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. To describe the Installation Qualification procedure to be used during qualification of Blister Packing Machine (BQS), its accessories and to. To describe the Operational Qualification procedure to be used during qualification of Blister Packing Machine (BQS), its accessories and to.
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To design, engineer, and maxhine the Blister Packing Machine Model: 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.
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.
Foil is clamped by blitser leading screw. The center distance with respect to base plate face is 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.
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 macine on boister top side. Heating station is required to heat the forming foil in case of PVC-Alu blister formats.
Two heating plates are provided i. Bbqs both the plates temp. To avoid the sticking of forming foil with heating plates, mmachine 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.
OQ of Blister Packing Machine (BQS)
This station consist of hopper ,linear vibrator and rotary vibrator. Product material is put into packagging hopper which is of 50 Lt. 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.
DQ of Blister Packing Machine (BQS) – Pharmaceutical Guidance
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. 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 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.
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. This station is used to give batch code printing provision on the blister. The stereos are fixed on the stereo roller and foil is passed through the stereo roller machlne pressure roller to get the impressions of stereos on the foil. Basically this system is provided to maintain position of the particular macnine matter on the Al.
The eye mark on the Al. 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 packagingg the suckers provided in the pick up station bqqs are connected to the pneumatic line and the vacuum line. Packaglng station consist of bottom plate, top plate, bottom glister 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 hydraulic pressure is same like forming station as operated by same Power Pack. 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. 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. This station is provided to do the embossing for providing batch no. The perforation cum embossing is a change part which consist of lbister 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. 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 machlne of indexing change gears.
Bqs (Blistering Quickly Through Servo)
Punching unit is operated with the help of eccentric and levers. 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.
IQ of Blister Packing Machine (BQS) – Pharmaceutical Guidance
Formed web is then sealed in sealing station with suitable foil. 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. 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. 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. 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.
Packing cost is comparatively high. Forming area x mm. Draw of Length mm. Roll Diameter Forming Film mm x mm width. Roll Diameter Lidding Foil mm x mm width.
Unwinding motor Make Technocraft HP 0. Make Bonfiglioli Ratio 1: Make Technocraft Ratio 7. Change part Part No. Change part Material M. Treatment Blackodising Quantity 1 No. Material SS Quantity 1 No. Output to Volts Quantity 1 No.
Following utilities are required Sno. Item Specification Remarks 1. Supply V, 50 Hz. Cladding covers SS 4. Distributor plate SS 6.
Linear vibrator SS 7. Machine stops at zero position 7 Low temp. Machine stops at zero position 8 High temp. Machine stops at zero position 9 High temp. 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.
After the completion of erection work of the machine, client shall packagihg informed to perform the factory acceptance test FAT.