SOP for Operation & Cleaning of Blister Packing Machine

OBJECTIVE

To lay down a procedure for the operation and cleaning of the Blister Packing Machine.

SCOPE

This procedure shall be applicable to the operation & cleaning of the blister sealing machine, and the installed packing area of PharmaInfo Ltd.

RESPONSIBILITY

Production –Operators / Chemist / Officer

IPQA Chemist / Officer

ACCOUNTABILITY

Head - Production

PROCEDURE

Pre-Start up

When the same batch of the same product is to be continued

• Visually inspect the machine and room for cleanliness.
• Ensure that the previous run was of the same batch number of the same product.
• Ensure that all the tablet containers lying in the room are of the same product and of the same batch which is to be continued.
• Put the “Status label” on the machine.

When a new batch of the same product is to be taken on the machine

• Visually inspect the machine and the room for cleanliness. Ensure that there are no remnants of the previous batch. Inform the Production Executive / Officer to inspect the machine and room for cleanliness. Inform QA Chemist / Officer to approve and certify the equipment & room for cleanliness.
• Check the tablets (which are to be packed) in the tablet store for batch identity and Approved Quality Control stickers on each container and bring them into the blister packing room.
• Bring the PVC and printed aluminum foil from the packaging material entry airlock to the Blister packing room.
• Check that the printing unit is ready along with the stereos of the particular product and batch details.
• Load and adjust the PVC film and printed aluminum foil rolls in the specified position.
• Adjust the alignment of PVC foil and printed aluminum foil.

When a different product is to be taken on the machine

• Visually inspect the machine and the room for cleanliness. Ensure that there are no remnants of the previous batch. Inform the Production Executive/ Officer to inspect the machine & room for cleanliness. Inform QA Chemist / Officer to approve & certify on the “CLEANED” equipment label.
• Put the “STATUS LABEL” on the machine.
• Check that the machine is ready for the blister packing of a particular product and pack.
• Check the tablets (which are to be packed) in the tablet store for batch identity on each container and bring them into the blister packing room.
• Bring the PVC and printed aluminum foil from the packaging material entry airlock to the Blister packing room.
• Check that the printing unit is ready along with the stereos of the particular product and batch details.
• Load and adjust the PVC film and printed aluminium foil rolls on the specified position.
• Adjust the alignment of PVC foil and printed aluminium foil.
• Check the temperature and relative humidity of the Blister packing room. Record the same in the BPR. If it is within the specification as per the BPR, continue the operation. If conditions do not meet the specifications inform the Production Chemist / Officer. Do not proceed further till the required conditions are obtained.
• Check the cleanliness of the packing line and its surroundings.

Startup

• Put the “STATUS LABEL” on the equipment.
• Switch 'ON' the main electric supply of the machine, open the compressed air valve, and switch on the chiller.
• Select the Sealing and Forming heater at the ON position in PLC
• Check the air pressure in the main pressure gauge. It should not be less than 6.0 kg/cm2.
• Switch 'ON' the top platen heater, bottom platen heater, and sealing roller, and set the temperature and air pressure as mentioned below.

HEATERS                    TEMPERATURE

Sealing Heater           180°C

Forming Heater          150°C

• Pass the PVC and Blister foil from the specific position to get it sealed.
• Keep the feeding switch (located near the tablet feeding chute) at 'OFF'.
• Switch 'ON' the vacuum pump.
• Fill the hopper with tablets manually.
• Wet the ink cartridge of the printing unit with an ink solution.

Operation

• Keep the 'INFEED' switch on manual mode.
• Set rotary vibrator frequency.
• Check and set the position of the sensor to maintain the level of tablets in the distributor plate.
• Turn the 'INFEED' switch to 'Auto mode'.
• Push the 'MACHINE ON' press button.
• Slow down the machine's speed.
• Adjust the tension of the foil to remove mismatching.
• Set the pressure of the ink cartridge and printing roller so that each and every impression of the stereo should be clear.
• Push the 'MACHINE OFF' press button.
• Take a piece of printed blister foil having at least 5x2 = 10 prints on it and get it approved by the Production Chemist / Officer and IPQA Chemist / Officer.
• Push the 'Machine On' press button.
• Push the 'Machine Off' press button after 20 strokes approx.
• Pass the sealed web through the perforation guide roller, indexing roller, and punching tool and observe for satisfactory cutting and adjust if necessary.
• Push the ‘Machine On’ press button.
• Check the sealing, cutting, and printing of blisters coming out.
• Switch 'ON' the feeding.
• Check the blisters for various quality parameters as specified in the packaging inspection record.
• Perform the leak test.

ALSO READ: SOP for Cleaning and Operation of Vial Washing Machine

Shutdown

• Turn the knob of the chiller to 'OFF'.
• Push the Red-colored press button (located on the control panel) to 'OFF' the main electric supply.
• Turn the red regulator OFF.
• Close the valves of compressed air.

Cleaning Procedure

• Take out the tablets from the hopper and distributor plate and put them in HDPE containers lined with double poly bags same batch and close the container properly.
• Ensure that no tablets are left in the feed track and feeding channels.
• Put all the rejected packs into a container and put a status label on it.
• Clean the machine parts using a duster.
• Clean the upper sealing plate using a cleaning solution (thinner) and a brush.
• Clean the surrounding area of the machine.
• Enter the cleaning time in the equipment log sheet, sign it, and get it counter-signed by the Production Chemist/ Officer.

Cleaning Steps

• Hopper, Vibrator plate, Distributor plate, Dust collecting chute, Feeding channels cleaned with compressed air and duster.
• Film splicing table, Heating plates, Forming plates, Guide plate, Dedusting brush, Perforation unit, Indexing roller and Punching tool cleaned with compressed air.
• Sealing plate using cleaning solution (thinner) and brass brush.
• The machine body, Acrylic covers, Control panel machine base, and other contact parts were cleaned with compressed air and a duster.
• Clean the machine parts with a duster.
• Clean the upper sealing plate using a cleaning solution (thinner) and a brush.
• Clean the hopper and distributor plate with a duster.
• Clean the outer portion of the machine by using a duster.
• Enter cleaning time in the equipment log sheet, sign it, and get it countersigned by the Production Chemist / Officer.
• Put the “CLEANED” label on the machine approved by the Production Chemist/ Officer and IPQA Chemist/ Officer.

Cleaning during a changeover of product with different actives, color, descending potency Type 'B'

• Switch 'OFF' the machine.
• Clean the machine parts using a duster.
• Remove all the remnants of the previous batch from the surrounding area and machine.
• Dismantle the following parts of the machine:

1. Hopper
2. Vibrator plate
3. Distributor plate
4. Dust collecting chute
5. Feeding channels
6. Feeding shoe assembly
7. Dedusting brush
8. Sealing plates

• Clean the sealing plate using a cleaning solution (thinner).
• Take out the hopper, distribution plate, and channel, carry it to the washing area and clean it by using potable water. Finally, rinse with purified water.
• Clean the body of the machine using a duster dipped in purified water and wipe it with a dry duster.
• Clean the return air filters.
• Enter cleaning time in the Machine log.
• Inform the IPQA Chemist / Officer to take rinse water sample of the hopper, distribution plate, and channel.
• Dry the hopper, distribution plate, and channel under infra-red air and take them to the blister packing room and assemble these on the blister packing machine after getting approval by the IPQA Chemist / Officer.
• Put the 'Cleaned' label and get clearance from the QA Dept.

Precaution

• Ensure that no blisters with tablets Sealing station during the regular breaks.
• Ensure that the room is cleaned before the clean and dry parts are brought in.
• Ensure that all parts and the machine are dry before assembling.
• Allow both potable water and purified water to run for one minute before using it for cleaning.

REFERENCE

In house

ANNEXURE

Nil

ABBREVIATION

SOP: Standard Operating Procedure

No.: Number

SS: Stainless Steel

PP: Polypropylene

PVC: Poly Vinyl Chloride

PLC: Programmable Logical Control

BPR: Batch Production Record

IPQA: In Process Quality Assurance

QA: Quality Assurance

kg/cm2: Kilogram Per Centimeter square

REVISION HISTORY

Nil

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