sop for operation and cleaning of blister packing machine

Purpose
1.1 To lay down a procedure for Operation and cleaning of Blister Packing Machine.
2.0 Scope
2.1 This SOP is applicable for Operation and cleaning of Blister Packing Machine in ABC Pvt. Ltd.
3.0 Responsibility
3.1 Production Chemist To follow the Procedure & Execute the activity.
Trained Machine Operator To execute the activity as per SOP.

4.0 Accountability
4.1 Production Head is accountable for compliance of this SOP.
5.0 Procedure
5.1 Pre-Start Up
5.1.1 Visually inspect the blister packing machine& the area for cleanliness.
5.1.2 Ensure that the environmental condition complies as specified in the BPR.
5.1.3 Update the status label of the Area.
5.1.4 Get the line clearance from the QA Officer.
5.2 Start Up
5.2.1 Switch ‘ON’ the main supply.
5.2.2 Switch ‘ON’ the Machine.
5.2.3 Set the Forming & Sealing Heater as Auto or Manual mode.
5.2.4 Set the Forming Heater temperature by forming temperature controller as specified in BPR.
5.2.5 Set the Sealing Heater temperature by sealing temperature controller as specified in BPR.
5.2.6 Switch ‘ON’ chilled water unit.
5.2.7 Switch ‘ON’ Vacuum pump.
5.2.8 Switch ‘ON’ counter.
5.2.9 Switch ‘ON’ vibrator controller and set the vibrator controller.
5.2.10 Switch ‘ON’ feed motor.
5.2.11 Fill the ink in the inkpot up to the required level and fix it back to the BCP unit.
5.2.12 Set the correct stereos on the stereo drum & adjust it accordingly.
5.2.13 Fix back the stereo drum to its original position after fixing the stereo on it.
5.2.14 Load the PVC roll to the heating station and adjust the alignment through the forming

station up to the sealing station.
5.2.15 Load the printed aluminum foil and adjust its alignment from the roll up to the

sealing station through the BCP unit.
5.2.16 Check the proper cutting of packs after passing though the punching station.
5.2.17 All guard of the machine closed tight.
5.2.18 Take out the print of stereo on the aluminum foil.
5.2.19 Check the Aluminum foil for correct batch details as specified in the BPR.
5.2.20 Ensure that printed Aluminum foil must be counter checked by production and In-process QA Officer.
5.2.21 Set the machine speed by using speed knob.
5.3 Operation
5.3.1 Load the tablets/capsule in to the hopper of blister pack machine.
5.3.2 Ensure that the discharge of the tablets / capsules from hopper to chute / feeding box is proper.
5.3.3 the activity.
5.3.4 Cleaning Start the machine in inching mode and check the formation of cavity.
5.3.5 Critically examine the first 10-15 blisters for defect such as:-
• Miss- printing on aluminum foil.
• Improper cutting of blister.
• Improper sealing is to be check by leak test apparatus.
• Other defects such as scratch on blister.
5.3.6 After ensuring that the blisters are OK, starts the machine.
5.4 Unloading & Shut Down
5.4.1 If machine is stopped due to breakdown, following sequence of operation must be followed:
5.4.1.1 Stop the Vibrator first.
5.4.1.2 Push the red emergency button to stop the machine
5.4.1.3 Remove the chute from its alignments.
5.4.1.4 Switch “OFF” the heat – sealing roller.
5.4.1.5 Any tablet/capsule which comes in contact with the roller, is removed and discarded.
5.4.2 Remove the Aluminum foil and PVC roll from the mounting shaft.
5.4.3 Remove the Tablets/Capsules from the Hopper, bowl and Chute and ensure that

there are no tablets/capsules remains in the machine.
5.4.4 Switch “OFF” the main power supply.
5.4.5 Update the status board.
5.4.6 Record the activity in log book.
5.5 Again, take the line clearance from QA before starting
5.5.1 Type A: At the time of Product-to-Product changeover
5.5.1.1 Switch “OFF” Main power supply.
5.5.1.2 Update the status label as “UNDER CLEANING”.
5.5.1.3 Removed out the inkpot from the BCP unit and empty out the ink from inkpot.
5.5.1.4 Clean he inkpot by using thinner & fix it back to its proper position.
5.5.1.5 Remove the stereo drum from the BCP unit.
5.5.1.6 Remove & destroy the used stereos as per SOP.
5.5.1.7 De dust the machine body by using vacuum cleaner in case of uncoated tablet & In case

of Coated Tablet clean the machine body dry clean cloth.
5.5.1.8 Take out the dismantle parts like hopper, bowl plate and Feeder to the washing area.
5.5.1.9 Clean the dismantle parts by using Raw water and then wash with purified Water.
5.5.1.10 Assemble the cleaned dismantled parts.
5.5.1.11 Change the change parts to other product as required.
5.5.1.12 Record the cleaning activity in the log book.
5.5.2 Type B: At the time of Batch-to-Batch Changeover
5.5.2.1 Switch “OFF” the machine and main power supply.
5.5.2.2 Update the status board as “UNDER CLEANING”.
5.5.2.3 Remove the stereos drum from the BCP unit.
5.5.2.4 Destroy the used stereos as per SOP.
5.5.2.5 De dust the machine body by using vacuum cleaner in case of uncoated tablet & In case

of Coated Tablet/capsule clean the machine body dry clean cloth.
5.5.2.6 Clean the hopper, bowl plate, and feeder with the dry lint free cloth.
5.5.2.7 Clean the sealing plate with brass brush & cleaner fluid.
5.5.2.8 Clean the feeding box visually inspects all the brushes.
5.5.2.9 Ensure that there is no tablet/capsule of previous batch is remaining inside and outside the machine.
5.5.2.10 Record the cleaning activity in log book.
5.6 Drying Procedure
5.6.1 After cleaning of Blister packing machine, mop the machine from inner and outer side.
5.6.2 Ensure the complete dryness of machine and its accessories.
5.6.3 Affix cleaned status label on machine after ensuring complete drying.
5.6.4 Always kept the machine well closed while not in use.
5.7 Training shall be provided to the concerned person.

6.0 References:
In-house
7.0 Attachment
Nil

8.0 Distribution:
8.1 Distribution of the controlled copy of the SOP shall be made by concerned departments.
8.2 Additional copies may be issued for specific purpose.

9.0 Abbreviations:
SOP : Standard Operating Procedure
Pvt. : Private
Ltd. : Limited
QA. : Quality Assurance
BPR : Batch Packing Record
BCP : Batch Coding Printing
PVC : Polyvinyl Chloride

Revision No.	Supersedes	Effective Date	Details of Reason
01	Nil		New SOP

sop for operation and cleaning of blister packing machine

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