Standard Operating Procedure of Blister Packing Machine Operational SOP in Pharmaceuticals is describe in this post.
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1 PURPOSE
1.1 It is established to provide a system of operation for Blister Packing Machine DPB 250
2 SCOPE
2.1 It is applicable to Production Department of Pharmaceuticals.
3 RESPONSIBILITIES & AUTHORITIES
3.1 Supervisor
3.2 Machine Operator
4 REFERENCE
4.1 Quality Management Manual
5 DEFINITIONS
5.1 List of GMP Techniques
6 PROCEDURE
6.1 PRE-OPERATION:
6.1.1 Make sure that “Line Clearance” from Quality assurance department has been taken.
6.1.2 Make sure that valve of compressed air has been opened.
6.1.3 Check oil and water filters, drain oil and water filter if required.
6.1.4 Check the oil level in lubrication trays under the main shaft of blister machine.
6.1.5 Check the BMR and assemble the respective forming plate in case of PVC and forming Dies Unit in case of Alu/Alu.
6.1.6 Then assemble the sealing plate.
6.1.7 Assemble and align the Batch number digits in slot of batch plate.
6.1.8 Assemble the cutter of the respective product.
6.2 OPERATIONS:
6.2.1 Attach the plug in wall socket to power “ON” the machine
6.2.2 Turn “ON” the sealing heater in case of Alu/Alu and in case of Alu/PVC turn “ON” the forming heater.
6.2.3 Adjust the temperature of heater for forming plate between 125ºC-130ºC.
6.2.4 Adjust the sealing heater temperature in case of PVC between 135ºC -140ºC
6.2.5 Adjust the sealing heater temperature in case of Alu/Alu foil between 165ºC-170ºC.
6.2.6 After adjusting the respective temperature of heaters wait to attain the set temperature on control panel to ensure proper sealing during blistering.
6.2.7 Turn on the chiller and note the temperature of chilled water on display weather it is working properly or not.
6.2.8 In case of any problem call to engineering department
6.2.9 Put the PVC /or Alu/Alu Rolls in place and pass through the required path (e.g. forming plate, feeding channel, sealing plate and finally through the cutter).
6.2.10 Put in place the respected printed aluminum foil.
6.2.11 Adjust the bubbles, with respect to the sealing plate batch number plate and cutter accordingly.
6.2.12 Run the machine to get first 20-50 empty blisters.
6.2.13 Inspect them critically and check batch number, manufacturing date and expiry date which should be according to the BMR or respective product
6.2.14 Check the embossing digits, alignment of bubbles and alignment of printing foil, as well as matter.
6.2.15 Send 20-30 empty checked blisters to QC department for “blister leakage test”
6.2.16 After confirmation of leakage test from QC department run the machine and use tablet spreader to get tablets into the blister pockets.
6.2.17 Run the machine smoothly
6.2.18 The blister coming out of machine should be inspected critically and check their sealing, batch number, alignment and printed matter as well.
6.2.19 The rejected blister should be collected separately and de blister them and then finally re blister them.
6.2.20 If these preliminary checks are satisfactory, the blistering
6.2.21 At regular intervals of time (specific for the product being packed) the leakage test should be performed.
6.2.22 Blister packing of tablets should be carried out in an environmental area. (Temperature of 22 to 25°C) and relative humidity < 50%.
6.2.23 At the end of the working shift, the product left in hopper or tablet spreading unit should be removed. Any blister lying on the packing line should also be removed.
6.3 PRECAUTIONS
6.3.1 Never use metal rods to adjust sealing plate. This can damage the equipment.
6.3.2 Check that sufficient chilled water is supplied to the forming die for cooling blisters.
6.3.3 Clean the sealing plate during production with wire brush as and when required.
6.3.4 Do not touch the moving parts during operation.
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