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.
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
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 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 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 – 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
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:
- Temperature controller for sealing station
- Temperature controller for forming station
- Vibrator controller for linear vibrator
- Vibrator controller for Rotary vibrator
- Temperature controller (Heating plate top)
- Temperature controller (Heating plate bottom)
- Temperature sensor (Inlet water temp.)
- Vacuum Gauge
- 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
-Machine stops at zero position
Air pressure
-Low air pressure
-Air pressure bellow 5 Bar
-Machine stops at zero position
Water pressure
-Low water pressure
-No water supply
-Machine stops at zero position
Machine guard
-Guard open
-Forming/sealing station guard not closed properly
-Machine stops at zero position
Vacuum pump
-Vacuum pump off
-Vacuum pump shut off
-Machine stops at zero position
Low temp.- forming
-Temp. is low
-When the actual temp.is less than 15 degree C.
-Machine stops at 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.
-Machine stops at 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
-Machine stops at zero position
Buzzer
-Buzzer operates
-Continuously product missing
-Buzzer operates
Sealing thermocouple
-Thermocouple open
-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
-Machine stops at zero position
Emergency off
-Emergency off
-Pressed Emergency push button
-Machine stops instantly
Water pressure
-No heating, No water
-When water flow is off
-Machine stops at zero position
Overload
-Machine overload
-When there is mechanical load on the machine
-Machine stops at zero position
MCB
-MCB Trip
-Any MCB trip
-Machine stops at 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
-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:
- Functioning of Machine operating panel with MMI
- Interlocks and safety features provided.
- Details of major components fitted on the machine
- Carry out product run and fill test criteria with product.
- Check deficiency and corrective action taken report.
- 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
