1. Objective
  2. Scope
  3. Responsibility (Client and manufacturer)
  4. Machine description
  5. Technical specifications and make of sub-components/ bought out items.
  6. Details of Utilities
  7. Identification of components for calibration
  8. Material of construction of all components
  9. Safety features and alarms
  10. FAT procedure
  11. Change control procedure
  12. Qualification Document report approval
  13. Appendix
  • To design, engineer, and supply the Cartoning Machine HI CART (Blister Packing) 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.
  • The scope of this qualification document is limited to the Design Qualification of  Cartoning Machine HI CART (Blister Packing). This qualification document is part of a validation activity for the Cartoning Machine HI CART (Blister Packing).
  • SCOPE:
    • CLIENT
      • To check and approve the design qualification.
      • 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.
    • Purpose of Machine
    • The purpose of the cartoning machine is to carton pack, unit products automatically into cardboard cartons.
  • The machine performs following functions:
  • Storing of pre-broken cartons in flat form in the carton magazine.
  • Picking up the cartons from carton magazine.
  • Opening / erecting the carton.
  • Closing one side.
  • Loading Leaflet.
  • Loading product
  • Closing other side.
  • The machine consists of following main stations:
  • Carton loading magazine.
  • Carton pick up.
  • Carton chain.
  • Leaflet chain.
  • Product chain.
  • Product transfer mechanism.
  • Carton Loading magazine
  • This consists of adjustable guides in which different sizes of pre-broken cartons can be loaded.  The guide adjustment is to be done manually, with the help of handles.
  • Carton Pick up
  • This arrangement picks up the carton from loading magazine and transfers it on the carton chain.  Cartons are picked up with help of vacuum.  Carton is not picked up if product or leaflet is missed out.  This consists rotary drum pick up sucker arm, vacuum pump and vacuum valve.
  • Carton Chain
  • Carton chain holds and carries the carton while it gets opened, filled and closed.  This is continuous motion chain.  The carton opening and closing linkages operate in synchronisation with chain movement.  The chain is in two sections, one fixed and other adjustable.  This adjustment takes care of different carton widths.
  • The chain carries in 3 versions, two chain, three chain and four chain.  These 3 types are based on the 3 ranges of carton it can handle once the machine is built for a carton type (i.e. 2 chain or 3 chain or 4 chain) it can handle that range of cartons only.  The machine can not be converted to other type of chain configuration.   The subject machine is 3 chain machine.
  • Product chain
  • Products to be packed are carried on this continuously running chain and they are loaded into carton at the pusher station.
  • The chain has pocket angles (cell angles) mounted on it.  The product is carried between these angles.  The distance between the cell angles is adjustable to handle various widths of product.
  • All automatic product transfer mechanisms are mounted along this chain.
  • The product chain also is made in two sections, one fixed and the other adjustable.
  • Carton discharge
  • After the carton is closed, the same is carried between two belts and discharged.  This can be collected in a bin or a conveyor.
  • Empty carton rejection system –
  • This system is provided to detect and reject the empty cartons from the line. A sensor senses the product presence in the carton.  If the product is found missing in any carton, that particular carton will be ejected with the help of pneumatic cylinder and prevented from going into production line.  This ejected carton is collected in separate bin.
  • Embossing station
  • This station is used to give batch code embossing provision on the carton. The metallic stereos are fixed on the stereo roller and carton flap is passed through the stereo roller and pressure roller to get the impressions of stereos on the carton flap.
  • Leaflet folding and transfer
  • This attachment is provided to fold a flat leaflet and insert it into the carton.  This station is provided after closing the bottom flaps and before loading the product into the cartons.  There are folding plates and turning plates in the leaflet folding machine with which number of folds can be done as per specifications of customer and agreed by vandor. After folding, the leaflets are carried by belts and inserted into the cartons.  The synchronisation of folding unit to cartoning machine is done.
  • PLC Description
  • This is operator control panel for operating various systems like mode selector key (inch / run), vacuum pumps and monitoring and setting the various parameters.
  • Model – FX on 40MT-DSS, 24 inputs & 16 outputs, Mitsubishi, Japan ,All inputs are 24 VDC supply.
  • MMI DETAILS:Model – E300
  • Make- Beijers, Sweden. (Supplied by Mitsubishi)
  • Input supply – 24 VDC +/- 10%
  • Display – 4 line display

Operator panel developed to satisfy the demand made for operator and machine communication.  The various devices can be monitor and PLC data changed through the screens in E100.  It is equipped with dynamic indication alarm .

Description Specification
Type Continuous motion automatic cartoning machine
Dimension 5108mmx1657mmx2100mm


Carton size range  
Width 20mm to 75mm
Height 14mm to 65mm
Length 65 mm to 180 mm
Leaflet size range (unfolded)
Width 110 to 170
Length 80   to   240
Leaflet GSM 45   to   60
Output  25   to 220 Cartons / min
Carton closure Reverse tuck in
Carton GSM 280  to  400
Overprinting Overprinting /embossing is possible only on main flap rear
 Embossing Maximum number of letters possible in one line is 15 (size 1.59) Lines possible is 4.
Description Specification
1.                  Cell angle
Material Aluminium
Location Conveyor Chain
2.                  Straight knurling roller
Qty. 04 Nos.
Location Leaflet folding
3.                  Pressure roller
Qty. 04 Nos.
Location Leaflet folding
4.                  Ink carrying roller
Material Neoprene rubber


Overprinting & Embossing Station
  • Part B = Sub-Components / bought out items
Description Specification
1.                  Main geared motor
Make Bonfliglioli
Type 3 Phase Induction Motor
Model BN90LA4
Voltage 415V
Power 1.5 kw
Location Structure and drive
2.                  Gear box
Make Bonfliglioli
Type MAS251P
Ratio 10:53
Location Structure and drive
3.                  Product chain
Size 1/2 ”
Location Structure and drive
4.                  Carton chain
Size 1”
Location Structure and drive
5.                  Machine Mount
Make Av Mount
Type M12
Description Specification
Location Structure and Drive
6.                  Vacuum pump
Make Indovac
Sr. No. 532074
Description Specification
Rating 1 HP
RPM 1440 rpm
Vaccum 26” Hg
Capacity 300 LPM
Location Carton pickup & Transfer & Pre breaking
7.                  Vacuum Pump Motor
Make Siemens
Sr. No. 0505045015
Motor Rating 0.75 KW
Type 3 Phase Induction
Voltage 380-415 V AC
RPM 1415 rpm
Location Carton Pickup & Transfer & Pre breaking
8.                  Vacuum pump
Make Indovac
Sr. No. 4121950
Rating 2 HP
RPM 1440 rpm
Description Specification
Vaccum 26” Hg
Capacity 500 LPM
Location Carton pickup & Transfer & Pre breaking
9.                  Vacuum pump motor
Motor make Siemens
Sr. No. 0410029290
Motor Rating 1 .5 KW
Type 3 Phase Induction
Description Specification
Voltage 415 V AC
RPM 1415 rpm
Location Carton Pickup & Transfer & Prebreaking
10.              Sucker for Carton Pick Up
Qty 06 Nos.
Location Carton Pickup & Transfer
11.              Sucker for Carton Prebreaking
Qty. 02 Nos.
Location Prebreaking
12.              Solenoid Valve
Make Legris
Capacity 1.59-9 bar
Description Specification
Location Product Pushing
13.              Chain Plate (Small without thread)
Make Ambika
Material Derlin Gray Colour
Location Product Pushing
14.              Vacuum Pump
Make Indovac
Sr. No. 512027
RPM 1440 rpm
Rating 1 HP
Description Specification
Capacity 300 LPM
Vacuum 26” Hg.
Location Leaflet Folding
15.              Vacuum Pump Motor
Motor make Bharat Bijlee
Sr. No. N2434687
Motor Rating 1 HP
Type 3 Phase Sq. Cage Induction Motor
Voltage 373- 456V AC
RPM 1405 rpm
Location Leaflet Folding
16.              Belt For Leaflet Transfer
Make Habasit
Size 12.5 x 0.645 mm
Location Leaflet Folding
17.              chain for leaflet clamp
Size 1/ 2”
Location Leaflet Folding
18.              Ink
Make Aditya system
Specification A-50
Location Overprinting & embossing unit.
19.              Cylinder for Ejection
Make Festo
Model 91265D23
P max 8  bar
Description Specification
Range 16 x 50
Location Empty carton rejection
20.              Solenoid valve
Description Specification
Make Legris
Pressure 1.59-9 bar
Location Empty carton Rejection
21.              Discharge Belt
Make Habasit
size 30×110
Location Empty Carton Rejection
22.              A.C Drive
Make Mitsubishi E500
Model FR-E540-1.5 k
Location Controls
23.              Single phase preventor
Make Minilec
Sr. No. 4U3717
Model ALV-DL
Rating 380-440 VAC
Location Controls
24.              Power supply
Make NHP
Sr. No. 100105
Voltage O/P 24 V – 10A
25.              P.L.C.
Location Controls
Make Mitsubishi
Type FX ON  –40 MT –DSS
Location Controls
Description Specification
26.              M.M.I.
Make Bejers-Sweeden
Type E 300
Location Controls
27.              Encoder
Make Raj Deep
28.              Pressure Gauge
Make Legris
Dial Size 1.5”
Range 0-10 kg / cm2
Location FRL unit / Pressure Regulator Unit
Qty.  2 Nos.
29.              Pressure Switch
Make Orion
Model MEH07CB10
Sr. No. A05010548
Location Machine Base
Qty. 2 Nos.
30.              Vacuum Gauge
Type AL01
Range 0 to -760 mmhg
Location Vaccum Pumps
Qty. 3 Nos.
Description Specification
31.              Blister Check Sensor
Make IFM
Qty. 02 Nos.
Rating 36 V / DC
Sr. No. 0G50430GEFPKG/US


Description Specification
32.              Leaflet Check Sensor
Make IFM
Sr. No. 0G50530GH-FPKG/US
33.              Carton Check Sensor
Make IFM
Sr. No. 0G50530GH-FPKG/US
34.              Carton Level Sensor
Make IFM
Sr. No. 0G50530GH-FPKG/US
35.              Check Sensor for empty Carton
Make IFM
Sr. No. 0G50530GH-FPKG/US
36.              Blister Check Sensor for Empty Carton
Make IFM
37.              Arm Rotation Sensor/ Liver Check Sensor
Make IFM
Description Specification
Sr. No. AP024-5000L
38.              Ganter Reading Knobs
Qty. 20 Nos.
Make Raj Deep
Location 04 (Mazzine) / 08 (Front Side Closing) / 08 (Rear Side Closing)
39.              Cooling Fan
Make Rexnord
Model REC2203882
Location Control Panel
  •  Details of utilities 
Description Specifications
 6.1 Electrical
Phase 3 Phase
Voltage 415V
Frequency 50 Hz
 6.2 Compressed Air
Flow pressure 6 bar
Quality Oil, water and dust free
Max. consumption 1 cfm

In the Cartoning Machine HI CART (Blister Packing), following components need calibration. They shall be calibrated during/ before installation of the equipment at the site:

  1. Vacuum Gauge (Carton pickup, transfer & prebreaking)
  2. Vacuum Gauge
  3. (Carton pickup, transfer & prebreaking)
  4. Vacuum Gauge (Leaflet folding)
  5. Pressure Gauge (2 Nos.)
Description Specification Meets

Spec. Yes/No

Verification Source Initials Date
Cladding SS 304
Carrier angle S.S. 304
Blister magazine SS 304 Sheet
Control panel and operating panel S.S 304
Carton guides  S.S.  Buffed
Flap closers S.S. Buffed
  • All the electrical components, which are having high voltage, are covered with proper cover.
  • All the electrical / electronics components are mounted in a fully enclosed cabinet. This provides proper safety from live parts.
  • All moving parts are covered with proper guards with interlocks for some guards.
  • All necessary guards are provided with safety switches interlocks. In case of removal of the guard, the machine will stop instantly.
  • Two emergency switches are provided in the machine, one at operator panel and other at discharge end of the machine.  Once it is pressed, machine will stop instantly.
  • Overload interlock is provided at pusher station.In case of any jamming during pushing, this interlock will actuate and machine will stop instantly.
  • All motors are connected through overload relays.In case of overload or jamming in the motor side or drive side, this relay will trip the motor and machine.
  • Any of the electrical phase failure or phase disconnection, single phase disconnection, single phase preventor unit will trip the machine instantly.
  • All electrical parts and full machine are earthed properly.
  • Operator handling areas such as sensors, operator panel, switches etc. are having low voltage (i.e. 24 VDC).
  • Prevention of oil contamination with product.
  • All main drive element e.g. motor and gearbox are mounted on machine base which is well below product chain and carton chain.
  • All the drive transmission parts such as chains and sprockets fall below the product and carton chain level.
  • Since the lubrication is not forced, the oil travelling upward is technically not possible hence oil contaminating the carton/product is not possible.

Primary pack contact surfaces:

  1. Following are components which come in contact with product the primary pack :
    • Blister magazine: SS 304 Sheet Polished surface
    • Cell angle: Aluminium   Buffed
    • Chain plate: Delrin
    • Pusher: Aluminium Anodised
  2. Following are components which come in contact with carton:
    • Carton magazine: S. Bright Nickel plated
    • Carton guides: S.  Buffed
    • Flap closers: S. Buffed
    • Carton chain: S.  Bright nickel-plated
    • Discharge conveyor belt: Rubber PU coated
Sr. No. Fault Alarm
1. Air Pressure Minimum If the air pressure drops below the minimum set level(5 bar), then this alarm will trip the machine and will display “LOW AIR PRESSURE”.
2. Empty Carton Magazine If Carton level in the magazine is reduced, the machine will stop and will display message “LOW CARTON LEVEL  ”
3. Machine Guards open If machine guards are opened during running OR are not closed properly machine will stop giving message “GUARD OPEN”
4. Emergency OFF is pressed When emergency stop is pressed machine will stop instantly indicating “EMERGENCY OFF” message.
5. Hand wheel out If hand wheel is out machine will not start   giving “HANDWHEEL OUT” message.
6. No product No Carton If there is no product in any of the pocket in product chain, the same is sensed and the machine does not pick up the carton corresponding to that pocket.
7. No Leaflet, No Carton If a leaflet is not picked up then corresponding carton is also not picked up.
8. No Product, No leaflet No leaflet is picked up for a pocket if product is not present in that pocket.
9. Jamming during pushing. Overload interlock is provided at pusher station.  Incase of any jamming during pushing, this interlock will actuate and machine will stop instantly.


10. Vacuum Pump If vacuum pump is not working , the mahine will not start.

Factory Acceptance Test Procedure shall be as follows:

After the completion of erection work of the machine, client shall be requested 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 in the agreed design shall be addressed through the well-defined Change control procedure.
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 Hertz.
Kg Kilogram.
MMI Man Machine Interface
C.I. Cast Iron
No. Number
UHMWPE Ultra high molecular weight polyethylene


About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He 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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