DQ of Blister Packing Machine (BQS)

TABLE OF CONTENT

  • Objective
  • Scope
  • Responsibility
  • Machine description
  • Technical specification
  • Technical specifications and make of sub-components/ bought out items.
  • Details of Utilities
  • 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
  • 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.
        • 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-Pac’s 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 FormingForming Temp RangePressure
Compressed air forming110   –  1304 -6  Bar Pressure
Plug assist air Forming85  –  1104- 6   Bar Pressure

 TECHNICAL SPECIFICATIONS

DescriptionSpecification
1.  Model BQS
2. TypeThermoforming Blister Packing Machine
3. Weight
Basic machine2500 kg approx.
Packing case3400 kg approx.
4. Dimension4500L 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 area240 x 180 mm

Max. Draw depth 12 mm

Max. Draw of Length 180 mm.

7. Max. Roll Diameter (Forming Film)450 mm x 252 mm width

74 – 76 mm core dia.

8. Max. Roll Diameter (Lidding Foil)250 mm x 246 mm width

74 – 76 mm core dia.

9. Suitable Working   Temperature range5 to 40 Degree C.

 

10. Noise Level  70 db (approx.)

 

11. Suitable Humidity range for the machine40 – 70 %
12. Electrical Supply   RequirementSupply Voltage: 415 V AC +/- 10% Phase + Earth

Supply Frequency: 50 Hz +/- 2%

Power Consumption: Average: 7 KW

Peak: 14 KW.

13. Compressed Air Requirement30-35 CFM at 7-8 bar near the machine.

 

14. Water requirementChilled 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 DescriptionSpecification
PVC

Unwinding motor

MakeTechnocraft
HP0.15 HP
RPM1400 RPM
Voltage415 V AC
Phase Three Ph.
Quantity1 No.
Rubber ringMaterialSilicon Rubber
Size50 X 5
Quantity2 Nos.
Base foil Joint Detection SensorMakeDatalogic
ModelTL 10
SpecificationPNP / 24 V DC
Quantity1 No.
Sensor for Dancing leverTypeInductive
SpecificationM10
Quantity2 No.

 

6.2     Sub assembly Name = Heating station
Item Name DescriptionSpecification
Heating Plate (Bottom)MaterialAl. Casting (LM 9)
TreatmentTeflon coating
Quantity1No.
Heating plate topMaterialAl. Casting (LM 9)
WattW
Quantity1No.
Pneumatic Cylinder

(Tendom)

MakeFesto
Size 25 x 30
Quantity1 No.
Pneumatic CylinderMakeFesto
Size50 x 25
Quantity1 No.

 

6.3     Sub assembly Name = Forming station

          Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Top PlateMaterialLM 6 ( Alloy )
Treatment Anodizing
Quantity1 No.
Bottom PlateMaterialIS 734 Al. Alloy
Treatment Anodizing
Quantity1 No.
Power packMakeZeon Make
Working pressure160 Bar
Motor makeBharat Bijali
Motor HP5 HP
Phase3 Ph.
Voltage415 V AC
RPM1440 RPM
Quantity1 No.
Hydraulic

Valve

MakeCETOP
Voltage24 V
Quantity1 No.
Hydraulic

Cylinder

Part No.GPP 726
MakeIPH
SizeDia. 80×15
Quantity1 No.
HopperMaterialSS 316
FinishBuffed RA 0.2
Capacity50 Ltrs.
Quantity1 No.
Linear

Vibrator

MaterialSS 316
FinishBuffed RA 0.2
Quantity1 No.

 

Item Name DescriptionSpecification
Vibrator

Controller

( Linear )

MakeSai Control
Voltage230 V 3 A
Quantity1 No.
Vibrator

Controller

( Rotary )

MakeSai Control
Voltage230 V 3 A
Quantity1 No.
Vibrator

Coil

( Linear )

MakeJadhav Brothers
Voltage230 V
Watt180 W
Quantity

 

1 No.
Vibrator

Coil

( Rotary )

MakeFeedtech
Voltage230 V
Watt180 W
Quantity1 No.
Distributor

plate

MaterialSS 316
FinishMatt
Quantity1 No.
Vibrator

Strips

Material58 CRV 4
Hardness40 – 45 HRC
TreatmentBlackodising
Quantity04   No.
  Aiuminium Roll unwinding MotorMakeSiemens
HP0.25 HP
RPM1380 RPM
Voltage415 V AC
Phase3 Ph.
Quantity1 No.
Gear for

unwinding

MaterialHylum
Quantity1 No.

 

6.4     Sub assembly Name = Sealing station

         Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Top Plate

 

 

MaterialAl-H 20 T 6
TreatmentAnodizing
Quantity1 No.
Bottom plate

 

MaterialAl-H 20 T 6
Treatment Anodizing
Quantity1 No.
Power pack

 

MakeZeon
Working pressure160 Bar
Motor makeBharat Bijali
Motor HP5 HP
Phase3 Ph.
Voltage415 V AC
RPM1440 RPM
Quantity1 No.
Hydraulic

valve

 

 

MakeCETOP
Voltage24 V
Quantity1 No.
Heater plateMaterialLM-9
Hardness120 BHN
TreatmentGBB
Quantity1 No.
Hydraulic

Cylinder

Part No.GPP726
MakeIPH
SizeDia. 80 x 15
Quantity1 No.

 

6.5    Sub assembly Name = Cooling station    

          Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Bracket

 

 

 

MaterialLM 16
Hardness90-100 BHN
TreatmentGBB
Quantity1 No.
Top PlateMaterialH9 T6
TreatmentGBB
Quantity1.No.
Bottom plate

 

 

MaterialH9 T6
TreatmentGBB
Quantity1 No.
6.6     Sub assembly Name = Overprinting station (Optional)

          Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Ink Cartridge

 

 

SizeDia.50 X 245 Lg.
Ink typeDIPL 39
Thinner typeDIPL 20
Quantity1 No.
Pressure

roller

MaterialM. S.
TreatmentBNP
Quantity1 No.

 

6.7    Sub assembly Name = Web Pulling station

          Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Pulling disc

Front

 

 

MaterialHC HCr
Hardness45 – 50 HRC
TreatmentBlackodizing
Quantity1 No.
 

Pulling disc

rear

 

 

MaterialHC HCr
Hardness45 – 50 HRC
TreatmentBlackodizing
Quantity1 No.
Gear Box

 

MakeBonfiglioli
Ratio1:30
Quantity1 No.
Servo motor

 

 

MakeB&R Automation
Torque5.3 Nm
Quantity1 No.
Bearings

 

 

 

MakeSKF
Specification6006 ZZ
Quantity2 No.

 

6.8     Sub assembly Name = Punching and perforation station

          Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Gear Box

 

MakeTechnocraft
Ratio7.5:1
Quantity1 No.
Servo motor

 

 

MakeB&R Automation
Torque7.5 Nm
Quantity1 No.
Cutting plate

(change part)

 

 

Part No.N.A. (Change part)
MaterialHCHCr
Hardness58-60 HRC
TreatmentBlackodising
Quantity1 No.
Punch

(change part)

 

 

 

Part No.N.A. (Change part )
MaterialHCHCr
Hardness58-60 HRC
TreatmentBlackodising
Quantity1 No. (Depends)
Change gear

(Change part)

 

 

 

Part No.N.A. (Change part )
MaterialEN8 / SAE 8620
Hardness55-60 HRC
TreatmentBlackodising
Quantity1 No.

 

6.9     Sub assembly Name = Punching and perforation station

          Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Moving plate

(Change part)

 

 

MaterialEN-8
TreatmentBlackodising
Quantity1 No.
Sliding plate

(Change part)

Part No.N.A.(Change part )
MaterialM.S.
TreatmentBlackodising
Quantity1 No.
Support plate

(Change part)

Part No.N.A.(Change part )
MaterialH9 T6
TreatmentAnodized
Quantity2 No.

 

6.10   Sub assembly Name = Pick up station

          Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Vacuum pump

 

 

MakeIndovac
Capacity500 LPM
Pressure25 ” of Hg.
Quantity1 No.
Vacuum pump motorMakeHindustan
Supply voltage415 V AC
HP2 HP
RPM1410 RPM
Phase3 Ph.
Quantity1 No.
Suction Cup

 

MakeIWKA
MaterialPolyurethane
Quantity4 No.
Good bad

sorting chute

 

MaterialSS 304
Quantity1 No.
Suction wheelMaterialNylon
Quantity2 Nos.

 

6.11   Sub assembly Name = Structure and drive

          Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Main frame

 

Material

 

M.S. fabrication

with paint

Cladding

 

MaterialSS 304
FinishMatt
Machine

mounts

 

 

MakeAVMEC
TypeAV 20
Quantity4 Nos.

 

6.12   Sub assembly Name =Controls

          Manufacturer = Pam Pac Machines

Item Name DescriptionSpecification
Power supply

 

MakeSai Control
Voltage24 V DC
Amp.10  A
Quantity1 No.
Transformer

 

 

 

 

MakeChaitanya
Voltage415 V AC
Phase1 Ph.
Output220 to 240 Volts
Quantity1 No.
PRC Scanner

 

 

 

MakeDatalogic
ModelTL 10
Quantity1 No.
MMIMakeB & R Automation
Type4 D 1170 Touch screen
PLCMakeB & R Automation
TypeC 221
Rating4 I/O cards & 1 relay card
AC DriveMakeB & R Automation
ModelACOPOS 1090
Quantity2 No.
AC DriveMakeB & R Automation
ModelACOPOS 1045
Quantity1 No.
AC DriveMakeB & R Automation
ModelACOPOS 1022
Quantity2 No.

 

  • DETAILS OF UTILITIES

 Equipment Name – Blister Packing Machine

Equipment Model – BQS

Following utilities are required

Sno.ItemSpecificationRemarks
1.0Compressed Air

( Dry )

Pressure – 7 to 8 Kg / Sq.cm

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.

3.0Elect. Supply415 V, 50 Hz.

Average 7 KW

Peak 14 KW.

4.0Cable5C 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.NOCOMPONENT DESCRIPTIONMOC

 

1.Main frameM. S.
3.Cladding coversSS 304
4.HopperS.S 316
5.Distributor plateSS 316
6.Linear vibratorSS 316
7.Feeding sectorAl. Anodized
8.Feeding

Channel

Al. Anodized
9.Good Bad Sorting ChuteSS 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.

No.

StationFaultReason for faultMachine reaction
1Sensor for forming foilFoil endFoil consumed / brokenMachine stops at zero position
2Air pressureLow air pressureAir pressure bellow 5 BarMachine stops at zero position
3Water pressureLow water pressureNo water supplyMachine stops at zero position
4Machine guardGuard openForming/sealing station guard not closed properlyMachine stops at zero position
5Vacuum pumpVacuum pump offVacuum pump shut offMachine stops at zero position
6Low temp.- formingTemp. is lowWhen the actual temp.is less than 15 degree C.Machine stops at zero position
7Low temp.- sealingTemp. is lowWhen the actual temp.is less than 20 degree C.Machine stops at zero position
8High temp.- formingTemp. is highWhen the actual temp.is more than 20 degree C.Machine stops at zero position
9High temp.- sealingTemp. is highWhen the actual temp. is more than 20 degree C.Machine stops at zero position
10Eye mark

(Optional )

Eye mark missingContinues 5 eye mark not sensed by scannerMachine stops at zero position
11BuzzerBuzzer operatesContinuously product missingBuzzer operates
12Sealing thermocoupleThermocouple openThermocouple is open for more than 3 min.Machine stops at zero position
13Sensor for lidding foilFoil endFoil consumed / broken when clutch is ONMachine stops at zero position
14Emergency offEmergency offPressed Emergency push buttonMachine stops instantly
15Water pressureNo heating, No waterWhen water flow is offMachine stops at zero position
16OverloadMachine overloadWhen there is mechanical load on the machineMachine stops at zero position
17MCBMCB TripAny MCB tripMachine stops at zero position
18Air blowing – sealingAir blows while machine is in stopped condition
19Air blowing – PunchingAir blows while machine is in running condition
20IndexingIndexing overloadWeb slipped during indexing and sensed webMachine stops at zero position

  

  • 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
SOSScope of supply
FATFactory Acceptance Test
ACAlternate Current.
MSMild steel
PLCProgrammable Logic Control
SSStainless Steel
MNPMatt Nickel Plated
K.W.Kilo Watt
DQDesign Qualification
HzHeartz.
KgKilogram.
FATFactory acceptance test
C.I.Cast Iron
No.Number

 

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About Pharmaceutical Guidanace

Alice is the Author and founder of pharmaceutical guidance, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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