Вы находитесь на странице: 1из 15

September 7, 2016 LATEST NEWS Performance Qualification Protocol of Tunnel Sterilizer Search...

Home Production QA & QC Engineering Warehouse Validation & Qualification Media And Video Guideline Contact Us Jobs

YOU ARE AT: Home Validation & Qualification Other DQ of Blister Packing Machine (BQS)

FOR FREE UPDATE

Email *

Subscribe

DQ of Blister Packing Machine (BQS) 0

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 Like Page Share

Appendix
Be the first of your friends to like this
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
FIND US ON GOOGLE PLUS
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.
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. Pharmaceutical Guidance
To confirm the safe delivery of the equipment to the user site.
Seguir
To ensure that no un-authorized and / or unrecorded design modifications shall take
92 seguidores
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).
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.

Rubber ring Material Silicon Rubber

Size 50 X 5

Quantity 2 Nos.

Base foil Joint Make Datalogic


Detection Sensor
Model TL 10

Specification PNP / 24 V DC

Quantity 1 No.

Sensor for Dancing Type Inductive


lever
Specification M10

Quantity 2 No.

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 W

Quantity 1No.

Pneumatic Cylinder Make Festo


(Tendom) Size 25 x 30

Quantity 1 No.

Pneumatic Cylinder Make Festo

Size 50 x 25

Quantity 1 No.

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.

Bottom Plate Material IS 734 Al. Alloy

Treatment Anodizing

Quantity 1 No.

Power pack 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.

Hopper 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


Controller
( Linear ) Voltage 230 V 3 A

Quantity 1 No.

Vibrator Make Sai Control


Controller Voltage 230 V 3 A
( Rotary )
Quantity 1 No.

Vibrator Make Jadhav Brothers


Coil Voltage 230 V
( Linear )
Watt 180 W

Quantity 1 No.

Vibrator Make Feedtech


Coil Voltage 230 V
( Rotary )
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.

Aiuminium Roll Make Siemens


unwinding Motor
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.

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.

Bottom plate Material Al-H 20 T 6

Treatment Anodizing

Quantity 1 No.

Power pack Make Zeon

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.

Heater plate 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.

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.

Top Plate Material H9 T6

Treatment GBB

Quantity 1.No.

Bottom plate Material H9 T6

Treatment GBB

Quantity 1 No.

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
Quantity 1 No.

Material HC HCr
Pulling disc Hardness 45 50 HRC
rear
Treatment Blackodizing

Quantity 1 No.

Gear Box Make Bonfiglioli

Ratio 1:30

Quantity 1 No.

Servo motor Make B&R Automation

Torque 5.3 Nm

Quantity 1 No.

Bearings Make SKF

Specification 6006 ZZ

Quantity 2 No.

6.8 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.

Servo motor 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.

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.

Vacuum pump motor Make Hindustan

Supply voltage 415 V AC

HP 2 HP

RPM 1410 RPM

Phase 3 Ph.

Quantity 1 No.

Suction Cup Make IWKA

Material Polyurethane

Quantity 4 No.

Good bad Material SS 304


sorting chute
Quantity 1 No.

Suction wheel Material Nylon

Quantity 2 Nos.

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 Material SS 304

Finish Matt

Machine Make AVMEC


mounts
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.

Transformer Make Chaitanya

Voltage 415 V AC

Phase 1 Ph.

Output 220 to 240 Volts

Quantity 1 No.

PRC Scanner Make Datalogic

Model TL 10

Quantity 1 No.

MMI Make B & R Automation

Type 4 D 1170 Touch screen

PLC Make B & R Automation

Type C 221

Rating 4 I/O cards & 1 relay card

AC Drive Make B & R Automation

Model ACOPOS 1090

Quantity 2 No.

AC Drive Make B & R Automation

Model ACOPOS 1045

Quantity 1 No.

AC Drive Make B & R Automation

Model ACOPOS 1022

Quantity 2 No.

DETAILS OF UTILITIES

Equipment Name Blister Packing Machine


Equipment Model BQS
Following utilities are required

Sno. Item Specification Remarks

1.0 Compressed Air Pressure 7 to 8 Kg / Sq.cm


( Dry ) Capacity 30 to 35 CFM.

2.0 Chilled water Cooling Capacity -4500 KCAL / hr.


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
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


No.

1 Sensor for Foil end Foil consumed / Machine stops at zero


forming foil broken position

2 Air pressure Low air pressure Air pressure bellow 5 Machine stops at zero
Bar position

3 Water pressure Low water No water supply Machine stops at zero


pressure position

4 Machine guard Guard open


Sr. Station Fault Reason for fault Machine reaction
No.

Forming/sealing Machine stops at zero


station guard not position
closed properly

5 Vacuum pump Vacuum pump off Vacuum pump shut off Machine stops at zero
position

6 Low temp.- Temp. is low When the actual Machine stops at zero
forming temp.is less than 15 position
degree C.

7 Low temp.- Temp. is low When the actual Machine stops at zero
sealing temp.is less than 20 position
degree C.

8 High temp.- Temp. is high When the actual Machine stops at zero
forming temp.is more than 20 position
degree C.

9 High temp.- Temp. is high When the actual temp. Machine stops at zero
sealing is more than 20 degree position
C.

10 Eye mark Eye mark missing Continues 5 eye mark Machine stops at zero
(Optional ) not sensed by scanner position

11 Buzzer Buzzer operates Continuously product Buzzer operates


missing

12 Sealing Thermocouple Thermocouple is open Machine stops at zero


thermocouple open for more than 3 min. position

13 Sensor for lidding Foil end Foil consumed / Machine stops at zero
foil broken when clutch is position
ON

14 Emergency off Emergency off Pressed Emergency Machine stops instantly


push button

15 Water pressure No heating, No When water flow is off Machine stops at zero
water position

16 Overload Machine overload 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 Air blowing Air blows while machine


sealing is in stopped condition

19 Air blowing Air blows while machine


Punching is in running condition

20 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

Sharing

Paper Cup Making Machine


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

ABOUT AUTHOR

PHARMACEUTICAL GUIDANACE

RELATED POSTS

SEPTEMBER 3, 2016 1 AUGUST 22, 2016 0 AUGUST 21, 2016 2

Performance Qualification DESIGN QUALIFICATION OF BIN DESIGN QUALIFICATION


Protocol of Tunnel Sterilizer WASHING & DRYING SYSTEM CARTONING MACHINE HI CART
(BLISTER PACKING)
LEAVE A REPLY

Your Comment

Your Name

Your Email

Your Website

POST COMMENT

GO BACK

ABOUT RECENT POST SHARING

Pharmaceutical Guidance Performance Qualification Protocol of Tunnel Sterilizer

SOP on Quality Risk Management


Pharma Guidance is Indias online complete Pharma
solution platform, where people can connect with each
other to share knowledge, buy the required Pharma
related Document .The vision is to support the all
manufacturers of pharmaceutical company to prepared
the current and update document to complies the cGMP
norms and also give the updated knowledge to new
Pharma beginner.

Copyright 2016 - Pharmaceutical Guidance by Sainssoft Technology