Blister Packing Machine (BQS) -Cleaning & Operation

Standard Operating Procedure for Cleaning and Operation of Blister Packing Machine (BQS) used for the packing of the pharmaceutical drug products.

SOP for Blister Packing Machine (BQS)

1.0   PURPOSE:

    • The purpose of this SOP is to lay down the procedure for the cleaning and operation of the Blister Packing Machine (BQS).

2.0   SCOPE – SOP FOR BLISTER PACKING MACHINE (BQS):

    • This procedure is applicable to Blister packing machine model BQS at the pharmaceutical drug manufacturing plants.

3.0   REFERENCES- SOP FOR BLISTER PACKING MACHINE (BQS):

    • SOP for Gowning Procedure in Production Area
    • General Cleaning Procedure for Production Area (SOP)
    • Procurement, Handling, and Destruction of Rubber Stereos – SOP
    • SOP for Cleaning of Dispensing Equipment
    • Procedure for Type A and Type B Cleaning.     

4.0   RESPONSIBILITY:

    • Operator and Production personnel shall be responsible to set, operate the machine, checking overprinting details, and legibility of overprinting at regular intervals.
    • Production personnel shall be responsible to carry out leak seal test and check sealing plate temperature at regular intervals as defined in the BPR.
    • Operator and Production personnel shall be responsible to do cleaning as per laid down procedure as per defined in the BPR.
    • QA shall ensure the cleaning, operation, and proper line clearance as per the defined procedure.

5.0   ABBREVIATIONS & DEFINITION:

    • % : PercentageBlister Packing Machine
    • BPR: Batch Packing Record
    • BQS: Blister Quick through Servo
    • Cm2: Centimetre Square
    • Dept: Department
    • PMS: Packing Material Store
    • PRC: Print Registration Circuit
    • Type A Cleaning :
    • Equipment and area cleaning during batch to batch change over.
    • Type B Cleaning: Equipment and area cleaning during product to product change over.

6.0   PROCEDURE – SOP FOR BLISTER PACKING MACHINE:

  • Checks and Precautions during handling of Blister Packing Machine:

    • Check the Magnehelic gauge for pressure difference as mentioned as per the defined limit.
    • Ensure the environmental condition as per requirement.
    • Check the temperature of the forming Plate and sealing plate at a regular interval as specified in the BPR.
    • Maintain the temperature and % relative humidity as mentioned in the BPR.
    • Ensure that complete batch details are overprinted and legibility on each Blister.
    • Wear gowning as per SOP of “Gowning Procedure of Production Area”.
  • Cleaning procedure of Blister Packing Machine after the closing of operation at shift end:

    • Remove and transfer the tablets from the hopper through the vibratory system or manual in the double line polybag and tie the same in a duly labeled container.
    • Ensure that the electrical supply of the machine is ‘OFF’.
    • Remove tablets and pieces of foils or remnants of previous products lying on the blister packing machine, floor into the designated place, and clean the area.
    • Clean the machine hopper, bowl, and entire machine with a clean lint-free dry cloth.
  • Cleaning procedure (Blister Packing Machine) at the time of batch-to-batch changeover:

    • Remove all the Under Process Labels from the area and machine, put a cross mark on them, and tear it for disposal.
    • Remove the stereos of the previous batch from the machine and destroy as per SOP of “Procurement, handling, and destruction of Rubber Stereos”.
    • Return the leftover packing materials of the previous batch to Packing Material Stores on material return note through ERP system Return of Leftover Packing Material and makes necessary entries in BPR.
    • Remove dust collection tray laying beneath the bowl, empty it out and clean it with a dry lint-free cloth.
    • Collect the labels from containers and keep them in suitable poly bags and attached them with BPR.
    • Remove the empty containers of the previous product and affix a label “TO BE CLEANED” and transfer it to washing area for cleaning as per  SOP of “cleaning of Dispensing Equipment”
    • Clean the Product contact parts i.e. hopper with lid, bowl, wiper brush, channel, tablets transferring bowl/scoop, and hose pipe with a clean lint-free dry cloth /duster or vacuum cleaner wherever applicable.
    • Clean the entire machine with clean lint-free dry cloth/duster and ensure that there should not be any tablets/capsules or powder remnants on the machine and floor.
    • Use HARPIC and metallic wire brush followed by potable water to clean the upper sealing plate.
    • Affix “PARTIALLY CLEANED” status label to the machine.
  • Cleaning procedure (Blister Packing Machine) at the time of product-to-product changeover:

    • Remove all the under process labels from the area and equipment, put a cross mark on them, and tear it for disposal.
    • Affix ‘TO BE CLEANED’ status label on the machine.
    • Remove the stereos from the machine and destroy as per SOP of “Procurement, Handling, and destruction of Rubber Stereos”.
    • Return the leftover packing materials of the previous batch to Packing Material Stores on material return note through the METIS system as per the SOP “Return of Leftover Packing Material” and makes necessary entries in BPR.
    • Remove dust collector tray laying beneath the bowl, empty it out then dispose of the collected powder after necessary record in BPR.
    • Collect and remove the labels from containers and keep them in suitable poly bags and attach them to the BPR.
    • Remove the empty containers of the previous product and affix a label “TO BE CLEANED” and transfer it to washing area for cleaning as per SOP of “cleaning of Dispensing Equipment” 
    • Remove the container labels of the previous product and keep in the poly pouch.
    • Attach the labels of the poly pouch in BPR.
    • Remove the empty containers of the previous product and affix a label “TO BE CLEANED” and transfer it to the washing area for cleaning as per SOP of “cleaning of Dispensing Equipment”.
    • Dismantle the parts of machine i.e. hopper with lid, bowl with cover, guide track, nylon wiper brush, dust collection tray, hose pipe, tablet transferring bowl/scoop, filter and riser grill, and channel assembly as shown in the diagram and cover it with polybag with a “TO BE CLEANED” label and transfer the same to the washing area for cleaning.
  • Cleaning procedure of dismantled Part of Blister Packing Machine:

    • Cleaning steps:
    • Dislodging of Blister Packing Machine :

    • Mop all the dismantled parts i.e. hopper, hopper lid, bowl with cover, guide track, tablet transferring bowl/scoop, and dust collection tray with clean dry cloth/duster.
    • Physically check if any adhere materials are present or not.
    • Dispose of the adhere material physically by mechanical force with the help of clean cloth/duster.
    • After ensuring dislodging follow the wet cleaning step for cleaning before washing with potable water.
    • Wetting of Blister Packing Machine :

    • Wet all the dismantled parts i.e. hopper, hopper lid, bowl and bowl cover, guide track with potable water followed by   2% non-ionic detergent solution, and allow for soaking the parts in a suitable container for not less than 5 minutes.
    • Take the dismantled parts one by one and scrub it with plastic/nylon scrubber and rinse it with running potable water.
    • Finally, rinse all the above-dismantled parts with purified water.
    • Inspect the cleanliness and if found unsatisfactory repeat the process till the parts are cleaned.
    • Keep the washed parts in a clean container for draining the rinsed water.
    • Mop the parts with dry lint-free cloth/clean cloth.
    • Dry the cleaned dismantled part with compressed air, and transfer the dismantled part to polybag in the container, labeled with “Cleaned” to respective change parts area.
    • Cleaning of Nylon wiper brush – Blister Packing Machine:

    • Dislodging :
    • Mop the nylon wiper brush with clean dry cloth/duster.
    • Physically check if any adhere materials are present or not.
    • The adhering material shall be dislodged physically by mechanical force with the help of clean cloth/duster.
    • After ensuring dislodging follow the wet cleaning step for cleaning before washing with potable water.
    • Wet cleaning – Blister Packing Machine:

    • Wet the Nylon wiper brush in potable water for not less than 5 minutes in a suitable container so that all the debris gets wet if present.
    • Wash the brush with running potable water.
    • Finally, rinse the parts with purified water.
    • Visually inspect the bristles by rotating the wiper brush for its cleanliness.
    • If found unclean then re-clean the dirty parts by repeating the same process till it gets visually clean.
    • Dry the nylon wiper brush with compressed air and wrap with stretch film affix with a “clean” label. Keep it in the change parts area and document the same.
    • Cleaning of hose pipe, return riser filter, and grill of AHU.

    • Dislodging
    • Mop the hose pipe and return riser filter and grill with clean dry cloth/duster.
    • Physically check if any adhere materials are present or not.
    • The adhering material shall be dislodged physically by mechanical force with the help of clean cloth/duster.
    • After ensuring dislodging follow the wet cleaning step for cleaning before washing with potable water.
    • Wet cleaning of Blister Packing Machine:

    • Clean the hose pipe through running water and agitate after pouring potable water up to 50% of pipe length inside the pipe by closing one end and vice versa/or with the help of a bottle washing brush (long type). Finally dry with compressed air.
    • Rinse the return riser filter with running potable water followed by purified water.
    • Dry it through compressed air.
    • Wet the return riser grill with potable water in a suitable container for not less than 5 minutes.
    • Scrub the grill with a 2% non-ionic detergent solution and wash it with potable water.
    • Finally, rinse it with purified water.
    • Mop it by dry clean cloth and finally dry it by applying compressed air.
    • Transfer the cleaned change parts in the change part storage area duly labeled with a “CLEANED” label and wrapped with stretch wrap film.
    • Make a necessary entry in the Blister packing machine (BQS) change part issue cum return record.
    • The cleaning of cleaned change parts remain valid for 48 hours; if the change part is not used within 48 hours, then clean as per procedure before use.
    • Clean the machine body (non dismantle part) with clean lint-free wet cloth followed by clean lint-free dry cloth/clean cloth.
    • Area to be cleaned as per SOP of “General Cleaning Procedure for Production Area”.
    • Clean the sealing plate with a suitable cleaning agent by scrubbing with a metallic wire brush, followed by potable water.
    • Finally, rinse with purified water.
    • Affix ‘CLEANED” card to the machine.
  • Cleaning of Blister Packing Machine after maintenance in case of major breakdown:

    • Before giving the machine to maintenance/preventative maintenance remove the tablets and store them in container duly labeled.
    • Remove the foils from the machine and store the same in primary packing material trolley/cabinet.
    • Clean the machine as per product-to-product changeover procedure.
    • Clean the area as per SOP for “General Cleaning Procedure for Production Area”.
    • Affix “CLEANED” card to the machine and intimate QA department for line clearance.
  • Cleaning after maintenance in case of minor breakdown:

    • Clean the machine and area with clean dry lint-free cloth/clean duster.
    • Ensure whether any nut-bolts are lying on the floor.
    • Visual inspection of the area to be carried out and start the production activity.

Note: The cleaning of cleaned equipment remains valid for 48 hours; if the equipment is not used within 48 hours then it should be re-cleaned as per product-to-product changeover before use.

  • Change over  or assembling of  Blister Packing Machine :

    • Ensure that all the materials of the previous product are removed from the area.
    • Issue the change parts from the Change part room as per the layout no. and make necessary entry in the Blister packing machine (BQS) change part issue cum return record.
    • Assemble and set main cam, upper and lower forming plate, bowl plate, guide piece, guide track, feeding channel, upper and lower sealing plates, cooling plate, indexing drum and gear, punching tool on their respective positions.
    • Set the hopper, linear and rotary vibrator bowl, feeding drum, upper and lower forming and sealing plates, guide track, guide piece, printing roller unit, indexing roller, punching tool, perforation plate and NFD/Camera System on the machine.
    • Switch on the machine and maintain the sealing plate temperature as defined in BPR.
    • Regulate the pressure of the compressed air as per the requirement.
    • Prepare a “CLEANED CARD” for machine and area and do the necessary entries in the sequential log and BPR.
    • Intimate QA dept. for line clearance and wait for the approval.
    • Transfer all the containers of the batch and primary materials of the batch in the machine cubicle.
    • Check all the drums as per the BMR and primary packing material as per the material issue order.
    • Set the rubber stereos on the stereo drum.
    • Affix the “CLEANED CARDS” in the BPR and under process labels on the machine in a predetermined place.
    • Take the foil proof, check against the BPR, approve it first by the production department, and then verify it by the QA department.
    • Attach the sample of approved overprinting foil in the BPR.
  • Blister Packing Machine Operation:

    • When the previous run is to be continued:
      • Ensure that the previous run was of the same batch number of the same product and ensure the change parts are as per packing instructions.
      • Ensure that the material lying in the cubicle is of the same batch which is to be continued. Visually inspect the machine and the cubicle for cleanliness.
      • Check that the printing unit is ready along with the stereos of the particular/precious product and batch details.
    • When a new batch/product is to be taken on the machine:
      • Ensure that the temperature and % relative humidity is maintained in the machine cubicle as mentioned in the BPR.
      • Ensure that change parts are assembled properly and their layout is as per Packing Instructions.
      • Check that the printing/embossing unit is ready along with the stereos of the particular product and batch details.
      • Load the tablets/capsules in the hopper.
      • Switch on the machine and collect a few empty blisters and check for appearance, sealing, cutting printing, and PRC setting.
  • Start-Up of Blister Packing Machine (BQS):

    • Open the valves of chilled water supply & return and switch ‘ON’ the chilled water pump.
    • Open the valve of compressed air and check the air pressure in the main pressure gauge.
    • It shall not be less than 6.0 Kg/cm2.
    • Switch ‘ON’ the main power supply and push the Green colored Press Button (located on the control panel) to switch ‘ON’ the electric supply.
    • After switching on the main supply, following the ‘WELCOME’ screen will appear and along with communication status will be shown below the screen.
    • After communication has been established between the MMI and PLC, following ‘MAIN SCREEN’ will appear.
    • Ensure that the set temperatures of different parameters are entered.
    • Touch ‘ALARMS’ key and touch ‘ACK’ key to acknowledge the alarms if any emergency occurs.
    • The touch ‘KEYS’ icon screen will appear.
    • Enter the correct level of the password.
    • Select the required parameters by touching the respective icons. Icons with red color are in ‘OFF’ position and in green color are in ‘ON’ position.
    • Touch ‘MAINS’ key in the above screen to go to the main screen and check the actual temperature is achieved with respect to set value.
    • The main screen with the previous run recipe will appear.

    • Touch ‘EDIT’ icon on screen, the ‘DATA EDIT’ screen will appear.
    • Click the ‘CHANGE PARTS PARAMETERS’ icon in the screen, and ensure all parameters are correct as per the particular change part.
    • Touch arrow icon available on the right side of the screen to go to the next page and ensure all parameters are correct.
    • Then again touch the arrow icon to check the parameters of the next page.
    • Follow the screens and enter various values as per the specific product change parts requirement.
    • Set machine parameters as per references provided in setting a chart of the change parts assembled for a particular product on the machine.
    • Load forming and lidding film roll and pass them through specified stations.
    • Run the machine to set matching of forming and sealing stations to get sealed blisters.

    • Collect initial empty blisters of around 10 to 15 strokes and check them physically for any visual defects generated due to knurling, cutting, sealing, printing, mismatching, etc.
    • Stop the machine and reset for the desired quality output.
    • Take empty blisters of two sealing cycles from above stated 10 to 15 strokes and perform leak seal test as per SOP.
    • If failure observed then adjust the parameters like temperature, pressure, alignment, etc. to get the desired results.
    • After the initial run, if the machine setting found to be satisfactory then set the Camera system as per SOP on “Setting and Operation of Camera System for Blister Packing Machine”.
    • Perform the in-process quality checks at regular intervals of time as specified in BPR and make necessary entry in BPR.
    • Defoil all the rejected blisters generated during machine operation, sort out, and pack again.
    • Collect the recoverable rejection is duly labeled double polybags and make necessary entry in BPR and ERP system and then transfer the same to the granulation department.
    • Collect the non-recoverable rejection, fines, and tablets used for leak seal test, destroy the same after making a necessary entry in BPR.
  • Shut Down of Blister Packing Machine:

    • In the case of drum feeding, touch the feed drum to the “OFF” position in the main operation key screen to stop feeding.
    • In the case of channel feeding, make sure that the upper inlet block, channels, and outlets chute are empty and ensure that all filled/good blisters have crossed the punching station.
    • Unload the tablets/capsules from the hopper of the machine and keep it in double polyline labeled container/s and twist tie the polybag.
    • Push the “MACHINE OFF” button in the MMI control panel when all filled blisters have crossed the punching station. Affix “TO BE CLEANED” tag on machine and room as per SOP.
    • Switch off the chilled water supply pump and close the valves of chilled water supply and compressed air.
    • Log off/shut down the camera system.
    • Push a red-colored press button (located on the control panel) to put the “OFF” into the main electric supply.

7.0   ANNEXURES – BLISTER PACKING MACHINE :

Annexure 1: Change Parts List

  • CHANGE PARTS LIST FOR BQS MACHINE:
SL. NO.

CHANGE PARTS

1 Forming plate (lower and upper)
2 Sealing plate (lower)
3 Feeding channel
4 Bowl plate
5 Printing drum
6 Guide track
7 Punching tool
8 Main cam
9 Cooling plate
10 Indexing drum
11 Indexing change gear
12 Guide piece
13 Feeding drum with back supporting plate
14 Feeding channel spring
15 Perforation unit
16 Indexing flap
17 Feeding box
  •  PARTS TO BE DISMANTLED:
SL. NO. CHANGE PARTS
1 Hopper and lid
2 Bowl disc with cover
3 Guide track
4 Nylon wiper brush
5 Dust collection tray
6 Hosepipe
7 Channel assembly/feeding channel spring
8 Feeding drum with back supporting plate
9 Feeding box for wiper brush
  • Dismantled parts to be inspected during line clearance :
01 Hopper and lid
02 Bowl disc with cover
03 Feeding channel
04 Guide track
05 Feeding box
06 Nylon wiper brush
07 Dust collection tray
08 Feeding drum
09 Inspection tray
10 De blistering machine
  • Inspection of assembled parts:
01 Product view window in the hopper
02 Area below vibrator
03 Vibrator guard
04 The surrounding area of the electric wire panel.

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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