technik Pvt.Ltd.
Filter MOC Sub Micronic Glass Fiber
Size (610 x 610 x 300) mm
Capacity 1800 CFM
Operating Temp. 120°C continuous
Filter Efficiency 99.997% down to 0.3 µm
Initial Pressure Drop 25mmWC
Final Pressure Drop 50mmWC

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 Design Qualification ( DQ ) Version: 1.0

Sr.No. DESCRIPTION SPECIFICATIONS

7.1.17 Differential Pressure Transmitter across HEPA ( EU13 ) Filter

Manufacturer Dwyer
Model 616C-2
Applied for HEPA filter
Pressure Range 0 - 1500 Pa (0-6)”WC
Accuracy +/- 1% FS

7.1.18 Limit Switch for AHU Doors

Manufacturer Teknic

Type Lever Type

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 Design Qualification ( DQ ) Version: 1.0

Sr.No. DESCRIPTION SPECIFICATIONS

7.2 Inlet Air Flow Sensor

Manufacturer Kimo

Model CP212-BO

Operating Range 0 – 20 m/s

Accuracy +/-0.5%

7.3 Relative Humidity Sensor ( RH )

Manufacturer Rotronic AG

Type XB32-X2P3I1PXXXX/01

Range 0-100% ( For RH )

Output 4-20mA

Accuracy +/- 1.0% RH & +/- 0.2 oC

7.4 Inlet Temperature Sensor

Manufacturer RADIX

Type RTD - PT 100

Sensor MOC SS 316 L

Temperature Range 0-150 oC

Accuracy + 0.15 at 0 oC and 0.35 at 100 oC

7.5 Inlet Air Flap (On/Off)

Manufacturer ACG Pharma Tech. Pvt. Ltd.

Housing – MOC Aluminium

Flap Disc – MOC SS 304

Drive Shaft – MOC SS 304

Sealing – MOC Silicone

Drive Pneumatic Actuator, Rotex make

Model ECF100

Limit Switch DXLW1A2-4R

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Sr.No. DESCRIPTION SPECIFICATIONS

7.6 Structure assembly

Manufacture ACG Pharma Tech. Pvt. Ltd.

MOC M.S. ( IS1239:2004 / IS:2062)

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 Design Qualification ( DQ ) Version: 1.0

Sr.No. DESCRIPTION SPECIFICATIONS

7.7 Coater Housing

Manufacturer ACG Pharma Tech. Pvt. Ltd.

Surface finish Matt Finishing ( Ra Max. 1.32µm)

Pan illumination position Top side of coater housing

Drain Bottom side of housing

7.7.1 Side door assembly

Manufacturer ACG Pharma Tech. Pvt. Ltd.

MOC (Inside/Outside ) SS316L/SS 304

Type Sliding door

7.7.2 Proximity Switches

Manufacturer P&F

NJ5-18GM-N- For Front, Left &

Type Right Door
NBB2-8GM30-E2– For Drum RPM

7.7.3 Safety Valve (Over Pressure )

Manufacture Rotex

Size 50 NB

7.7.4 Safety Valve ( Under Pressure )

Manufacturer Rotex

Size 25 NB

7.7.5 Lip Seal, pan/back wall

Manufacturer Western Rubber

MOC Silicone Food Grade

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Sr.No. DESCRIPTION SPECIFICATIONS

7.7.6 WIP Nozzles on Roof for outside Pan (Flat Jet Sprinkler), Qty -9 Nos.

Manufacturer Siddharth

MOC SS 316L

Capacity 5 lpm

7.7.7 Level Float Switch( WIP water discharge flap)

Manufacturer P&F

Type LVL-A1-G1S-E5PG-CG

7.7.8 Over Flow Drain Valve

Manufacturer ACG Pharma Tech. Pvt. Ltd.

Size 2”

Type “Y” Type Threaded

7.7.9 WIP water, discharge flap

Manufacturer Micro Pneumatic

Size 2” TC End

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 Design Qualification ( DQ ) Version: 1.0

Sr.No. DESCRIPTION SPECIFICATIONS

7.8 Coating Pan Assembly

Manufacturer ACG Pharma Tech. Pvt. Ltd.

MOC SS 316L

Punched perforations Hole dia 3mm

Outside dia. Ø1570 mm

Max. Volume 500 Litres

Surface finish (Inside) Mirror Finish ( Ra Max. 0.2µm)

Surface finish (Outside) Matt Finish ( Ra Max. 1.32µm)

7.8.1 Differential Pressure Transmitter Across Pan

Manufacturer Sensocon

Pressure Range - 100 to 100 mm WC

Accuracy 0.5%

7.8.2 Mixing baffles (Standard ) - 05 Nos

Manufacturer ACG Pharma Tech. Pvt. Ltd.

MOC SS 316L

Surface Finish Mirror Finish ( Ra Max. 0.2µm)

Type Fischer Type

7.8.3 Gear Box

Manufacturer Sew Eurodrive

Type KF77AM100/RS

Reduction Ratio 64.75

7.8.4 Pan Motor

Manufacturer CG Motors

Motor Type Flameproof

Motor Power 2.2 kW/3HP

Supply 415V ± 10 % Vac, 50Hz, 3 Phase

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Sr.No. DESCRIPTION SPECIFICATIONS

7.8.5 Pan Drive Bearing (Sieve bearing)

Manufacturer Rothe Erde

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Sr.No. DESCRIPTION SPECIFICATIONS

7.9 Top Railing assembly

Manufacturer ACG Pharma Tech. Pvt. Ltd.

MOC SS 304

7.9.1 Top enclosure assembly

Manufacture ACG Pharma Tech. Pvt. Ltd.

MOC SS 304

7.9.2 Front Arm Assembly

Manufacturer ACG Pharma Tech. Pvt. Ltd.

MOC SS 304

7.9.3 Front Door with ‘D’ type glass opening assembly

Manufacturer ACG Pharma Tech. Pvt. Ltd.

Glass MOC Toughen Glass

Position Front

Sealing Silicone Gasket

7.9.4 Film Coating Arm Assembly (Colapsible type)

Manufacturer ACG Pharma Tech. Pvt. Ltd.

MOC SS 316L

7.9.5 Spray Nozzles (X – One ), Qty - 5 Nos.

Manufacturer Schlick, Germany

MOC SS316L

Nozzle Size Ø 1.2 mm

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Sr.No. DESCRIPTION SPECIFICATIONS

7.9.6 WIP troll ball on spray arm for inside Pan

Manufacturer Siddharth

MOC SS 316

Capacity 70 lpm

Connection ¾” BSP size

7.9.7 Manifold Assembly for Spray Liquid

Manufacturer ACG Pharma Tech. Pvt. Ltd.

MOC SS 316L

Clamping TC end clamping

Outlet Ports 5 Nos

7.9.8 Spray Pump

Manufacturer Flowtech

Model FP-04

Pump Type Single Head

7.9.9 Spray Pump Motor

Power 0.75 kW / 1 HP

Supply 415V ± 10 % , 50Hz, 3 Phase

Type Flameproof

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Sr.No. DESCRIPTION SPECIFICATIONS

7.9.10 Discharge Assembly: (Unloading device )

Manufacturer ACG Pharma Tech. Pvt. Ltd.

Material SS 316L

Discharge Assembly ( Hood & Chute )

Surface Finish
Mirror Finish
( Inside & Outside )

Discharge Funnel

Surface Finish ( Inside ) Mirror Finish

Surface Finish ( Outside ) Matt Finish

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Sr.No. DESCRIPTION SPECIFICATIONS

7.10 Exhaust System

7.10.1 Exhaust Shoe assembly

Manufacturer ACG Pharma Tech. Pvt. Ltd.

MOC SS 316L

Sealing Silicone Gasket

7.10.2 Exhaust Air Flap

Manufacturer ACG Pharma Tech. Pvt. Ltd.

Housing – MOC Aluminium

Flap Disc – MOC SS 304

Drive Shaft – MOC SS 304

Sealing – MOC Silicone

Drive Pneumatic Actuator, Rotex make

Model ECF100

Limit Switch DXLW1A2-4R

7.10.3 Exhaust Temperature Sensor

Manufacturer RADIX

Type RTD PT 100

Sensor MOC SS 316L

Temperature Range 0-150 oC

Accuracy + 0.15 at 0 oC and 0.35 at 100 oC

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Sr.No. DESCRIPTION SPECIFICATIONS

7.10.4 Wet Scrubber ( FRP Lining) Explosion Proof

Manufacturer Polluteck (Pilani Envirotech)

Type Venturi Scrubber

Capacity 6000 CMH

Inlet gas temperature 40 – 50 deg C

Inlet Dust (assumed) 300-500mg/nm³

Water Recirculation 10m³/hr

Pressure drop 250mmwc

Shell : MS with epoxy painting,

Material of construction Spray Nozzle : SS304,
Mist eliminator : PP

Pump

Type Kirloskar Brothers Limited

MOC CI + MS

Voltage 415V

Total Head 20 mtr

Capacity 1.4 lps

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Sr.No. DESCRIPTION SPECIFICATIONS

7.10.5 Exhaust Blower assembly

Manufacturer Jitamitra Electro Engg. Pvt. Ltd

Impeller Material SS 304

Housing Material MS

Air Flow Capacity 6000 CMH

Static Diff. Pressure 1300 mmWG

Blower Motor ( Energy Efficient Motor )

Manufacturer CG Motors

Type Flame Proof

Motor Power 30 kW / 40 HP

Power Supply 415+/-10% , 50 Hz

Silencer for Blower Yes

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Sr.No. DESCRIPTION SPECIFICATIONS

7.11 Booster Pump Assembly

Manufacturer ACG Pharma Tech. Pvt. Ltd.

Fittings and interconnections

SS 316
MOC

PUMP

Make Grundfos

Model CM 10-3 ARGV AQQV FAAN

Material SS 316

BALL VALVE WITH ACTUATOR AT INLET AND OUTLET

Make Micro pneumatics.

Type Pneumatically operated ball valve

Material SS 316

1½” – 02 Nos – For Inlet

Size
1”NB – 1 No.- Outlet

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S.No. DESCRIPTION SPECIFICATIONS

7.12 Solution Holding Tank : 01No.

Manufacturer ACG Pharma Tech. Pvt. Ltd.

Capacity 200 Ltrs

Material SS 316L

Inside Finish Mirror Finish

Outside Finish Matt Finish

Driven By (Air Motor )

Make San Air Tools

Type Pneumatic

Product Temperature Gauge

Make Radix

Range 0-200 Deg. C

Stirrer Assembly

ACG Pharma Technologies

Manufacturer
Pvt.Ltd.

Material SS 316L

Wheel PU wheel 2 fix type, 2 with brake

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 Design Qualification ( DQ ) Version: 1.0

Sr.No. DESCRIPTION SPECIFICATIONS

7.13 PLC

CPU Make Mitsubishi

Model FX3U-64M

PLC Input / Output 32 Input / 32 Output

485 BD, Ethernet card &

Communication Card
FX2N232IF,

7.13.1 Analog Input Card ( Analog to Digital ), Qty : 2 Nos

Make Mitsubishi

Model FX2N-8AD

Channels 8 Channels

7.13.2 Analog Output Card (Digital to Analog) – 1 No.

Make Mitsubishi

Model FX3U- 4DA– ADP

Channels 4 Channel

7.13.3 Temperature Transmitter, Qty - 3 Nos.

Make Radix Electro systems

Model TX1DR

Inlet, Exhaust & Dehumidification

Applied for
Temperature

Temperature Range 0-150 oC

Location Control Panel

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Sr.No. DESCRIPTION SPECIFICATIONS

7.13.4 Pressure Transmitter, Qty - 3 Nos.

Manufacturer Gefran

Operating air pressure,

Applied For
Atomisation Air, Pattern Air

Range 0-10 bar

Output 4-20 mA

Accuracy < + 0.02% FSO

7.13.5 I to P Converter , Qty : 2 Nos.

Make SMC

Model ITV1030

Dehumidification & Heater

Applied For
Control Steam Valve

Location Control Panel

Output 0.05 to 5 kg/cm2

7.13.6 I to P Converter , Qty : 2 Nos.

Make SMC

Model ITV1050

Applied for Atomisation & Pattern Air

Output 0.05 to 9 kg/cm2

7.13.7 Air Control System

Make Pall

MOC SS304

Filtration 0.2 µm

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 Design Qualification ( DQ ) Version: 1.0

Sr.No. DESCRIPTION SPECIFICATIONS

7.14 PC Control

Box type IPC

Manufacturer Contec

Model BXS959

Monitor

Contec (Maestrotrk Innovations

Manufacturer
Pvt. Ltd.)

Display Size 15”

7.15 Printer

Make HP

Model M 252n

7.16 ACVF Drive

Make Mitsubishi

1. ACVF Drive-for Pan Gear Motor

Rating 2.2 kW / 3 HP

2. ACVF Drive-for Inlet Blower Motor

Rating 11 kW / 15 HP

3. ACVF Drive-for Exhaust Blower Motor

Rating 37.0 kW / 50 HP

4. ACVF Drive-for Spray Pump Motor

Rating 0.75 kW / 1 HP

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 Design Qualification ( DQ ) Version: 1.0

8 Details Of Utilities:-

DESCRIPTION SPECIFICATIONS

8.1 Electrical

Phase 3 Phase & Neutral

Voltage / Frequency 415V AC + 10 % / 50 Hz

Total Electric consumption 53.93 kVA

Cable schedule

Exhaust Blower 10sqmm X 3 Core + Earth, Copper

Inlet Blower 2.5sqmm X 4 Core Copper

Scrubber Pump 2.5sqmm X 4 Core Copper

Pan Motor 2.5sqmm X 4 Core Copper

Spray Pump 2.5sqmm X 4 Core Copper

WIP Booster Pump 2.5sqmm X 4 Core Copper

Mains Cable 16mm2 X 3.5 Core + Earth, Copper

8.2 Compressed Air

Consumption 145 m3/h at 6 bar

Flow pressure Min. 6 bar (Kg)

Quality oil, water & dust free

8.3 Steam consumption

Steam Pressure Min 3.5 bar (g)

Steam Consumption 362 Kg/hr.

8.4 Chilled water consumption

Chilled water Consumption 161 GPM

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 Design Qualification ( DQ ) Version: 1.0

9 Identification Of Component For Calibration

In the SMART COATER, following are the components, which need calibration.

Sr.No. DESCRIPTION LOCATION

Temperature Sensors

1. Dehumidification Temp. AHU

2. Inlet Temp. Lower Pnenum/Inlet Duct

3. Exhaust Temp. Exhaust Duct

Temperature Transmitters

4. Dehumidification Temp. Control Panel

5. Inlet Temp. Control Panel

6. ExhaustTemp. Control Panel

Pressure Transmitters

7. Operating Air Control Panel

8. Atomising Air Machine

9. Pattern Air Machine

I to P Converters

10. Relative Humidity Control Panel

11. Heater Control – Steam Control Panel

Valve

12. Atomising Air Control Panel

13. Pattern Air Control Panel

D.P. Transmitters

14. Pan D.P. Machine

15. Fine (EU7) Filter D. P. AHU

16. HEPA Filter D. P. AHU

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10 Material Of Construction

DESCRIPTION SPECIFICATIONS

A. Product Contact Parts

Coating Pan SS.316L

Mixing baffles SS.316L

Manifolds for spray nozzle SS.316L

B. Product Non-Contact Parts

Inlet air handling unit ( Inside) SS.304

Machine Housing SS.316L/ SS304

Back, front & side covers SS.304

Front Door ‘D‘ Type Toughened glass

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 Design Qualification ( DQ ) Version: 1.0

11 P&I Diagram For Reference & Approval

Attached as annexure DQ/ANX/I

Approval status: APPROVED/ NOT APPROVED

Any change in the approved diagram: Yes/ No.

If yes, the reason for change

………………………………………………………………………………………………………

………………………………………………………………………………………………………

………………………………………………………………………………………………………

………………………………………………………………………………………………………

………………………………………………….........................................................................

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12 Equipment Orientation With Room Lay Out:

Attached as annexure DQ/ANX/II

Approval status: APPROVED/ NOT APPROVED

Any change in the approved orientation layout: Yes/ No.

If yes, the reason for change

………………………………………………………………………………………………………

………………………………………………………………………………………………………

………………………………………………………………………………………………………

………………………………………………………………………………………………………

………………………………………………….........................................................................

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13 Safety Features And Alarms:

13.1 Sealing System

The sealing system of this pressure shock resistant machine consists of the following

inflatable gaskets:

- Both side of machine with side doors.

- Front door of machine

All these doors are air tight with the help of locking screws & the gasket inside.

13.2 Alarm / Fault Administration

Following is the list of alarms that are incorporated for the safety of the Equipment and

the operators:

On the display screen the key “Alarm” will flash red. The process will be switched OFF

automatically if the alarm is critical. The Operator has to acknowledge the alarm by

pressing ACKNOWLEDGE KEY in alarm history screen.

The operator then has to attend to the specific problem. After taking the appropriate

action, the “ACKNOWLEDGE KEY” button has to be pressed that will make the flashing

of “Alarm” from the screen disappear with the flashing Red LED will turn GREEN. The

process will not start until the operator presses the “Process ON” button. At the time of

shutdown, the process time counters stops and is restarted only when the operator

presses the “Process ON” button. This ensures that the actual time taken by the process

is recorded and the shutdown time is ignored. The facility of alarm printing is also

provided to have a record of details of the alarm occurred (description, date & time).

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14 List Of Alarms:

Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
1 INLET BLOWER If Inlet Motor Protection
MPCB TRIPPED Circuit Breaker trip
because of Overload or
Short Circuit or it is kept x x x x x x x
off, then this alarm will be
generated.
2 INLET BLOWER If the Inlet Drive goes in
DRIVE ERROR error mode then this alarm x x x x x x x
is generated.

3 PAN MOTOR If Pan Motor Protection

MPCB TRIPPED Circuit Breaker trip
because of Overload or
Short Circuit or it is kept x x x x x x x
off, then this alarm will be
generated.

4 PAN MOTOR If the Pan Drive goes in

DRIVE ERROR error mode then this alarm x x x x x x x
is generated.

5 PAN IS NOT During Pan running if Pan

MOVING is not moving due to any
reason, then this alarm will x x x x x x
be generated.

6 SPRAY PUMP If Spray Pump Protection

MPCB TRIPPED Circuit Breaker trip
because of Overload or
Short Circuit or it is kept x x x x x x x
off, then this alarm will be
generated.

7 SPRAY PUMP If the Spray Pump Drive

DRIVE ERROR goes in error mode then x x x x x x x
these alarms is generated.

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Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
8 CHECK Due to malfunction in
ELECTRICAL Electrical Supply, i.e.,
SUPPLY MONITOR Over voltage, Under
x x x x x x x
voltage, Single phase etc,
this alarm will be
generated.
9 COATER RHS If the RHS door is open
DOOR OPEN then this alarm is x x x x x x x
generated.
10 COATER LHS If the LHS door is open
DOOR OPEN then this alarm is x x x x x x x
generated.
11 SPRAY GUN ARM If the machine Spray Gun
OUT Arm is out then this alarm x x x x x x
is generated.
12 MAINS POWER If Main Incoming Power
FAILURE Supply is stopped / Fails
then this Alarm will be
generated.This alarm will x x x x x x x
also be generated if
Emergency Stop on coater
machine is pressed.
13 CHECK If the Emergency stop on
EMERGENCY Coater M/C is pressed
STOP COATER then this alarm will be x x x x x x x
MACHINE generated along with
Mains Power Failure.
14 EMERGENCY If Emergency Stop On
STOP PRESSED HMI Panel Pressed, then
x x x x x x x
this alarm will be
generated.
15 AHU DOOR OPEN If any of the AHU door
found open, then this x x x x x x x
alarm will be generated.

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Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
16 EXHAUST If Exhaust Motor
BLOWER MPCB Protection Circuit Breaker
TRIPPED trip because of Overload
or Short Circuit or it is kept x x x x x x x
off, then this alarm will be
generated.
17 EXHAUST DRIVE If the Exhaust Drive goes
ERROR in error mode then this x x x x x x x
alarm is generated.
18 M/C DRAIN WATER If Water level in Drain
LEVEL HIGH Line found high then this
alarm will be generated x x x x x x x
and process will stop. No
detection during WIP on.
19 M/C DRAIN VALVE If the drain valve ON
NOT OPENED command is ON and valve
x x x x x
doesn’t open then this
alarm is generated.
20 M/C DRAIN VALVE If the drain valve ON
OPEN command is OFF and
x x x x x
valve found open then this
alarm is generated.
21 INLET FLAP NOT During the machine
OPERATED operation, if the Inlet Flap
x x x x x x
not operated, then this
alarm will be generated.
22 EXHAUST FLAP During the machine
NOT OPERATED operation, if the Exhaust
Flap not operated, then x x x x x x
this alarm will be
generated.

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Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
23 OPERATING AIR If the Air Pressure drops
PRESSURE < below the minimum set
x x x x x x x
MINIMUM value, then this alarm will
be generated.
24 PATTERN AIR If the Pattern Air Pressure
PRESSURE < drops below the minimum
x x
MINIMUM set value, then this alarm
will be generated.
25 INLET During the machine
TEMPERATURE < operation, if the Inlet air
MINIMUM temperature drops below
the minimum set value,
then this alarm will be
generated. Detection if x
Inlet Temp is reached and
then dropped or the temp
is less than minimum and
operator tried to start the
machine.
26 INLET During the machine
TEMPERATURE < operation, if the Inlet air
MINIMUM temperature drops below
MINIMUM the minimum minimum set
value, then this alarm will
be generated. Detection if x x
Inlet Temp is reached and
then dropped or the temp
is less than minimum and
operator tried to start the
machine.

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Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
27 EXHAUST During the machine
TEMPERATURE < operation, if the Exhaust
MINIMUM air temperature drops
below the minimum set
value, then this alarm will
be generated. Detection if x
Exhaust Temp is reached
and then dropped or the
temp is less than minimum
and operator tried to start
the machine.
28 EXHAUST During the machine
TEMPERATURE < operation, if the Exhaust
MINIMUM air temperature drops
MINIMUM below the minimum
minimum set value, then
this alarm will be
x x
generated. Detection if
Exhaust Temp is reached
and then dropped or the
temp is less than minimum
and operator tried to start
the machine.
29 INLET During the machine
TEMPERATURE > operation, if the Inlet air
MAXIMUM temperature crosses the
x
maximum set value, then
this alarm will be
generated.
30 INLET During the machine
TEMPERATURE > operation, if the Inlet air
MAXIMUM temperature crosses the
x x
MAXIMUM maximum maximum set
value, then this alarm will
be generated.

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Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
31 EXHAUST During the m/c operation,
TEMPERATURE > if Exhaust Air temperature
MAXIMUM crosses the maximum set x
value, then this alarm will
be generated.
32 EXHAUST During the m/c operation,
TEMPERATURE > if Exhaust Air temperature
MAXIMUM crosses the maximum
x x
MAXIMUM maximum set value, then
this alarm will be
generated.
33 INLET If inlet temperature value
TEMPERATURE found less than 1 or
SENSOR FAIL greater than 152 deg cel, x x x x x
then this alarm will be
generated.
34 EXHAUST If exhaust temperature
TEMPERATURE value found less than 1 or
SENSOR FAIL greater than 152 deg cel, x x x x x
then this alarm will be
generated.
35 INLET AIR FLOW < During The Process
MINIMUM operation if the Inlet
airflow drops below the
minimum set point then
this alarm is generated. x
Detection if Air Flow
reached set point and
dropped to min level.

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 Design Qualification ( DQ ) Version: 1.0

Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
36 INLET AIR FLOW < During The Process
MINIMUM operation if the Inlet
MINIMUM airflow drops below the
minimum minimum set
x x x
point then this alarm is
generated. Detection if Air
Flow reached set point
and dropped to min level.
37 INLET AIR FLOW During process short
SENSOR FAIL circuit or open circuit of
x x x x x x
sensor will generate this
alarm.
38 DP PAN < During the m/c operation,
MINIMUM if the Differential Pressure
across PAN drops below
x
the minimum set value,
then this alarm will be
generated.
39 DP PAN > During the m/c operation,
MAXIMUM if the Differential Pressure
across PAN goes above
x
the maximum set value,
then this alarm will be
generated.
40 DP PAN > During the m/c operation,
MAXIMUM if the Differential Pressure
MAXIMUM across PAN goes above
x x x x x x
the maximum maximum
set value, then this alarm
will be generated.
41 DP PAN SENSOR Open circuit and short
FAIL circuit of sensor will x x x x x x
generate this alarm.

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 Design Qualification ( DQ ) Version: 1.0

Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
42 DP HEPA INLET > During the machine
MAXIMUM operation, if Differential
Pressure across Inlet
HEPA filter crosses the x
maximum set value, then
this alarm will be
generated.
43 DP HEPA INLET > During the machine
MAXIMUM operation, if Differential
MAXIMUM Pressure across Inlet
HEPA filter crosses the x x x x x x
maximum maximum set
value, then this alarm will
be generated.
44 DP HEPA INLET > During the machine
MINIMUM operation, if Differential
Pressure across Inlet
HEPA filter drops below x
the minimum set value,
then this alarm will be
generated.
45 DP EU7 INLET > During the machine
MAXIMUM operation, if Differential
Pressure across Inlet EU7
x
filter crosses the maximum
set value, then this alarm
will be generated.
46 DP EU7 INLET > During the machine
MAXIMUM operation, if Differential
MAXIMUM Pressure across Inlet EU7
filter crosses the maximum x x x x x x
maximum set value, then
this alarm will be
generated.

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 Design Qualification ( DQ ) Version: 1.0

Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
47 DP EU7 INLET > During the machine
MINIMUM operation, if Differential
Pressure across Inlet EU7
filter drops below the x
minimum set value, then
this alarm will be
generated.
48 ATOMISATION AIR During the machine
PRESSURE LOW operation or Spray Test if
ATM Pressure drops less
than 0.5 of min value , x x x
then this alarm will be
generated and trip the
Spraying Process.
49 SCRUBBER PUMP If Scrubber Pump Motor
MPCB TRIPPED Protection Circuit Breaker
trip because of overload or
x x x x x
short circuit or it is kept off,
then this alarm will be
generated.
50 SCRUBBER During Process Off, if
WATER LEVEL water level in Scrubber
LOW tank is less than desired x
level, then this alarm will
be generated.
51 SCRUBBER During Process ON, if
WATER Scrubber water pressure
PRESSURE LOW drops below the preset x
value, then this alarm will
be generated.
52 WIP BOOSTER If WIP Booster Pump
PUMP MPCB MPCB Trips due to over
TRIPPED current or Short circuit or it x x
is kept off then this alarm
will be generated .

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 Design Qualification ( DQ ) Version: 1.0

Exhaust / Inlet Blower Stop

M/C Washing Stop

Spray Pump Stop
Sr. Description of

Spray Test Stop

Pan Motor Stop

Interlock / Reason
No. Alarm

Heater Stop
View
53 PROCESS TIME During Manual mode, if
END the phase time completed,
then this alarm will be
generated. During Auto
mode if all the phases are x x x x x
completed then this alarm
is generated. Process will
trip.

If any one of the alarm occurs there will be RED flashing indicator on IPC along with the
buzzer mounted inside the control panel. This Audio- Visual indication will guide the
operator about the tripping of machine, operator then have to click the button “Alarm” on
the IPC which will show the actual reason for the machine tripping.

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 Design Qualification ( DQ ) Version: 1.0

15 FAT Procedure:

Factory Acceptance Test Procedure shall be as follows:

After the completion of erection work of the machine, client shall be informed to perform

the factory acceptance test (FAT).

Client 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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 Design Qualification ( DQ ) Version: 1.0

16 Appendix

16.1 List Of Abbreviations

cGMP Current Good Manufacturing Practices

cGEP Current Good Engineering practices

AISI American Iron & Steel Institute

WIP Wash In Place

MS Mild steel

FLP Flame Proof

SS Stainless Steel

CFM Cubic Feet Per Minute

kW Kilo Watt

DQ Design Qualification

HEPA High Efficiency Particulate Air Filter

HMI/MMI Human/Man Machine Interface

FAT Factory acceptance test

DP Differential Pressure

PLC Programmable Logic Controller

Controller- Algorithm for control loops with

PID
Proportional (P), Integral (I), and Differential (D) factor.

IQ Installation Qualification

OQ Operational Qualification

PIC/S Pharmaceutical Inspection Convention Scheme

SCADA Supervisory Control and Data Acquisition

PQ Performance Qualification

URS User Requirement Specification

MOC Material of construction

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 Design Qualification ( DQ ) Version: 1.0

16.2 Reference Documents

( To be supplied with Installation Qualification documents )

Manufactures Brochure (s) / Manual (s). (Title and Location).

To be supplied with the Installation qualification documents

1. Instruction & Maintenance manual

2. Calibration certificates

3. Material of construction certificates

4. Instruction manual for PLC

5. Test certificates of motors

ANNEXURE LIST

( To be supplied with Installation Qualification documents )

S.NO. DESCRIPTION ANNEXURE NO.

1. P & I Diagram DQ/ANX/I

Approved Equipment Room

2. DQ/ANX/II
Lay out:

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