DESIGN QUALIFICATION (DQ) of Blister Packing Machine (BQS)

Blister Packing Machine (BQS)

The Blister Packing Machine consists of the following major stations

Forming foil unwinding station

This station is provided for various types of forming foils like PVC, PVDC, Alu-Alu, etc. The foil is clamped by the leading screw. The center distance concerning the base plate face is 170 mm, which can be maintained with the help of an adjusting screw. The tension on the foil can be adjusted by the spring provided from the backside. The foil unwinding operation is carried out with the help of a separate drive motor. To have a constant pressure on the foil operating of the 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 the 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 a paper-knife and joined with the help of adhesive tape. The joint detection sensor is provided which senses the joint and rejects the blister automatically with the help of a program in the PLC. The joint should be always on the top side. 

Heating station

A heating station is required to heat the forming foil in the case of PVC-Alu blister formats. Two heating plates are provided i.e. bottom and top sides. For both the plates temp. is kept @ 110 – 125 degrees 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. The top heating plate is operated with the help of a pneumatic cylinder. The bottom heating plate and top heating plate are embedded-type heaters.

Dedicated feeding station 

This station consists of a hopper, linear vibrator, and rotary vibrator. Product material is put into the hopper which is of 50 Lt. capacity. From the hopper the product is 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 a vibrator controller. From the linear vibrator, the product is transferred into the rotary vibrator. The vibration level in the rotary vibrator is controlled by the controller. In the case of PVC-Alu. formats from a rotary vibrator the product is fed into the formed cavities with the help of either a continuous filling shoe or through feeder springs. In the case of the Alu-Alu format, the product is fed into the feeding drum cavities and further, the product is dropped into the formed cavities from the drum.

Forming station

PVC – Alu forming

This station consists of the 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 a Power Pack and the air is blown from the blowing plate ( 6 Bar ). The operation of clamping the plates and blowing the air is done through electronic timings.

Alu – Alu forming – 

This station consists of a bottom plate, top plate, bottom-forming plate, and 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 the 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 the 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 the stereos on the foil.

Print registration system (Optional)

This system is provided to maintain the 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 the roller so that the matter on the lidding foil matches with a particular pocket or with a particular blister.

Non-filled detection system (NFD)

This system is provided to detect any non-filled blisters. 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 pickup station which are connected to the pneumatic line and the vacuum line.

Sealing station

This station consists of the bottom plate, top plate, bottom sealing plate, top sealing plate, heater plate, and pneumatic parts. To match the sealing station with a formed blister, the sealing station can be adjusted with the help of an Allen key. After the station is closed, the hydraulic pressure operates and sealing takes place. The temp. of the top sealing plate is kept from 180- 200 degrees C. depending upon the format size. The hydraulic pressure is the same as the forming station operated by the same Power Pack.

Cooling station

A cooling station is used to cool the sealed web immediately after sealing. This station consists of the top plate, bottom plate, and the change part cooling plate. The web is guided in between the 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 polling station is used to pull the sealed web in continuous motion. The web is pulled by the pulling roller and the thrust roller.  In this, the speed of the pulling roller is synchronized with the main cam.

Embossing cum perforation station

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 that consists of a sliding plate, moving plate, and fixed plate. In the case of only embossing, the embossing unit is a basic part of the machine and the spacers with embossing tools with the holder are a change part. This station is operated by eccentric. The speed synchronization is done with the help of the Servo motor.

Indexing station

This station pushes the sealed web into the punching station with the help of an indexing roller which is a part of the change part. The stroke (equal to blister width) is set with the help of indexing change gears.

Punching station

The punching unit is operated with the help of eccentric and levers. This unit consists of a punch, cutting plate, and support plate which is a change part as per the size of the blister. The speed synchronization is done with the help of the Servo motor.

Pick up station

This system is provided to pick up the blisters after the 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 at 90 degrees. The half-filled blisters are picked up and dropped at 45 degrees into the rejected bin.

Control panel/switch board

MMI  panel and control box are 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 the control panel.

Brief Process Description

General Function

Blister packing machine BQS is a flatbed compressed air forming and flat sealing continuous motion machine suitable for blister packing of tablets/hard gelatin capsules / soft gelatin capsules and cavity depth up to 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 the case of thermoplastic PVC/PVDC thermoplastic as base foil, cavities are formed by compressed air normally 4-6 bar after heating the foil in the heating station at 120 ° C. This web is formed in continuous motion through the forming & sealing station & pulled by a pulling roller. Forming & sealing stations carry out the shuttle movement. The formed web is then sealed in a sealing station with suitable foil.

After sealing, the sealed web is passed through the perforation /embossing station & then to the punching station for cutting the blister. Different types of product infeed systems are used for feeding the product in cavities at higher speeds in continuous motion.

The machine is designed for single or twin-lane operation . Its output depends on the type of product, its layout & arrangement of stripes in one stroke as well as the 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 types of films like Alu-Alu with additional parts. 

The following are the forming techniques used in BQS Compressed air forming:

Flat bed machines are normally designed with compressed air forming.

The thermoplastic film is heated by flat heating plates at 120 –130 ° C & then passed in the forming station to form the cavities. In the 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 the bottom side compared to vacuum forming  & also very low temperature is required to form the cavities as the 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 the 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 hygroscopic products or products affected by light.  In cold forming, forming takes place with the 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. The packing cost is comparatively high.

Forming temperature Air Compressed forming & Plug Assisted forming

Type of Forming – Compressed air forming

Forming Temp Range – 110   –  130

Pressure  4 -6  Bar Pressure

Type of Forming – Plug assist air Forming

Forming Temp Range – 85  –  110

Pressure –4- 6   Bar Pressure

DESIGN QUALIFICATION (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.

TECHNICAL SPECIFICATIONS

Model – BQS

Type- Thermoforming Blister Packing Machine

Weight

Basic machine – 2500 kg approx.

Packing case -3400 kg approx.

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.

Suitable Working Temperature range –5 to 40 Degree C/ Noise Level 70 db (approx.)

Suitable Humidity range for the machine –40 – 70 %

Electrical Supply   Requirement –Supply Voltage: 415 V AC +/- 10% Phase + Earth, Supply Frequency: 50 Hz +/- 2%

Compressed Air Requirement – 30-35 CFM at 7-8 bar near the machine.

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.

Sub assembly Name = PVC Unwinding station

Manufacturer = Pam Pac Machines

PVC Unwinding motor –Make -Technocrat, HP -0.15 HP ,RPM -1400 RPM

Rubber ring –Material -Silicon Rubber

Base foil Joint Detection Sensor – Specification -PNP / 24 V DC

Sensor for Dancing lever –Type – Inductive

Sub assembly Name = Heating station

Heating Plate (Bottom) –Material -Al. Casting (LM 9) ,Treatment -Teflon coating

Heating plate top – Material -Al. Casting (LM 9)

Pneumatic Cylinder (Tendom) –Make -Festo

Sub assembly Name = Forming station,   Manufacturer = Pam Pac Machines

Top Plate –Material – LM 6 ( Alloy ) ,Treatment – Anodizing

Bottom Plate –Material -IS 734 Al. Alloy ,Treatment – Anodizing

Hopper –Material -SS 316 ,Finish -Buffed RA 0.2 ,Capacity -50 Ltrs.

Linear Vibrator –Material -SS 316 ,Finish -Buffed RA 0.2

Sub assembly Name = Sealing station, Manufacturer = Pam Pac Machines

Top Plate  –Material -Al-H 20 T 6 ,Treatment -Anodizing

Bottom plate –Material -Al-H 20 T 6 ,Treatment – Anodizing

Sub assembly Name = Cooling station , Manufacturer = Pam Pac Machines

Bracket –Material LM 16

Top Plate ,Material H9 T6,Treatment GBB

Bottom plate  ,Material H9 T6 ,Treatment GBB

Sub assembly Name = Overprinting station, Manufacturer = Pam Pac Machines

Ink Cartridge –Size -Dia.50 X 245 Lg.,Ink type -DIPL 39 ,Thinner type -DIPL 20

Pressure roller – Material -M. S. ,Treatment -BNP

DETAILS OF UTILITIES

Equipment Name – Blister Packing Machine

Equipment Model – BQS

The following utilities are required

Compressed Air ( Dry ) –Pressure – 7 to 8 Kg / Sq.cm ,Capacity  – 30 to 35 CFM.

Chilled water  –Cooling Capacity -4500 KCAL / hr. ,Temp. – 18 to 20 Degree C ,Flow rate – 15-20 Liters / min.

Elect. Supply –415 V, 50 Hz. ,Average 7 KW ,Peak 14 KW.

Sub assembly Name = Punching and perforation station,  Manufacturer = Pam Pac Machines

Cutting plate (change part)  –Material – HCHCr ,Hardness – 58-60 HRC ,Treatment – Blackodising

Punch (change part) –Material – HCHCr ,Hardness – 58-60 HRC ,Treatment – Blackodising

Change gear (Change part) – Material -EN8 / SAE 8620 ,Hardness -55-60 HRC ,Treatment -Blackodising

Sub assembly Name = Punching and perforation station, Manufacturer = Pam Pac Machines

Moving plate (Change part)  –Material – EN-8 ,Treatment – Blackodising

Sliding plate (Change part) ,Material – M.S. ,Treatment – Blackodising

Support plate (Change part)

Material – H9 T6

Treatment – Anodized

Suction Cup  – Material – Polyurethane

Good bad sorting chute – Material- SS 304

Suction wheel  –Material – Nylon

IDENTIFICATION OF COMPONENTS FOR CALIBRATION

In the Thermoforming Blister Packing Machine model BQS, the following are the components, which need calibration. They shall be calibrated during/ before the installation of the equipment at the site.

The 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 gauges (main pressure)

MATERIAL OF CONSTRUCTION

• Main frame – M. S.
• Cladding covers  – SS 304
• Hopper -S.S 316
• Distributor plate -SS 316
• Linear vibrator -SS 316
• Feeding sector – Al. Anodized
• Good Bad Sorting Chute – SS 304

SAFETY FEATURES AND ALARMS

Safety interlocks have been incorporated 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

Sensor for forming foil

• Foil end
• Foil consumed/broken
• The machine stops at the zero position

Air pressure

• Low air pressure
• Air pressure bellow 5 Bar
• The machine stops at the zero position

Water pressure

• Low water pressure
• No water supply
• The machine stops at the zero position

Machine guard

• Guard open
• The forming/sealing station guard was not closed properly
• The machine stops at the zero position

Vacuum pump

• Vacuum pump off
• Vacuum pump shut off
• The machine stops at the zero position

Low temp.- forming

• Temp. is low
• When the actual temp.is less than 15 degree C.
• The machine stops at the zero position

Low temp.- sealing

• Temp. is low
• When the actual temp.is less than 20 degree C.
• Machine stops at zero position

High temp.- forming

• Temp. is high
• When the actual temp.is more than 20 degree C.
• The machine stops at the zero position

High temp.- sealing

• Temp. is high
• When the actual temp. is more than 20 degree C.
• Machine stops at zero position

Eye mark

• Eye mark missing
• Continues 5 eye mark not sensed by scanner
• The machine stops at the zero position

Buzzer

• Buzzer operates
• Continuously product missing
• Buzzer operates

Sealing thermocouple

• Thermocouple open
• The thermocouple is open for more than 3 min.
• Machine stops at zero position

Sensor for lidding foil

• Foil end
• Foil consumed/broken when clutch is ON
• The machine stops at the zero position

Emergency off

• Emergency off
• Pressed Emergency push button
• Machine stops instantly

Water pressure

• No heating, No water
• When the water flow is off
• The machine stops at the zero position

Overload

• Machine overload
• When there is mechanical load on the machine
• Machine stops at zero position

MCB

• MCB Trip
• Any MCB trip
• The machine stops at the zero position

Air blowing – sealing

Air blows while machine is in stopped condition

Air blowing – Punching

Air blows while machine is in running condition

Indexing

• Indexing overload
• The web slipped during indexing and sensed the web
• The 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 

Operational Qualification for Pass Box