MAN-075 Example of a Tablet Packing Machine -Construction, Operation and Cleaning

1. Blister Machine Setup

            In order to demonstrate a production line we choose to show you a tablet packing operation in this chapter. The pictures we have used for this purpose does not constitute any existing line under operation now. The pictures were taken only for training purpose and the line which it belonged to was decommissioned long time ago.

Part A

Part A of a typical tablet packing machine is made up of the following sections sequentially designed from 1 to 6.

Base foil drive:Generally PVC/PVDC foils are used as the base foil. When a new PVC film roll is introduced in a machine the foil drive holds the roll and helps the film to pass through the machine by revolving clockwise.

Accumulator: Accumulator can accumulate some extra films at the time of new roll change without stopping the machine. Because of the accumulator new PVC roll can be introduced without stopping the machine.

Base foil holding rollers: These set of rollers rotates clockwise and helps the film to pass through the preheating and forming station keeping the film with consistent tension and alignment with forming station.

Pre-heating station: The film is being softened here with a set temperature and makes the film ready to form desired blister pockets in a forming station.

Forming station: This station is equipped with two forming tools with desired molding size. The station is heated with a minimum and maximum temperature range. Heated sides press against each other to produce a web of blister pockets.

Blister draw off device: Helps to draw the blisters downward as the blister is formed.

Part B

Part B of the packing line is a continuation of part A. Following are the descriptions of some points of part B:

Base foil splicing sensor: This sensor detects any splice (joining with sticky tape) in the PVC film and rejects the splicing parts.

Figure 1

Intermediate Bulk Container (IBC): This IBC bins are filled with bulk tablets dispensed from the dispensary.

IBC labels: IBC labels are attached with the bin in a plastic sleeve at the time of dispense in order to identify the correct container and the contents readily.

IBC lifting hands: Holds the IBC bin in a lifted position.

11 & 12. Hopper & Vibrator tray: IBCs are connected to a hopper to allow a controlled flow of tablets into a vibrator tray. Vibrator try vibrates gently to help the vacuum dust collector to suck the loose particles away.

Pin hole detector: These two set of sensors can detect any hole on the blister web with a diameter of 100 micron or more and rejects those blisters.

Figure 2

Part C

Part C of the packing line is a continuation of part B. Following are the descriptions of some sections of part C:

14 & 15. Vibrator feeder plastic hose: This plastic hose collects and transfers the tablets from the vibrator tray to a tablet feeder. 15 is the dust collector connected to a vacuum.

Tablet feeder: This automatic tablet feeder is assembled with different parts like screens which separate the unwanted tablet fragments from the good ones and feeder tubes which helps the individual tablets to sit on the blister pockets.

Wiper pad: Clean wiper pads are used to wipe the blister surface so that tablets can sit properly on the formed blister pockets.

Protruding product flap: This is to ensure tablet does not stand on the blister surface or jumped off the bed.

Vision camera system: This camera system takes pictures from the top of the blisters before being sealed with a foil and displays on a screen if there is any rouge tablet. It can detect any change of tablet colour, size, shape, tablet fragments and unwanted particles based on the programming set at the beginning of the batch run. For any non conformance the machine will stop and inspection needed. If a blister strip such as the one in the figure below will pass under the camera, the machine will reject the blister.

Figure 3

Part D

Part D of the packing line is a continuation of part C. Following are the descriptions of some parts in this area:

Lid foil drive: Generally pre specified aluminum foils are used as the lid foil. When a new lid foil roll is introduced in a machine the foil drive holds the roll and helps the film to pass through the machine by revolving clockwise.

Lid foil holding roller: These set of rollers rotates and helps the film to pass through the splicing sensor, registration mark sensor and tracking control device before the foil passes through the sealing station.

Lid foil splicing sensor: This sensor detects any splice (joining with sticky tape) in the lid foil roll and rejects the splicing parts.

Registration mark sensor: Registration mark is like a barcode which identifies which is unique for each foil. The trained sensor can detect if any unknown foil will pass through it and rejects that foil.

Foil tracking control device: A set of two sensors controlling the tracking of lid foil alignment before it will mixes with the PVC film with right alignment.

Lid foil stretch and draw off device: This device helps to maintain the lid foil with appropriate tension and draws off the foil downward before passing through the sealing station

Sealing station: This station is heated with a set temperature and seals the blister foil and printed lid foil with correct alignment.

Part E

Cooling station: Cooling station is just adjacent to the sealing point and used to cool down the heated blisters to seal properly.

Part F

Part F is the continuation of part E of the tablet packing line.

Blister coding station: Here the sealed blisters are coded with batch number and expiry date for the batch on one side of the blister by a pre-set coding block .

Blister indexing roll: This circular index roll has perforated surface exactly the same size as those of the blister pockets. This roll helps the blister web to index properly into right alignment before being punched as a separate blister strip.

Punching station: A sharp punching knife cut down the continuous blister web into separate blister strips.

Blister transfer arms: These arms pick the strips by using controlled vacuum, rotating anti clockwise as shown in the picture and put the blisters separately onto a blister conveyor by releasing the vacuum.

Part G

Carton magazine: Holds flat cartons and release one carton at a time.

Vacuum transfer arms: These arms pick the cartons by using controlled vacuum, rotating anti clockwise as shown in the picture and place the cartons separately onto a carton conveyor by releasing the vacuum.

Carton counting sensor: This sensor counts the number of carton passing onto the conveyor.

Blister inserter arms: When blister/s are stacked in one place, those are transferred to an open carton by the blister inserter arms.

Barcode sensor: This sensor identifies the carton barcode, which is unique for each carton. The trained sensor can detect if any unknown carton will pass through it and rejects that carton.

Carton coding block: In this station cartons are coded on the cover by variable data with a coding block disc.

Print presence sensor: This previously trained sensor identifies the presence of correct variable data on the carton. If a carton with incorrect data or no data at all will pass through, it will rejects the carton.

Part H

Checkweigher: This automatic device checks the weight of each carton passing through its weighing scale. This device is programmed with a certain weight range (depending on the product to be packed) which can spontaneously detect any carton with under or over weight. There is a sensor to count the number of carton passing the scale at any time. A pneumatic arm rejects carton with faulty weight or if there are more than one carton pass the scale at the same time.

 Part I

2. Machine Operation

3.1. Starting the Blister Machine

i.    Turn ON Main switch located at the back of the machine.

ii.    Check Heating (5) is turned ON.

iii.    Wait until machine has reached the pre-set temperature.  This can be verified by going into the Heating menu of the touch screen (7) and comparing the Actual temperature to the Pre-set temperature.

iv.    While waiting for the stations to heat up, check the PVC (3), foil (10) and waste grid (17) is threaded correctly.

v.    Check the correct recipe is loaded into the operator control panel (7).  Also check the correct program is loaded into the Scanware (8) and the correct draw length has been entered.

vi.    Turn the machine ON.  If machine does not start, go to the Disturbance menu to Acknowledge the fault, then rectify the fault before trying to restart.

3. Handling of Product

4.1.       Bulk Tablets

Refer to the Planning Schedule, MI sheet and Transfer Order to identify the correct manufacturer’s bulk that will be used in the process.

4.2.       Loading of tablets into the machine

PLEASE NOTE: Gloves must be worn when handling tablets.

Tablets will be loaded by a trained operator into the Hopper from IBC.

4. Missing and Broken Tablet test

The purpose of this test is to challenge the Vision system to ensure it is working correctly. The Vision system must be challenged at the start of every BPN, start-of-day and every time the Vision system is re-learnt.

4.1.         Test Method

4.1.1.     Start with the Missing Tablet test.  To validate that the entire region of the blister is being scanned by the vision system, four consecutive blisters in row are tested.  A pattern is used to give the camera an opportunity to test the different location of faults.

4.1.2.     Start at the leading edge of the first blister and as you move across to the next blister remove the tablet one position along the row (see Figure 1).

4.1.3.     On the next set of four consecutive blisters, repeat the pattern in reverse, (see Figure 2).  Place into the vacant holes, a tablet that has been cut to represent a broken tablet.

Figure: Vision Camera System Challenge

4.2.1.     The Repeat fault needs to be turned OFF for the Challenge.  Start the machine.  Verify that the Vision system is locating the faults on the blisters by watching the monitor, and ensuring that the blisters are ejected at the Eject station.  If the test fails, contact a line Fitter.

5. The Start of a Batch Production

5.1.         NOTE: The Line Opening checklist and batch documentation must be completed before production starts.

5.2.         After completing the Vision system challenge, run the machine to collect enough blisters to fill the Cartonner spiral and to perform the Checkweigher challenge.  Inspect these blisters for correct form, registration, correct and legible BPN details and that there are no broken or missing tablets.

5.3.         Perform the Leak test as per SOP MAN-095.

5.4.         When the blisters have been inspected and they conform to the set standard, load them into the Cartonner.

6. The Start-of-Day

When a process continues for more than a day’s run, the operators must repeat the same procedures as for start of a BPN.  Therefore, the operator must preform a:

a. Vision system challenge

b. Start-up Leak test

c. Barcode challenge (SOP MAN-065)

d. Checkweigher challenge. (SOP MAN-110)

7. Process Monitoring

7.1.         In-process tests are carried out as specified SOP MAN-115.

7.2.         During machine operation, blisters are to be removed every five minutes to check for form, registration and legible coding.

7.3.         Maintain the level of cartons and leaflets in there respective magazines.

7.4.         Check the Wiper brush, (which is located after the Brush Box) is removing tablets that are not positioned in the pockets correctly.

7.5.         When changing foil and PVC, monitor the join as it travels through the machine to ensure it is rejected.

8. Production Rejects

8.1.         Note: See VD-020 and “Checkweigher Under-Over Bin” signs for instructions on product handling.

8.2.         All blisters that fall into the bin from the Blister Rework station must be de-blistered.

8.3.         Any blisters that fall directly on the floor cannot be reworked.

8.4.         Good tablets that have been de-blistered, sieved and inspected may then be reintroduced back into the process.

8.5.         All reject cartons are to be inspected, cartons must be opened to check for damaged blisters.  (Bad blisters can BE de-blistered.)  Cartons that fall directly on the floor must be rejected.

9. Cleaning the Blister Packing Line and the Cartonner

NOTE: The Line Cleaning checklist must be completed on all machines after the line is cleaned and prior to the Line Clearance taking place. Follow SOP MAN-055 and Form-160 for the checklist.

NOTE: The following product contact parts have shown to be contaminated with tablet active even though all visual signs of tablet residue have been removed. Therefore, all these parts must be thoroughly cleaned.

–                      Tablet Hopper (1)

–                      Vibrator Grid (2)

–                      Vibrator Chute (not in picture)

–                      Brush Box Infeed Hose (not in picture)

–                      Brush Box (6)

–                      Brush Box Paddles (not in picture)

–                      Plastic Trays underneath the Guide rail (not in picture)

–                      Tablet Guide plates (not in picture)

–                      Product Protruding Flap (not in picture)

All the above parts with the exception of the Brush Box Infeed Hose must be cleaned by spraying 70% IPA onto each separate part until the part is completely soaked. Take a clean Moisture Absorbent cloth and clean the part until it is dry.

Repeat the above step with a CLEAN Moisture Absorbent cloth. Use No less than 2 Cloths to clean the part. Do not use these cloths to clean the outside surface area of the product contact part.

Note : Refer to the following section for the specific cleaning requirements for certain parts listed above.

9.1.         Change of Product (Full clean down)

9.1.1.     Release Foil Transfer clamps. This is achieved by turning the Foil Transport function to OFF.

9.1.2.     Remove all the remaining components and waste from the line.

9.1.3.     Cleaning of the Brush Box and Associated Parts

Brush Box Infeed hose

Remove the Brush Box Infeed and Outfeed Adapters from the Brush Box Infeed hose. Flush the Infeed hose with hot water for no less than 1 minute. Shake all the excess water out of the tube. Spray the internal surface area of the tube with 70% IPA until it is soaked. Ensure all the tablet residue is removed. Leave the tube in a vertical position to dry.

Brush Box Wiper Brushes

NOTE: Gloves must be worn when handling the Brushes.
To dismantle, remove the perpex lids. Unscrew the knobs that are directly in front of each brush to remove the cover. The Brushes can then be removed. Inspect the bristles of the brushes for tablets and tablet fragments. Check that all the grub screws are still intact.

Paddle Manifold

To remove each Paddle motor and gearbox unit, unplug each connector hose. This will enable each unit to be lifted clear of the machine for cleaning.
Remove the vacuum hose and head for cleaning.

Turn the Paddle motor and gearbox units upside down so the paddles are facing up.

Unscrew the centre bolt for the Paddle motor and gearbox units

Remove the paddle manifolds slowly.

Clean the inside surface around the gears of each manifold with a cloth moistened with 70% IPA.

Use another cloth moistened with 70% IPA and clean the inside area again. Ensure all the tablet residue is removed. Ensure the internal surface area is completely dry before the 3 paddle manifolds are attached to the Paddle motor and gearbox units.

Brush Box Paddles

Spray 70% IPA over the complete surface of the silicon paddles until they are all completely soaked. Use a clean cloth and wipe the silicon surface dry.

Repeat the above step and use another cloth to dry the paddles completely. Use no less than 2 cloths to clean the silicon rubber paddles.

Do not let these cloths contact any other surface area, except for the paddle silicon rubber. If this occurs, replace the cloth and re-clean.

Product Protruding Flap

The product protruding flap can be cleaned by Spraying with 70% IPA over the entire surface area. Use a clean and new cloth and wipe the entire surface area completely dry. Repeat the above steps. Use no less than 2 cloths to clean the entire surface area. Ensure that all the tablet residue is removed.

Tablet Vibrator

Remove the cover from the Tablet Vibrator so the Sieve can be removed and any stray tablets can be cleaned out from the cavity underneath the Sieve. Spray 70% IPA onto all the product contact surfaces. Take a clean cloth and wipe all the areas until the tablet residue is removed.  Repeat the above step. Take another cloth and wipe all the surfaces until they are completely dry. Use no less than 2 cloths to clean all the product contact parts of the vibrator.

Tablet Guide Plate Cleaning

Spray 70% IPA onto the complete surface area of the guide plates until they are completely soaked, while the guide plates are still attached to the machine. Take a clean cloth and wipe down the complete surface area of the Guide Plates. Repeat the above step. Use no less than 2 separate clean cloths to clean the guide rails. Clean this part until all visual signs of the tablet residue and PVC dust are removed.

After the guide plates are clean, remove them from the machine.

Remove the Cutting Die and Perforating station.

Please Note: Make sure the washers are accounted for when removing each of these stations. emove the Heating station, if required.

CAUTION: the machine must have cooled down before you even attempt to remove the Heating plates.

To remove, unplug hose connections, undo the two bolts on top and the two bolts underneath.

Then slide the two Heating plates out.

Remove Coding plate.

Remove Sealing Die.

Remove the Forming Die.

Disconnect the Cooling Water hoses and the Air hose.

To remove top plate, undo the four bolts.

When undoing the last of the four screws, support the plate so it does not drop.

Ease the plate out gently to avoid damaging the hoses.

To remove the Bottom Die, release the clamp and ease the Die out gently.

Remove the Cover Plates when changing from Format three to Format four.

Remove Blister Transfer Arm, if changing from Format three to Format four or vice versa.

Remove the Coding Block from Cartonner.

Using vacuum, remove any remaining particles from the line.
Vacuum all removed machine parts, reject tubs and the surrounding floor.
When finished with the vacuum, hold the hose straight and with the vacuum on, clear any product left in the hose.

Clean all machines, all other machine parts, tubs, tweezers and utensils with 70% IPA and disposable wipes. Ensure all the tablet residue and dust is removed.

NOTE: Safety glasses and gloves must be worn when using IPA.

9.2.         Change of Batch Number (same product with different BPN)

10.2.1.   All components may remain on line, except for any tablets.

10.2.2.   Brush Box must be removed for cleaning.

10.2.3.   Coding Blocks must be removed.

10.2.4.   Sealing Die is to be removed for cleaning.

10.3.    Change of Code (same Manufacturer’s batch of tablets)

10.3.1.   Repeat the steps of a Change of Product (full clean down).

10.3.2.   NOTE: Guide plates will only need to be removed if the changeover is to a different Format.

10.3.3.   The Brush Box does not have to be dismantled.

10.4.    Cleaning the Brushes

Each product will have a set of dedicated Brushes.  The brushes will be cleaned at the end of a process by vacuuming . The brushes are to be washed as per the blister machine Preventative Maintenance schedule.

To wash the Brushes follow the following steps:

10.4.1.   To a large stainless steel bucket, add 100 mL 751N-liquid Cationic Sanitiser to each 15 litres of HOT Town water.

10.4.2.   Soak the Brushes for one (1) hour.

10.4.3.   Rinse the Brushes in hot water

10.4.4.   Give the brushes a final rinse with RO (Reverse Osmosis) water.

10.4.5.   Spin the Brushes until all excess water is removed.

10.4.6.   Give the Brushes approx. two working days to dry, and then store them back in the allocated area.

NOTE: The Line Cleaning checklist must be completed after the line has been cleaned, before a Line Clearance can take place.

10. Summary of Changes

Version #	Revision History
MAN-075	New