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DQ of Blister Packing Machine (BQS)

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DQ of Blister Packing Machine (BQS)

BY PHARMACEUTICAL GUIDANACE ON JUNE 28, 2016

OTHER, QUALIFICATION, VALIDATION & QUALIFICATION

TABLE OF CONTENT
Objective
Scope
Responsibility
Machine description
Technical specification
Technical specifications and make of sub-components/ bought out items.
Details of Utilities

FACEBOOK

Identification of components for calibration

Material of construction of all components

Safety features and alarms

FAT procedure
Change control procedure
Qualification Document report approval
Appendix

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OBJECTIVE
To design, engineer, and supply the Blister Packing Machine (Model: BQS) as per the URS and to ensure
that 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 in the machine.
SCOPE
The scope of this qualification document is limited to the Design Qualification of Blister Packing Machine
(Model BQS) for the Pam Pac Machines Pvt. Ltd. This qualification document is part of a validation
activity for the Blister Packing Machine (Model BQS).
Qualification of support utilities is not within the scope of this qualification document.
The equipment shall be used for the blister format drawings and the change parts there of as supplied
by the above supplier. The equipment shall operate under dust free environment and conditions as per
the GMP requirements.
RESPONSIBILITIES
CLIENT
To check and approve the design qualification.
MANUFACTURER
To design, engineer and provide the complete technical details of the equipment
pertaining to its design qualification viz.
Machine overview
General arrangement drawing.

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 Specifications of the sub-components/ bought out items, and their make, model
& quantity, and backup records/ brochures.
Details of Utilities,
Identification of components for calibration
Material of construction of all components
Brief process description
Safety features and alarms
To facilitate the client for the Factory acceptance test of the machine at their works/
site.
To confirm the safe delivery of the equipment to the user site.
To ensure that no un-authorized and / or unrecorded design modifications shall take
place. If at any point in time, any change is desired in the mutually agreed design,
Change control procedure shall be followed and documented.
To ensure the proper installation and commissioning of the equipment.
MACHINE DESCRIPTION
Pam-Pacs Blister Packing Machine consist of following major stations
Forming foil unwinding station
This station is provided for various types of forming foils like PVC, PVDC, and Alu-Alu etc. Foil is clamped
by the leading screw. The center distance with respect to base plate face is 170 mm, which can be
maintained with the help of adjusting screw. The tension on the foil can be adjusted by the spring
provided from backside. Foil unwinding operation is carried out with help of separate drive motor. To
have a constant pressure on the foil operating of drive is controlled by the sensors.
Forming foil sensor
A lever type of sensor is fitted on the foil guide roller which will show the presence / non-presence of foil.
In case of foil is fully consumed or foil is broken then there will be an indication on the MMI as FOIL END
and machine will stop in Run mode
Base foil splicing station
Two clamps are fitted on the splicing plate which hold the base foil for which splicing is to be done. Foils
are to be cut by paper knife and join with help of adhesive tape. The joint detection sensor is provided
which sense the joint and reject the blister automatically with the help of program in the PLC. The joint
should be always on the top side.
Heating station
Heating station is required to heat the forming foil in case of PVC-Alu blister formats. Two heating plates
are provided i.e. bottom and top side. For both the plates temp. is kept @ 110 125 degree C. depending
upon the size of the foil and cavity size .
To avoid the sticking of forming foil with heating plates, teflon coating is provided on heating plates. Top
heating plate is operated with the help of pneumatic cylinder. Bottom heating plate and top heating plate
are with embedded type heater.
Dedicated feeding station (Optional)
This station consist of hopper ,linear vibrator and rotary vibrator. Product material is put into the hopper
which is of 50 Lt. capacity. From hopper the product transferred into the linear vibrator, which vibrates
with the help of electro magnetic coils. The vibrations are controlled by the sensor provided in the rotary
vibrator. The vibration level can be changed with the help of vibrator controller. From linear vibrator the
product is transferred into the rotary vibrator. The vibration level in rotary vibrator is controlled by
controller. In case of PVC-Alu. formats from rotary vibrator the product is fed into the formed cavities with
the help of either continues filling shoe or through feeder springs. In case of Alu-Alu format, product is fed
into the feeding drum cavities and further the product is dropped into the formed cavities from drum.
Forming station
PVC Alu forming
This station consists of bottom plate, top plate, bottom forming plate, blowing plate and other pneumatic
parts. The heated foil is clamped by the hydraulic pressure (90-100 Bar) with Power Pack and the air is
blown from blowing plate ( 6 Bar ).Operation of clamping the plates and blowing the air is done through
electronic timings.
Alu Alu forming ( Optional )
This station consists of bottom plate, top plate, bottom-forming plate, plugs mounting plate. Heating of
base foil is not required. The forming of the blister cavities is done with the help of plugs mounted on
upper plate These plugs are operated by the pneumatic cylinder (Pressure 6 Bar).

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 Overprinting station (Optional)

This station is used to give batch code printing provision on the blister. The ink used is DIPL 33 and
thinner is DIPL 20 for the ink cartridge. The stereos are fixed on the stereo roller and foil is passed
through the stereo roller and pressure roller to get the impressions of stereos on the foil.
Print registration system (Optional)
Basically this system is provided to maintain position of the particular print matter on the Al.foil to the
forming pocket. The eye mark on the Al.foil is sensed by the print mark scanner in every cycle and the
correction is done by pulling roller so that the matter on the lidding foil matches with particular pocket or
with particular blister.
Non filled detection system (NFD) (Optional)
Basically this system is provided to detect any non-filled blisters. Each and every pocket of the blister is
sensed by the sensor. After getting the signal, the empty blisters are rejected by the suckers provided in
the pick up station which are connected to the pneumatic line and the vacuum line.
Sealing station
This station consist of bottom plate, top plate, bottom sealing plate, top sealing plate, heater plate and
pneumatic parts. To match sealing station with formed blister, sealing station can be adjusted with the
help of allen key. After station gets closed, the hydraulic pressure operates and sealing takes place. The
temp. of the top sealing plate is kept from 180- 200 degree C. depending upon the format size. The
hydraulic pressure is same like forming station as operated by same Power Pack.
Cooling station
Cooling station is used to cool the sealed web immediately after sealing. This station consist of top plate,
bottom plate and the change part cooling plate. The web is guided in between top plate and the change
part cooling plate. The bottom plate is operated in every cycle and the operation is controlled by the
pneumatic cylinder, which is operated by PLC.
Pulling station
The pulling station is used to pull the sealed web in continues motion. The web is pulled by pulling roller
and the thrust roller. In this the speed of the pulling roller is synchronized with main cam.
Embossing cum perforation station ( Optional )
This station is provided to do the embossing ( for providing batch no. etc.) and making perforation on the
blister as per the requirements. The perforation cum embossing is a change part which consist of sliding
plate, moving plate and fixed plate. In case of only embossing, embossing unit is a basic part of the
machine and the spacers with embossing tools with holder is a change part. This station is operated by
eccentric. The speed synchronization is done with help of Servo motor.
Indexing station
This station pushes the sealed web into the punching station with the help of indexing roller which is a
part of change part. The stroke (equal to blister width) is set with help of indexing change gears.
Punching station
Punching unit is operated with the help of eccentric and levers. This unit consist of punch , cutting plate
and support plate which is a change part as per the size of the blister. The speed synchronization is done
with help of Servo motor.
Pick up station
This system is provided to pick up the blisters after cutting operation. This system is operated with
pneumatic pressure and vacuum. Good blisters (filled) are accepted and picked up by the suction cups
provided and dropped in 90 degree. The half filled blisters are picked up and dropped at 45 degree into
the rejected bin.
Control panel / switch board
MMI panel and control box is provided on the machine to carry out the following functions.
Control of forming and sealing temp.
Control of vibrator and feeder motor speed
Control of main motor speed.
To regulate the power supply
Contactors and drives are fitted in control panel.
Brief Process Description
General Function

Blister packing machine BQS is a flat bed compressed air forming and flat sealing continuous motion
machine suitable for blister packing of tablets/hard gelatine capsules / soft gelatine capsules and cavity
depth upto 12mm.
BQS can handle PVC/PVDC & ALU. -ALU. as base films for forming the cavities. Aluminum foil or Paper
foil is used for sealing the cavities & suitable lacquer is used to seal the film to base foil.
Working
In case of thermoplastic PVC/PVDC thermoplastic as base foil, cavities are formed by compressed air
normally 4-6 bar after heating the foil in heating station at 120 C. This web is formed in continuous
motion through forming & sealing station & pulled by pulling roller. Forming & sealing stations carry out
the shuttle movement. Formed web is then sealed in sealing station with suitable foil.
After sealing, sealed web is passed through perforation /embossing station & then to punching station for
cutting the blister. Different types of product infeed systems are used for feeding the product in cavities
at higher speed in continuous motion.
The machine is designed for single or twin lane operation .Its output depends on type of product, its
layout & arrangement of stripes in one stroke as well as infeed of the products into the cavities.
All systems are selected to produce the maximum output of the quality blister stripes. The machine is
also designed to handle special type of films like Alu-Alu with additional parts.
Following are the forming techniques used in BQS Compressed air forming:
Flat bed machines are normally designed with compressed air forming.
Thermoplastic film is heated by flat heating plates at 120 130 C & then passed in forming station to
form the cavities .In forming station compressed air with 4-6 bar is blown on hot film which is clamped
between forming & blowing plates.
Cavities formed by this process are stiff at bottom side compare to vacuum forming & also very less
temperature is required to form the cavities as cavity formation process is very fast.
Plug assisted air forming:
In plug assist air compressed forming, first partial forming takes place by inserting the plug into the cavity
with the heated PVC web and then the compressed air is injected from the sides of the plug for cavity
forming. In plug assist forming cavity formed is of more uniform thickness and thickness achieved is
more compared to vacuum forming and compressed air forming. Mainly it is recommended for deep
cavities.
Cold forming (ALU. -ALU. Blister forming):
In recent years a new base film is developed having extremely good barrier properties for hydroscopic
products or products affected by light. In cold forming, forming takes place with help of plugs (Metallic
or Teflon) which are pressed with very high pressure against firmly clamped ALU-ALU film (special type
Multi layered film). Blister produced with this type of forming gives very good barrier properties & product
stability. Packing cost is comparatively high.
Forming temperature Air Compressed forming & Plug Assisted forming
Type of Forming

Forming Temp Range

Pressure

Compressed air forming

110 130

4 -6 Bar Pressure

Plug assist air Forming

85 110

4- 6 Bar Pressure

TECHNICAL SPECIFICATIONS
Description

Specification

1. Model

BQS

2. Type

Thermoforming Blister Packing Machine

3. Weight
Basic machine

2500 kg approx.

Packing case

3400 kg approx.

4. Dimension

4500L X 1900W X 2000H

5. Output

45 Cycles/min. for PVC/ALU forming

35 Cycles/min. for ALU/ALU forming
200 cycles / min. in punching station.

6. Forming area

240 x 180 mm
Max. Draw depth 12 mm

Max. Draw of Length 180 mm.

7. Max. Roll Diameter

450 mm x 252 mm width

(Forming Film)

74 76 mm core dia.

8. Max. Roll Diameter

250 mm x 246 mm width

(Lidding Foil)

74 76 mm core dia.

9. Suitable Working

5 to 40 Degree C.

Temperature range
10. Noise Level

70 db (approx.)

11. Suitable Humidity range

40 70 %

for the machine

12. Electrical Supply

Supply Voltage: 415 V AC +/- 10% Phase + Earth

Requirement

Supply Frequency: 50 Hz +/- 2%

Power Consumption: Average: 7 KW
Peak: 14 KW.

13. Compressed Air

30-35 CFM at 7-8 bar near the machine.

Requirement
14. Water requirement

Chilled water at 18-20 + / 2 degree C

(Flow 16 Liters/min)
Cooling Capacity 4500 Kcal/hr.

TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB- COMPONENTS USED / BOUGHT OUTS.

6.1 Sub assembly Name = PVC Unwinding station
Manufacturer = Pam Pac Machines
Item Name

Description

Specification

PVC

Make

Technocraft

Unwinding motor

HP

0.15 HP

RPM

1400 RPM

Voltage

415 V AC

Phase

Three Ph.

Quantity

1 No.

Material

Silicon Rubber

Size

50 X 5

Quantity

2 Nos.

Make

Datalogic

Model

TL 10

Specification

PNP / 24 V DC

Quantity

1 No.

Type

Inductive

Specification

M10

Quantity

2 No.

Rubber ring

Base foil Joint

Detection Sensor

Sensor for Dancing

lever

6.2 Sub assembly Name = Heating station

Item Name

Description

Specification

Heating Plate (Bottom)

Material

Al. Casting (LM 9)

Treatment

Teflon coating

Quantity

1No.

Heating plate top

Material

Al. Casting (LM 9)

Watt

Quantity

1No.

Pneumatic Cylinder

Make

Festo

(Tendom)

Size

25 x 30

Quantity

1 No.

Make

Festo

Size

50 x 25

Quantity

1 No.

Pneumatic Cylinder

6.3 Sub assembly Name = Forming station

Manufacturer = Pam Pac Machines
Item Name

Description

Specification

Top Plate

Material

LM 6 ( Alloy )

Treatment

Anodizing

Quantity

1 No.

Material

IS 734 Al. Alloy

Treatment

Anodizing

Quantity

1 No.

Make

Zeon Make

Working pressure

160 Bar

Motor make

Bharat Bijali

Motor HP

5 HP

Phase

3 Ph.

Voltage

415 V AC

RPM

1440 RPM

Quantity

1 No.

Hydraulic

Make

CETOP

Valve

Voltage

24 V

Quantity

1 No.

Hydraulic

Part No.

GPP 726

Cylinder

Make

IPH

Size

Dia. 8015

Quantity

1 No.

Material

SS 316

Finish

Buffed RA 0.2

Capacity

50 Ltrs.

Quantity

1 No.

Linear

Material

SS 316

Vibrator

Finish

Buffed RA 0.2

Quantity

1 No.

Item Name

Description

Specification

Vibrator

Make

Sai Control

Bottom Plate

Power pack

Hopper

Controller

( Linear )

Voltage

230 V 3 A

Quantity

1 No.

Vibrator

Make

Sai Control

Controller

Voltage

230 V 3 A

Quantity

1 No.

Vibrator

Make

Jadhav Brothers

Coil

Voltage

230 V

Watt

180 W

Quantity

1 No.

Vibrator

Make

Feedtech

Coil

Voltage

230 V

Watt

180 W

Quantity

1 No.

Distributor

Material

SS 316

plate

Finish

Matt

Quantity

1 No.

Vibrator

Material

58 CRV 4

Strips

Hardness

40 45 HRC

Treatment

Blackodising

Quantity

04 No.

Make

Siemens

HP

0.25 HP

RPM

1380 RPM

Voltage

415 V AC

Phase

3 Ph.

Quantity

1 No.

Gear for

Material

Hylum

unwinding

Quantity

1 No.

( Rotary )

( Linear )

( Rotary )

Aiuminium Roll
unwinding Motor

6.4 Sub assembly Name = Sealing station

Manufacturer = Pam Pac Machines
Item Name

Description

Specification

Top Plate

Material

Al-H 20 T 6

Treatment

Anodizing

Quantity

1 No.

Material

Al-H 20 T 6

Treatment

Anodizing

Quantity

1 No.

Make

Zeon

Working pressure

160 Bar

Motor make

Bharat Bijali

Motor HP

5 HP

Phase

3 Ph.

Bottom plate

Power pack

Voltage

415 V AC

RPM

1440 RPM

Quantity

1 No.

Hydraulic

Make

CETOP

valve

Voltage

24 V

Quantity

1 No.

Material

LM-9

Hardness

120 BHN

Treatment

GBB

Quantity

1 No.

Hydraulic

Part No.

GPP726

Cylinder

Make

IPH

Size

Dia. 80 x 15

Quantity

1 No.

Heater plate

6.5 Sub assembly Name = Cooling station

Manufacturer = Pam Pac Machines
Item Name

Description

Specification

Bracket

Material

LM 16

Hardness

90-100 BHN

Treatment

GBB

Quantity

1 No.

Material

H9 T6

Treatment

GBB

Quantity

1.No.

Material

H9 T6

Treatment

GBB

Quantity

1 No.

Top Plate

Bottom plate

6.6

Sub assembly Name = Overprinting station (Optional)

Manufacturer = Pam Pac Machines

Item Name

Description

Specification

Ink Cartridge

Size

Dia.50 X 245 Lg.

Ink type

DIPL 39

Thinner type

DIPL 20

Quantity

1 No.

Pressure

Material

M. S.

roller

Treatment

BNP

Quantity

1 No.

6.7 Sub assembly Name = Web Pulling station

Manufacturer = Pam Pac Machines
Item Name

Description

Specification

Pulling disc

Material

HC HCr

Front

Hardness

45 50 HRC

Treatment

Blackodizing

Pulling disc
rear

Gear Box

Servo motor

Bearings

6.8

Quantity

1 No.

Material

HC HCr

Hardness

45 50 HRC

Treatment

Blackodizing

Quantity

1 No.

Make

Bonfiglioli

Ratio

1:30

Quantity

1 No.

Make

B&R Automation

Torque

5.3 Nm

Quantity

1 No.

Make

SKF

Specification

6006 ZZ

Quantity

2 No.

Sub assembly Name = Punching and perforation station

Manufacturer = Pam Pac Machines

Item Name

Description

Specification

Gear Box

Make

Technocraft

Ratio

7.5:1

Quantity

1 No.

Make

B&R Automation

Torque

7.5 Nm

Quantity

1 No.

Cutting plate

Part No.

N.A. (Change part)

(change part)

Material

HCHCr

Hardness

58-60 HRC

Treatment

Blackodising

Quantity

1 No.

Punch

Part No.

N.A. (Change part )

(change part)

Material

HCHCr

Hardness

58-60 HRC

Treatment

Blackodising

Quantity

1 No. (Depends)

Change gear

Part No.

N.A. (Change part )

(Change part)

Material

EN8 / SAE 8620

Hardness

55-60 HRC

Treatment

Blackodising

Quantity

1 No.

Servo motor

6.9

Sub assembly Name = Punching and perforation station

Manufacturer = Pam Pac Machines

Item Name

Description

Specification

Moving plate

Material

EN-8

(Change part)

Treatment

Blackodising

Quantity

1 No.

Sliding plate

Part No.

N.A.(Change part )

(Change part)

Material

M.S.

Treatment

Blackodising

Quantity

1 No.

Support plate

Part No.

N.A.(Change part )

(Change part)

Material

H9 T6

Treatment

Anodized

Quantity

2 No.

6.10 Sub assembly Name = Pick up station

Manufacturer = Pam Pac Machines
Item Name

Description

Specification

Vacuum pump

Make

Indovac

Capacity

500 LPM

Pressure

25 of Hg.

Quantity

1 No.

Make

Hindustan

Supply voltage

415 V AC

HP

2 HP

RPM

1410 RPM

Phase

3 Ph.

Quantity

1 No.

Make

IWKA

Material

Polyurethane

Quantity

4 No.

Material

SS 304

Quantity

1 No.

Material

Nylon

Quantity

2 Nos.

Vacuum pump motor

Suction Cup

Good bad
sorting chute

Suction wheel

6.11 Sub assembly Name = Structure and drive

Manufacturer = Pam Pac Machines
Item Name

Description

Specification

Main frame

Material

M.S. fabrication
with paint

Cladding

Machine
mounts

Material

SS 304

Finish

Matt

Make

AVMEC

Type

AV 20

Quantity

4 Nos.

6.12 Sub assembly Name =Controls

Manufacturer = Pam Pac Machines
Item Name

Description

Specification

Power supply

Make

Sai Control

Voltage

24 V DC

Amp.

10 A

Quantity

1 No.

Make

Chaitanya

Voltage

415 V AC

Phase

1 Ph.

Output

220 to 240 Volts

Quantity

1 No.

Make

Datalogic

Model

TL 10

Quantity

1 No.

Make

B & R Automation

Type

4 D 1170 Touch screen

Make

B & R Automation

Type

C 221

Rating

4 I/O cards & 1 relay card

Make

B & R Automation

Model

ACOPOS 1090

Quantity

2 No.

Make

B & R Automation

Model

ACOPOS 1045

Quantity

1 No.

Make

B & R Automation

Model

ACOPOS 1022

Quantity

2 No.

Transformer

PRC Scanner

MMI

PLC

AC Drive

AC Drive

AC Drive

DETAILS OF UTILITIES

Equipment Name Blister Packing Machine

Equipment Model BQS
Following utilities are required
Sno.

Item

Specification

1.0

Compressed Air

Pressure 7 to 8 Kg / Sq.cm

( Dry )

Capacity 30 to 35 CFM.

Chilled water

Cooling Capacity -4500 KCAL / hr.

2.0

Temp. 18 to 20 Degree C
Flow rate 15-20 Liters / min.
3.0

Elect. Supply

415 V, 50 Hz.
Average 7 KW
Peak 14 KW.

4.0

Cable

5C X 6 Sq. Mm- Copper cable

4 Sq. mm

Remarks

 IDENTIFICATION OF COMPONENT FOR CALIBRATION

In the Thermoforming Blister Packing Machine model BQS, following are the components, which needs
calibration. They shall be calibrated during/ before installation of the equipment at the site.
Following are the components:
1. Temperature controller for sealing station
2. Temperature controller for forming station
3. Vibrator controller for linear vibrator
4. Vibrator controller for Rotary vibrator
5. Temperature controller (Heating plate top)
6. Temperature controller (Heating plate bottom)
7. Temperature sensor (Inlet water temp.)
8. Vacuum Gauge
9. All pressure gauge (main pressure)
MATERIAL OF CONSTRUCTION

S.NO

COMPONENT DESCRIPTION

MOC

1.

Main frame

M. S.

3.

Cladding covers

SS 304

4.

Hopper

S.S 316

5.

Distributor plate

SS 316

6.

Linear vibrator

SS 316

7.

Feeding sector

Al. Anodized

8.

Feeding

Al. Anodized

Channel
9.

Good Bad Sorting Chute

SS 304

SAFETY FEATURES AND ALARMS

Safety interlocks have been incorporate for :
The acrylic guards
The safety switches are provided for protection from the moving parts. In case any of the
above are opened in run mode the machine will immediately stop.
Provision of emergency stops
Emergency switches are provided at common working places of the machine on the MMI box.
All the electrical / electronics components are mounted in a fully enclosed cabinet. This provides
proper safety from live parts.
All components are having proper earthing.
Operator accessible area i.e. MMI, Console, safety interlocks, switches and sensors etc. Are given
24 VDC supply.
All moving parts are housed in an enclosed cabinet having two doors with locking arrangement and
safety interlock.
SAFETY FEATURES AND ALARMS IN RUN MODE

Sr.

Station

Fault

Reason for fault

Machine reaction

Sensor for

Foil end

Foil consumed /

Machine stops at zero

broken

position

Air pressure bellow 5

Machine stops at zero

Bar

position

No water supply

Machine stops at zero

No.
1

forming foil
2

Air pressure

Water pressure

Low air pressure

Low water
pressure

Machine guard

Guard open

position

Sr.

Station

Fault

Reason for fault

Machine reaction

Forming/sealing

Machine stops at zero

station guard not

position

No.

closed properly
5

Vacuum pump

Vacuum pump off

Vacuum pump shut off

Machine stops at zero

position

Low temp.-

Temp. is low

forming

When the actual

Machine stops at zero

temp.is less than 15

position

degree C.
7

Low temp.-

Temp. is low

sealing

When the actual

Machine stops at zero

temp.is less than 20

position

degree C.
8

High temp.-

Temp. is high

forming

When the actual

Machine stops at zero

temp.is more than 20

position

degree C.
9

High temp.-

Temp. is high

sealing

When the actual temp.

Machine stops at zero

is more than 20 degree

position

C.
10

Eye mark

Eye mark missing

(Optional )
11

Buzzer

Buzzer operates

Continues 5 eye mark

Machine stops at zero

not sensed by scanner

position

Continuously product

Buzzer operates

missing
12

13

Sealing

Thermocouple

Thermocouple is open

Machine stops at zero

thermocouple

open

for more than 3 min.

position

Sensor for lidding

Foil end

Foil consumed /

Machine stops at zero

broken when clutch is

position

foil

ON
14

Emergency off

Emergency off

Pressed Emergency

Machine stops instantly

push button
15

Water pressure

No heating, No

When water flow is off

water
16

Overload

Machine overload

Machine stops at zero

position

When there is

Machine stops at zero

mechanical load on the

position

machine
17

MCB

MCB Trip

Any MCB trip

Machine stops at zero

position

18

19

20

Air blowing

Air blows while machine

sealing

is in stopped condition

Air blowing

Air blows while machine

Punching

is in running condition

Indexing

Indexing overload

Web slipped during

Machine stops at zero

indexing and sensed

position

web

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. Functioning of Machine operating panel with MMI

2. Interlocks and safety features provided.

3. Details of major components fitted on the machine
4. Carry out product run and fill test criteria with product.
5. Check deficiency and corrective action taken report.
6. Fill up chart of pre-requisites of installation.
CHANGE CONTROL PROCEDURE:
Change in the agreed design shall be addressed through the well-defined Change control procedure.
DESIGN QUALIFICATION REPORT APPROVAL
LIST OF ABBREVIATIONS

cGMP

Current Good Manufacturing Practices

SOS

Scope of supply

FAT

Factory Acceptance Test

AC

Alternate Current.

MS

Mild steel

PLC

Programmable Logic Control

SS

Stainless Steel

MNP

Matt Nickel Plated

K.W.

Kilo Watt

DQ

Design Qualification

Hz

Heartz.

Kg

Kilogram.

FAT

Factory acceptance test

C.I.

Cast Iron

No.

Number

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China Paper Cup Making Machine. Good Price. Export Worldwide.

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