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Design Qualification of Blister Packing Machine (Model – BQS)

  • Design Qualification of Blister Packing Machine (Model – BQS)OBJECTIVE
  • To design, engineer, and supply the Blister Packing Machine  (Model: BQS) 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).  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
  • 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.  Blister Packing Machine  
Model  BQS
Type Thermoforming Blister Packing Machine
Dimension 4500L X 1900W X 2000H
Output 45 Cycles/min. for PVC/ALU forming

35 Cycles/min. for ALU/ALU forming

200 cycles / min. in punching station.

Forming area 240 x 180 mm

Max. Draw depth 12 mm

Max. Draw of Length 180 mm.

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

74 – 76 mm core dia.

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

74 – 76 mm core dia.

Part A = Bought out items
2.  Heating plate bottom
Plate Dimension 265 x 368 mm
Treatment Teflon coating
Thermocouple To be provided
Heater type Embedded type
Location Heating station
3. Pneumatic  Cylinder
Make Festo
Model ADVUP-40-P-A-25Z1-30Z2
P max 10 bar
Location Bottom  Heating Plate
4. Heating plate top
Plate Dimension 265 x 368 mm
Treatment Teflon coating
Thermocouple To be provided
Heater type Embedded type
Location Heating station
5. Pneumatic  Cylinder
Make Festo
Model ADVC – 32- 25 – I-P-A

188206T108

P max 10 bar
Location Top Heating Plate
6. Flow switch
Make IFM
Model SI1000

SID10ADBF PKG/US

7. Top plate
Plate Dimension 235 x 181 mm
Location Forming station
8.  Water Condensation Valve
Make Saimag
Type Diaphragm
Model DT-04
Size 1½”
9. Bottom plate
Plate Dimension 235 x 181 mm
Location Forming station
10. Hopper
MOC Stainless Steel 316
View Glass To be provided
Capacity 50 Ltrs.
Location Feeding
11. Level Sensor
Type Proximity
Location Rotary Vibrator
Make IFM
Rating 250 ma, 36 V DC
12. Linear vibrator
MOC Stainless Steel 316
Location Feeding
13.Distributor plate
MOC Stainless Steel 316
Location Feeding
14. Top plate
Plate Dimension 185 x 255 mm
Thermocouple To be provided
Location Sealing station
15. Pneumatic Cylinder
Make Festo
Model ADVC-40-25-I-P-A

188236T108

Pmax 10 bar
Location Top sealing plate
16. Locking Cylinder
Qty. 02 Nos.
Make Festo
Model ADVU-25-50-A-P-A

156615T123

Pmax 10 bar
Location Top sealing plate
17. Bottom plate
Plate Dimension 280 x 178 mm
Location Sealing station
18.Exhaust Fan
Model REC22038 AL
Power Rating 220 V, 50 Hz, 1 Amp.
Make Rexnord
Location Sealing Station
19. Emergency Switch
Location Punching and Perforation
20.Hydraulic Cylinder
Sr.No. 47762
Type FFCB4
Pmax 160 kg / cm2
Make Indian pneumatic and hydraulic co.
Location Bottom Sealing Plate
21. Pneumatic cylinder
Make Festo
Model ADVU-63-5-P-A

156007T123

Pmax 10 bar
Location Bottom cooling plate
22.              Door limit Switches
Qty. 06 Nos.
Model XCJ-110
Make Telemecanique
Rating 10 A, 240 V AC
Location Heating station / Forming station / Sealing station / Cooling station / Perforation and punching station / Material pickup
23. Good bad sorting chute
MOC Stainless Steel 304
Location Blister sorting station

Part B = Bought out items

Description Specification
1.  PVC Unwinding motor
Make Technocraft
Rating 0.15 HP
RPM 1400 RPM
Voltage 415 V
Phase 3 phase
Location PVC Unwinding station
2. Limit Switch
Make Telemacanique
Model XCJ-127
Rating 10A 240V AC
Location Near PVC unwinder
3.  Rubber ring
Material Silicon Rubber
Size 50 X 5
Location PVC Unwinding station
4. Joint detection sensor
Make Data Logic sensor
Model TL U11
Location Splicing station
5.Sensor for dancing lever
Type Inductive
Quantity 04
Model EGT12X02APO2

45000L

Make Tekeniceuchner
Location  PVC unwinding station (02 Nos.) Aluminium Foil unwinding station. (02 Nos.)
6.Heating Coil
Make Saket
Rating 2.5 KW
Location Heating station
7. Power Pack
 Make Zeon
Working pressure 160 Bar
8.Power Pack motor
Type 3 Phase induction
make Crompton Greaves
Motor Rating 5 HP
Sr. No. 2732DVJ / DLC 8744
Voltage 415 V AC
RPM 1430 RPM
Location Heating Station
9. Vibrator controller (Linear)
Make Sai control
Voltage 230 V
Rating 3 A
Location Control Panel
10. Vibrator controller (Rotary)
Make Sai control
Voltage 230 V
Rating 3 A
Location Control Panel
11. Servo motor
Make B & R Automation
Rating In 0.70A

Mn 0.6 Nm

Io  0.73A

Mo 0.6 Nm

Sr. No. 8MSA2L.RO-67

47630223183

Location Drum feeder
12. Motor for Al. Unwinding
Make Bharat Bijlee
Rating 0.25 HP
RPM 1350 RPM
Voltage 415 V AC
Phase 3 Phase
Location Al. Unwinding station

 

13. Proximity Switch  
Qty. 05 Nos.
Make Tekniceuchener
Model EGT 18 X 05 AP024-5000 L
Location Near Al. Unwinding Station / Perforation and punching / Drum feeder / Servo main motor / Pickup station
14.Proximity Switch
Qty. 02 Nos.
Make Telco
Model SMP8500PG2.5
Location Blister Discharge
15. Air Gun
Make Festo
Model LBP – ¼

3552858

Pmax 10 bar
16. Ink cartridge
Make Process instrumentation and control
Size Dia.50 X 245 Lg.
location Overprinting Station
17. Ink
Make Dolphin Ink (I)
Specification DIPL 39
Mixture 60% with thinner
location Overprinting Station
18. Thinner
Make Dolphin Ink (I)
Specification DIPL 20
Mixture 40% with ink
Location Overprinting station
19. Gear Box
Type VF-44-PMS
Make Bonfiglioli
Ratio 1 : 28
Location Printing
20. Servo Motor
Sr. No. 47630229690
Model 8MSA2L.RO-67

 

Make B & R Automation
Rating In 0.70A

Mn 0.6 Nm

Io 0.73A

Mo 0.6 Nm

Location Printing
21. Gear box
Make Bonfiglioli
Ratio 1:30
Location Pulling station
22. Servo motor
Sr. No. 42470229712
Model 8MSA4M.RO-31
Make B & R Automation
Rating In 3.75A

Mn 4.6 Nm

Io 4.10A

Mo 5.3 Nm

Location Pulling station
23. Gear box
Make Technocraft
Sr. No. 2K4-63-1205
Ratio 7.5 : 1
Location Punching and perforation
24. Servo motor
Sr. No. 42480229705
Model 8MSA4L.RO-31
Make B & R Automation
Rating In 4.35A

Mn 6.4 Nm

Io  4.80A

Mo 7.5 Nm

Location Punching and perforation
25. Vacuum pump
Make Indovac
Sr.No. 512030
Model IV500
Rating 2 HP, 1440 RPM
Capacity 500 LPM
Pressure 26” of  Hg.
Location Blister pick up station
26. Suction cup
Make IWKA
Material Polyurethene
Location Blister pick up station
27.Vacuum pump motor
Make Bhart Bijlee
Sr. No. N2439510
Supply voltage 415 V AC
Rating 2 HP
RPM 1415 RPM
Phase 3 Phase
Location Blister pick up station
28.Main motor
Sr.No. 54470229667
Model 8 MSA4L.EO.33
Make B & R Automation
Rating In 4.35 A

Io 4.80A

Mn 6.4 Nm

Mo 7.5 Nm

Location

Main drive

29.Machine mounts
Make AV Mount
Location Machine structure
30. Gear Box
Make Bonfiglioli
Ratio 1:30
Location Main drive
31.PRC Scanner
Make Data logic
Model TL 10
Specification PNP / 24 V DC
Location Print Registration
32. MMI
Make B & R Automation
Type 4 D 1170 Touch screen
Location Moveable
33. PLC
Make B & R Automation
Type C 221
Rating 4 I/O cards & 1 relay card
Location Electronic control
34.  AC Drive (Main Motor)
Make B & R Automation
Model ACOPOS 1090
Location Electronic control
35. AC Drive (Punching  Motor)
Make B & R Automation
Model ACOPOS 1090
Location Electronic control
36. AC Drive (Pulling  Motor)
Make B & R Automation
Model ACOPOS 1045
Location Electronic control
Make B & R Automation
Model ACOPOS 1022
Location Electronic control
37. AC Drive (Overprinting Motor)
Make B & R Automation
Model ACOPOS 1022
Location Electronic control
38. Pressure Gauge
Dial Size 1.75”
Model 356759R9
Range 0-16 bar
Make Festo
Service Main air pressure
39. Pressure Gauge
Dial Size 1.5”
Model 345395S4
Range 0-16 bar
Make Festo
Service Pick up
40. Pressure Gauge
Dial Size 1.5”
Model 345395S1
Range 0-16 bar
Make Festo
Service Flap for Alu/Alu
41.Pressure Gauge
Dial Size 1.5”
Model 345395S4
Range 0-16 bar
Make Festo
Service Cutting Rejection
42. Pressure Gauge
Dial Size 1.5”
Model 345395S4
Range 0-16 bar
Make Festo
Service Cooling Plate
43.Pressure Gauge
Dial Size 1.5”
Model 345395S4
Range 0-16 bar
Make Festo
Service Sealing station down (Top Cylinder)
44. Pressure Gauge
Dial Size 1.5”
Model 345395S4
Range 0-16 bar
Make Festo
Service Sealing station lock
45. Pressure Gauge
Dial Size 1.5”
Model 345395S4
Range 0-16 bar
Make Festo
Service Foil Brake
46. Pressure Gauge
Dial Size 1.5”
Model 345395S4
Range 0-16 bar
Make Festo
Service Foil Brake
47.  Pressure Gauge
Dial Size 1.75”
Model 356759R9
Range 0-16 bar
Make Festo
Service Air Reservoir pressure for forming
48. Pressure Gauge
Dial Size 1.5”
Model 345395S3
Range 0-16 bar
Make Festo
Service Main cam pressure
49. Pressure Gauge
Dial Size 1.5”
Model 345395S3
Range 0-16 bar
Make Festo
Service Heating Station pneumatic pressure
50. Pressure Gauge
Dial Size 1.5”
Model 345395S3
Range 0-16 bar
Make Festo
Service Main cam pressure
51. Pressure Gauge
Dial Size 1.5”
Model 345395S3
Range 0-16 bar
Make Festo
Service Product stopper
52. Pressure Gauge
Dial Size 1.5”
Model 345395S3
Range 0-16 bar
Make Festo
Service Product stopper
53.Pressure Gauge
Dial Size 2.5”
Model E9932
Range 0-280 kg / cm2
Make Shreeji
Service Main Hydraulic pressure
54. Pressure Gauge
Dial Size 2.5”
Model E9893
Range 0-280 kg / cm2
Make Shreeji
Service Accumulator Pressure
55.Pressure Gauge
Dial Size 4”
Model A60527
Range 0-281 kg / cm2
Make fgb
Service Oil pressure gauge
56. Vaccum pressure Gauge
Dial Size 2”
Model AL-01
Range 0 to -760 mm / hg
Service Vaccum Pressure
57.Temperature Gauge
Dial Size 2.5”
Model 1013-12-04
Range 0-100ºC
Make Shreeji
Service Hydraulic oil temperature
  • DETAILS OF UTILITIES

Equipment Name – Blister Packing Machine

Equipment Model – BQS

Following utilities are required

Sno. Item Specification Remarks
1.0 Compressed 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.

3.0 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. All pressure gauges
  2. Temperature gauge
  3. Vaccum gauge
  • MATERIAL OF CONSTRUCTION
S.NO COMPONENT DESCRIPTION MOC

 

1 Cladding covers SS 304
2 Hopper S.S 316
3 Distributor plate SS 316
4 Linear vibrator SS 316
5 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.

No.

Station Fault Reason for fault Machine reaction
1 Sensor for forming foil Foil end Foil consumed / broken Machine stops at zero position
2 Air pressure Low air pressure Air pressure bellow 5 Bar Machine stops at zero position
3 Water pressure Low water pressure No water supply Machine stops at zero position
4 Machine guard Guard open Forming/sealing station guard not closed properly Machine stops at zero position
5 Vacuum pump Vacuum pump off Vacuum pump shut off Machine stops at zero position
6 Low temp.- forming Temp. is low When the actual temp.is less than 15 degree C. Machine stops at zero position
7 Low temp.- sealing Temp. is low When the actual temp.is less than 20 degree C. Machine stops at zero position
8 High temp.- forming Temp. is high When the actual temp.is more than 20 degree C. Machine stops at zero position
9 High temp.- sealing Temp. is high When the actual temp. is more than 20 degree C. Machine stops at zero position
10 Eye mark

(Optional )

Eye mark missing Continues 5 eye mark not sensed by scanner Machine stops at zero position
11 Buzzer Buzzer operates Continuously product missing Buzzer operates
12 Sealing thermocouple Thermocouple open Thermocouple is open for more than 3 min. Machine stops at zero position
13 Sensor for lidding foil Foil end Foil consumed / broken when clutch is ON Machine stops at zero position
14 Emergency off Emergency off Pressed Emergency push button Machine stops instantly
15 Water pressure No heating, No water When water flow is off Machine stops at zero position
16 Overload Machine overload When there is mechanical load on the machine Machine stops at zero position
17 MCB MCB Trip Any MCB trip Machine stops at zero position
18 Air blowing – sealing Air blows while machine is in stopped condition
19 Air blowing – Punching Air blows while machine is in running condition
20 Indexing Indexing overload Web slipped during indexing and sensed web Machine 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
  • APPENDIX
    • 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
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
Date Revision Number Reason for Revision
00 New SOP

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