Compression Machine : Operation and Cleaning SOP

Standard Operating Procedure (SOP) for Cleaning and Operation Procedure for double rotary Tablet Compression Machine (45 And 55 Station).

Operation and Cleaning Procedure of Tablet Compression Machine

1.0   PURPOSE:

    • To lay down the efficient cleaning and operation of Double rotary compression machine Cadpress 45/55 stations Mark IV.

2.0   SCOPE:

    • This procedure is applicable for the cleaning and operation of Double rotary compression machine Cadpress 45/55 stations Mark IV.

3.0   REFERENCES:

    • Equipment Manual
    • SOP for Identification and Status Labelling Procedure.

4.0   RESPONSIBILITY – SOP FOR COMPRESSION MACHINE:

    • The operator shall be responsible for the cleaning and operation of the machine as per the defined procedure.
    • The production officer shall be responsible to ensure cleaning and operation of the machine as per the defined procedure.
    • The production officer shall be responsible to maintain the sequential log of the machine.
    • QA shall be responsible to ensure cleaning and operation of the machine as per the defined procedure.
    • The production officer shall be responsible to carry out in-process checks during the compression.
    • QA shall be responsible to give line clearance in case of product to product changeover and batch to batch changeover.

5.0   ABBREVIATIONS- SOP FOR COMPRESSION MACHINE:

    • IPA: Isopropyl AlcoholTablet Compression Machine
    • IPC: In Process Containers
    • QA: Quality Assurance
    • QC: Quality Control
    • RH: Relative Humidity
    • SS: Stainless Steel
    • TBC: To Be Cleaned

6.0   DEFINITION:

    • Cleaning:

    • The removal of the residual product or extraneous matter including microbial contamination from the facility surfaces and/or equipment to an acceptable level and maintaining the condition of the facility or equipment such that it can be used safely for subsequent use.
    • Clean-In-Place:

    • A process using a cleaning agent in a pumping system that circulates the solutions through process lines or process equipment in order to clean them without relocation or disassembly.
    • CIP cleaning may be performed using a fully automatic stand-alone cleaning system, or maybe performed by a manually controlled cleaning process where the washing/rinsing steps are initiated by manual manipulation of the various valves.
    • Cleaning Tool:

    • The tool most commonly used for the removal of soils and the application of disinfectants or sanitizers to floors, walls, etc.
    • Tools must be either disposable or capable of being easily cleaned to render them microbiologically sanitary between uses.
    • Equipment:

    • A device that operates either as a “standalone” or combines several instruments or pieces of equipment to give an output. The equipment performs a unit operation or many unit operations.
    • Purified Water:
    • Obtained by distillation, reverse osmosis, or ion exchange. Purified water is prepared from water complying with regulations for drinking water.
    • It must meet compendial tests for chemical and microbiological purity.

 7.0   PROCEDURE – SOP FOR COMPRESSION MACHINE:

    • Checks and Precautions – Compression Machine:
    • Ensure that die locking screws are not loose it may lead to accident.
    • Ensure that punches are freely moving in the dies and cam tracks.
    • Set the force feeder/ feed frame of the compression machine in such a manner to avoid friction with the turret.
    • Wear the secondary over gowning before starting the operation.
    • Do not clean the compression machine in the running condition.
    • Do not leave any granules in the hopper in case of a stoppage of the compression machine for the undue period and at the shift end.
    • Cleaning Procedure of Compression Machine:

    • For Product to Product Changeover:
    • Switch OFF the main electric supply to the compression machine.
    • First, check the emptiness of hooper and filling the chute.
    • Remove Under Process labels from the compression machine, and respective areas and fix ‘TBC’ labels on them.
    • Disconnect the hopper transfer it to change part trolley. Transfer to the washing area.
    • Finally, wash with purified water, and then dry it using compressed air or clean dry lint-free duster.
    • Release hydraulic pressure on the pressure rollers.
    • Collect and label the non-recoverable powder and tablets from the compression machine and destroy it as per the SOP of handling and destruction of Non-recoverable recovery.
    • Record the quantity of non-recovery in the BMR.
    • Collect and label the recoverable powder/tablets from the compression machine and handled as per SOP of ‘Handling and use of residual recovery”.
    • Dismantle and remove hopper, force feeder, scrapper plate, acrylic parts, lower cam guards, discharge chutes, parts of the dedusting machine, and transfer to change part trolley duly labeled with ‘TBC label’.
    • Transfer this change part trolley to the washing area.

    • Wash all the parts using 2% non-ionic detergent followed by potable water and finally rinse with purified water.
    • Dry the parts with a clean dry lint-free cloth or with compressed air or with hot air.
    • Remove leftover powder from the compression machine using dry cloth/blower/compressed air.
    • Remove dust cup respective upper punch one by one and clean each punch along with dust cup with IPA soaked cloth followed by dry lint-free cloth and put them horizontally on die-punch handling tray duly labeled with details of punch specifications and their quantities.
    • Take out all the lower punches one by one by rotating the turret manually and clean each punch with IPA soaked cloth followed by dry lint-free cloth. Put the punches on the die-punch handling tray in a horizontal position.
    • Unscrew the die locks and remove all the dies one by one with the help of die bar. Put the dies on the die-punch handling tray after cleaning them with IPA followed by dry lint-free cloth.
    • Transfer this die-punch handling tray to the tool room. Lubricate the punches with liquid paraffin and store them in the respective die-punch storage cabinet.
    • In case the same punch set is to be used for the next product, clean the punches and dies with IPA, wipe out the IPA with a dry cloth.
    • Clean the upper punch and lower punch guide holes and die holes thoroughly with IPA using a bottle brush. Clean the cam tracks and turret with IPA using a lint-free cloth.
    • Finally, wipe with a clean dry lint-free cloth.

    • Clean all the exposed parts of the compression machine excluding the PLC screen with IPA wet cloth followed by a dry cloth.
    • Wipe analytical balance, the container of mask and gloves, tablet inspection plate, and trolley with IPA soaked cloth followed by a clean dry cloth.
    • After QA approval remove the label from the compression machine, area, and affix ‘Cleaned’ label.

Related: SOP for Status Label in Production

    • Record the cleaning of the compression machine in a sequential log and equipment cleaning record and take QA approval for cleaning.
    • After QA approval remove ‘Cleaned’ label and affix in BMR, which is to be counter checked by QA.

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

    • For batch to batch changeover:

    • Switch OFF the main electric supply to the compression machine.
    • First, check the hopper emptiness
    • Fix ‘TBC’ label on the compression machine and respective areas a
    • Release hydraulic pressure on the pressure rollers.
    • Collect and label the non-recoverable powder tablets from the compression machine and destroy it as per the SOP of handling and destruction of Non-recoverable recovery.
    • Record the quantity of non-recovery in the BMR.
    • Collect and label the recoverable powder/tablets from the compression machine and handled as per SOP of ‘Handling and use of residual recovery”.
    • Ensure that no compressed tablet remains in the dedusting unit.
    • Remove the force feeder.
    • Clean upper punches one by one along with a dust cap.
    • Remove any excess powder from the turret and the compression machine using blower or by dry cloth or with compressed air.
    • Affix ‘Partially Cleaned’ card on the compression machine, area, and take QA approval for cleaning.
    • Record the cleaning in the Equipment Sequential Log.
    • After QA approval remove ‘Partially Cleaned’ card and fix it in the BMR and then affix the ‘Area/Equipment’ status label which is to be counter checked by QA.

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

    • Change Part Trolley Cleaning Procedure during product to product changeovers:

    • After cleaning of all desalted parts, clean the change part trolley with 2% non-ionic detergent, then with potable water and finally rinse it with purified water.
    • Dry the change part trolley with a dry lint-free cloth or with compressed air or with hot air
    • Then transfer the cleaned part to it and close the doors and transfer it to compression cubicle.

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

    • After maintenance of Compression Machine:

    • If the product part is repaired then clean the compression machine as per the procedure laid down for Product Change Over.
    • In case any welding is done on the product contact parts clean as per SOP of cleaning of newly received SS fabricated parts/equipment/ machines.
    • For maintenance of non-contact parts clean the compression machine to be free of oil,grease marks and ensure to cover the machine with the plastic sheet.
    • Assemble the Compression Machine as below:

    • Take out and check the required punches as per the BMR from the punch storage cabinets.
    • Clean die and punches with IPA soaked cloth and finally with the dry lint-free cloth.
    • Fix all the dies on the turret one by one.
    • In case of other than round shape punches, the die should be positioned with the help of upper punches.
    • Lock the dies tightly.
    • Do not use any pipe or spanner for tightening the die locks.
    • Use only Allen keys.
    • Insert lower punches one by one through the lower punch loading hole.
    • Ensure that the lower punches go in the die smoothly.
    • Once all the lower punches are inserted and Insert the brake plugs and fix the anti turning springs over it to hold the lower punches and lock it.
    • Fix the scrapper plate keeping minimum clearance to avoid powder leakage below it and also to avoid its friction with the turret.
    • Now adjust the granules recirculating band with scrapper blade.
    • Insert the upper punches in the upper punch holes and ensure the smooth movement. (In case of other than round shape punches, upper punches inserted along with the dies).
    • Fix all the lower guards.
    • Fix discharge chute assembly.
    • Assemble force feeder and fix it on the compression machine.
    • Fix the hoppers over the force feeder.
    • Rotate the compression machine manually and ensure the free movement.
    • Attach the cleaned dedusting unit with the compression machine.
    • Operating Procedure of Compression Machine:

    • Setting & operating the compression machine after the changeover:
    • Ensure that the AHU and dust collector is ON.
    • Check the temperature and %RH of the cubicle and record.
    • Fix the lubricated granules in hopper after verifying the label of the IPC as per the BMR and counter checking the weight of the IPC with respect to BMR, and fix it with t flow the granules in the hopper.
    • Then feed the granules in hopper manually, in case of lubricated granules store in IPC, and open the hopper valves to feed the feeders.
    • Switch ON the mains of the compression machine and switch on the main motor of the machine.
    • Enter the password in PLC to operate the compression Machine.
    • Apply the hydraulic pressure on Cadpress 45/55 as per BMR or as per Annexure-1.
    • In manual mode of feeder, feed the granules in the feeders.
    • Once the force feeder are filled with the granules change from manual mode of feeder to auto mode and start the compression machine by pressing the switch for few seconds and again stop the machine by stop switch.
    • Discard the initial 2 rounds tablets as non-recovery.

    • Place appropriately labeled double polyethylene lined clean HDPE containers at the outlet of the dedusting machine to collect the tablet.
    • In case the dedusting machine is not used, collect the tablets in the perforated SS bowl.
    • After the bowl is filled with the tablets, dedust the tablets manually and transfer the dedusted tablets in to appropriately label double polyethylene lined clean HDPE containers.
    • Again start the compression machine and collect a few tablets from the both sides.
    • Check these tablets for weight and thickness.
    • Accordingly set the weight hardness and thickness with the help of weight dozer and pressure wheel respectively.
    • Repeat the above step till the correct desired weight, hardness, and thickness achieved.
    • Once the weight, thickness, and hardness of the tablets are set, check the physical appearance & other parameters as per BMR.
    • Adjust all the parameters as per requirement in the BMR.

    • Keep all the above tablets in a separate bag and label as recovery.
    • Once all the parameters are set properly, then take approval from QA for setting parameters.
    • After QA approval starts the machine.
    • In case, the dedusting machine is attached to the machine. start dedusting machines and then start the compression machine.
    • During the end run of the batch, crush the recovery collected during the operation in clit mill through a suitable screen size and mix it with approx.
    • Double quantity of the fresh granules in a polybag and then compress those to tablets.

                 Note: Do not run the compression machine without powder in the feed frame/force feeder.

    • Stoppage of Compression Machine during breaks:

    • Switch ‘Off ‘the machine and dedusting machines (In case in use ).
    • Switch ‘Off’ the machine mains.
    • Close the containers of the granules and tablets with lids.
    • Switch ‘Off’ the lights of the cubicle.
    • Stoppage of Compression Machine at the end of the shift:

    • Switch ‘Off’ the machine and dedusting machines (In case in use).
    • Switch ‘Off’ the mains and disengage from the socket, if required.
    • Remove the granules from the hopper, turret/feeders, and keep them in granules container in case of hygroscopic/corrosive products.
    • Clean the machine externally with dry duster/vacuum cleaner.
    • Switch ‘Off’ the lights of the cubicle.
    • Switch ‘Off’ all electrical connections of the cubicle.
    • Close the valve of the hopper.
    • A restart of Compression Machine after the break:

    • Switch ‘On’ the lights of the cubicle.
    • Switch ‘On’ the main power supply to the machine.
    • If used, Switch ‘On’ the dedusting machines.
    • Start the compression after checking the Tablet Avg. weight.
    • At the end of the completion of the batch:

    • Switch ‘Off’ the machine.
    • Switch ‘Off ’ the dedusting unit.
    • Remove all the tablets from the dedusting machine.
    • Collect tablets in suitably labeled polybag lined containers.
    • Collect and label the non-recoverable powder and tablets from the machine and destroy it as per the SOP of handling and destruction of Non-recoverable recovery.
    • Record the quantity of non-recovery in the BMR.
    • Collect the recovery from the force feeder, turret, and dedusting machine.
    • Label the recovery and store it in the recovery room. Record the qty. of recovery in the BMR.
    • Remove all the filled & empty containers from the cubicle.
    • Weigh each and every container and record it in the BMR.
    • Transfer empty containers in the washing area for washing.

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

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