Roller Compactor Machine

Standard Operating Procedure (SOP) for cleaning and operation of Alexander werk GmbH (Germany) make Roller compactor machine.

1.0 Purpose :

- The purpose of this SOP is to lay down the cleaning and operation procedure for Roller Compactor.

2.0 Scope :

- This SOP is applicable for cleaning and operation of Roller compactor WP 200 Pharma, water jacketed, Make: Alexander werk GmbH (Germany).

3.0 References , Attachments & Annexures :

- References :

- Instruction manual – Roller Compactor Machine

- SOP of “Clearance of lines, Area and Equipment”

4.0 Responsibilities :

- Operator :

- To clean the Roller Compactor as per defined procedure.

- To operate the Roller Compactor as per defined procedure.

- Production Officer :

- To check cleaning and operation of the Roller Compactor as per defined

- To maintain all relevant equipment sequential log.

- Production Head or Designee :

- To ensure the proper implementation of the SOP.

- Quality Assurance :

- To ensure the proper cleaning and operation of the Roller Compactor.

- To ensure the maintenance of records.

5.0 Procedure – Operation and Cleaning of Roller Compactor

- Cleaning procedure of Roller Compactor for product changeover :

- Ensure that ‘To be Cleaned’ label is put on the machine.

- Push the button of Navigation to open the navigation menu, In navigation menu Cleaning mode is selected and push arrow button (^) to move the upper roller upward. Cleaning done only in manual mode.

- Ensure that the Emergency pressed during cleaning.

- Disconnect the inlet and outlet water supply.

- Clean external surface of drive assembly cover using moist cloth followed by clean lint free dry duster.

- Dismantle the Lower sensor, Hopper cover, Separation cover, Upper lid (Hopper) to remove any adhered material from the feeder assembly.

- Loosen the bolt and dismantle roller unit cover, granulator cover, mesh supporting rod, separation plate and remove any adhered materials if any with the help of plastic spatula.

- Dismantle the pre-granulator mesh, post- granulator mesh and open adjacent plate to open main cover, crusher guard and loosen Combivent feeder to open crapper (upper and lower) and remove any adhered materials if any with the help of plastic spatula.

- Loosen and dismantle the upper and lower roller, close the inlet of vacuum & compressed air point through nut and open pre and fine granulator.

- All dismantled part placed on pallet and covered with polybag and transfer to washing area and wash all above dismantled parts with running potable water on full open cork for NLT 15 minutes using nylon scrubber.

- Visually ensure the cleanliness. Repeat the process if any adhered material.

- Scrub all above parts with NLT 2 liters of 2% nonionic detergent solution using nylon scrubber.

- Wash all above parts with running potable water on full open cork for NLT 10 minutes to remove the detergent.

- Finally rinse all above parts with running purified water on full open cork for NLT 5 minutes.

- Clean thoroughly hosepipe and suction nozzle with running potable water on full open cork from one end to the other, both from inner and outer side.

- Then clean with 2 % v/v non-ionic detergent solution

- Rinse the hose pipes and suction nozzle with running potable water to remove the detergent

- Rinse the hosepipe and suction nozzle with running purified water.

- If the above parts is not cleaned, then cleaned the hose pipes with hot water and then repeat the above procedure.

- Clean all external surface of the equipment using compressed air.

- Visually ensure the cleanliness of the machine.

- After ensuring the satisfactory cleanliness of machine dry, all the parts using compressed air or allow it to air dry.

- Assemble the Roller Compactor.

Note: The cleaning of the machine remains valid for 48 hours. If the machine is not used within 48 hours then it should be re cleaned as per above procedure.

- Cleaning procedure for batch to batch changeover:

- Ensure that the mains switched `OFF’.

- Remove the protective plate for the Roller Compactor to remove any adhered material from the roller, pressure chamber and feeder assembly

- Wipe all external surface of the equipment using clean lint free dry duster.

- Insert protective plate for the roller compaction chamber in its position.

- Affix ‘ Partially Cleaned’ label on the machine

- After completion of cleaning of Area and Equipments as per defined procedure, fill the details in Line clearance record / Sequential log.

Note: The cleaning of the machine remains valid for 24 hours. If the machine is not used within 24 hours then it should be re cleaned as per cleaning procedure for product changeover.

Operating procedure of Roller Compactor:
- Checks and precautions:

- Wear the secondary gowning as per the secondary gowning SOP.

- Place a duly labeled container lined with polyethylene bag below the discharge end.

- Ensure that before starting of machine check all pressure lines and screwing of the hydraulic system for proper fixing, leakage & external damages.

- Make sure that the feed hopper is not overloaded and the level of the material does not go below the set mark

- Ensure that the Roller Compactor gap can be pre-set as required by using the roller gap control function.

- The gap should not be under 1.0 mm .

- This value kept constant during operation by an automatic adjustment of the screw speed.

- Ensure that if there is still material inside the machine, the aggregates may be switched on exclusively and only in the following sequence.

- - (i) Fine granulator

- - (ii) Pre granulator

- - (iii) Flake crusher

- - (iv) Roller unit, including roller cooling

- - (v) Hydraulics

- - (vi) CVF screw feeder, including vacuum system

- - (vii) CVF stirrer.

- Strarting the aggregates in any other sequence leads to blockage and damage of the machine.

- Operating procedure of Roller Compactor Machine:
- Ensure that ‘Clean card ’ label is put on the machine.

- Turn the main switch from position 0 in to the position I.

- The panel is now switched on & the monitor shows main menu.

- Press the login button & enter user name & password.

- Press the button Actuals in the navigation bar to show the actuals parameters of the machine and to change operating parameters, press the appropriate set point field and enter the desired value.

- Fix the charging hopper in its position.

- Press the batch control button of the action menu to start the batch mode.

- Start the machine in automatic operation mode.

- The machine starts running with the parameters of selected recipe. .

- Connect the water inlet and outlet connections to the point provided on the machine.

- Remove ‘Clean card ’ label and affix it in the BMR Affix ‘Area/Equipment’ label on the machine.

- Load the materials through materials transfer system in Combivent feeder stirrer unit, The air escaping out of the product through the screw feeder during compaction process.

- Start the pressure roller, the roller unit compacts the materials in the gap area of the press to a strip of flakes or crushed flakes .

- Depending on the compaction pressure, the speed of rotation of the rollers determines the thickness and hardness of flakes.

- Check the hardness of the flakes at regular intervals.

- The flakes coming from the roller unit are broken into smaller pieces between the arms of flake crusher and comb of lower scraper.

- The smaller flakes falling down in granulator unit, Unit A coarse granulator and Unit B is fine granulator .

- Pass the coarse flakes through the U-shaped screen.

- Determine the granules size of the granulate by the suitable mesh size.

- Collect the desired granules in polythene lined container with proper labeling.

- The fine granules collected in separate polyethylene lined container and again fed in to the Combivent feeder and repeat the process.

- After completion of the process switch `OFF’ the mains.

- Tie the poly bag and close the container

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