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BY PHARMACEUTICAL GUIDANACE ON JUNE 28, 2016 OTHER, QUALIFICATION, VALIDATION & QUALIFICATION
TABLE OF CONTENT
Objective
Scope
Responsibility
Machine description
Technical specification
Technical specifications and make of sub-components/ bought out items.
Details of Utilities FACEBOOK
Identification of components for calibration
Material of construction of all components
Safety features and alarms
FAT procedure
Change control procedure
Qualification Document report approval Like Page Share
Appendix
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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
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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. Pharmaceutical Guidance
To confirm the safe delivery of the equipment to the user site.
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To ensure that no un-authorized and / or unrecorded design modifications shall take
92 seguidores
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-Pacs 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
TECHNICAL SPECIFICATIONS
Description Specification
1. Model BQS
3. Weight
12. Electrical Supply Supply Voltage: 415 V AC +/- 10% Phase + Earth
Requirement Supply Frequency: 50 Hz +/- 2%
Power Consumption: Average: 7 KW
Peak: 14 KW.
13. Compressed Air 30-35 CFM at 7-8 bar near the machine.
Requirement
Voltage 415 V AC
Quantity 1 No.
Size 50 X 5
Quantity 2 Nos.
Specification PNP / 24 V DC
Quantity 1 No.
Quantity 2 No.
Quantity 1No.
Heating plate top Material Al. Casting (LM 9)
Watt W
Quantity 1No.
Quantity 1 No.
Size 50 x 25
Quantity 1 No.
Treatment Anodizing
Quantity 1 No.
Treatment Anodizing
Quantity 1 No.
Motor HP 5 HP
Phase 3 Ph.
Voltage 415 V AC
Quantity 1 No.
Quantity 1 No.
Quantity 1 No.
Capacity 50 Ltrs.
Quantity 1 No.
Quantity 1 No.
Quantity 1 No.
Quantity 1 No.
Quantity 1 No.
Quantity 1 No.
Treatment Blackodising
Quantity 04 No.
Voltage 415 V AC
Phase 3 Ph.
Quantity 1 No.
Treatment Anodizing
Quantity 1 No.
Treatment Anodizing
Quantity 1 No.
Motor HP 5 HP
Phase 3 Ph.
Voltage 415 V AC
Quantity 1 No.
Quantity 1 No.
Treatment GBB
Quantity 1 No.
Size Dia. 80 x 15
Quantity 1 No.
Bracket Material LM 16
Treatment GBB
Quantity 1 No.
Treatment GBB
Quantity 1.No.
Treatment GBB
Quantity 1 No.
Quantity 1 No.
Pressure Material M. S.
roller Treatment BNP
Quantity 1 No.
Treatment Blackodizing
Quantity 1 No.
Material HC HCr
Pulling disc Hardness 45 50 HRC
rear
Treatment Blackodizing
Quantity 1 No.
Ratio 1:30
Quantity 1 No.
Torque 5.3 Nm
Quantity 1 No.
Specification 6006 ZZ
Quantity 2 No.
Ratio 7.5:1
Quantity 1 No.
Torque 7.5 Nm
Quantity 1 No.
Treatment Blackodising
Quantity 1 No.
Treatment Blackodising
Treatment Blackodising
Quantity 1 No.
Quantity 1 No.
Treatment Blackodising
Quantity 1 No.
Treatment Anodized
Quantity 2 No.
Pressure 25 of Hg.
Quantity 1 No.
HP 2 HP
Phase 3 Ph.
Quantity 1 No.
Material Polyurethane
Quantity 4 No.
Quantity 2 Nos.
Finish Matt
Quantity 4 Nos.
6.12 Sub assembly Name =Controls
Manufacturer = Pam Pac Machines
Voltage 24 V DC
Amp. 10 A
Quantity 1 No.
Voltage 415 V AC
Phase 1 Ph.
Quantity 1 No.
Model TL 10
Quantity 1 No.
Type C 221
Quantity 2 No.
Quantity 1 No.
Quantity 2 No.
DETAILS OF UTILITIES
1. Main frame M. S.
2 Air pressure Low air pressure Air pressure bellow 5 Machine stops at zero
Bar position
5 Vacuum pump Vacuum pump off Vacuum pump shut off Machine stops at zero
position
6 Low temp.- Temp. is low When the actual Machine stops at zero
forming temp.is less than 15 position
degree C.
7 Low temp.- Temp. is low When the actual Machine stops at zero
sealing temp.is less than 20 position
degree C.
8 High temp.- Temp. is high When the actual Machine stops at zero
forming temp.is more than 20 position
degree C.
9 High temp.- Temp. is high When the actual temp. Machine stops at zero
sealing is more than 20 degree position
C.
10 Eye mark Eye mark missing Continues 5 eye mark Machine stops at zero
(Optional ) not sensed by scanner position
13 Sensor for lidding Foil end Foil consumed / Machine stops at zero
foil broken when clutch is position
ON
15 Water pressure No heating, No When water flow is off Machine stops at zero
water 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
AC Alternate Current.
MS Mild steel
SS Stainless Steel
DQ Design Qualification
Hz Heartz.
Kg Kilogram.
No. Number
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