Hand Capsule Filling Machine, Purpose :
Hand Capsule Filling Machine, The purpose of this SOP is to define the operation, cleaning and maintenance procedure of manual capsule filling machine. Model: PCF 300
Hand Capsule Filling Machine, Scope :
This SOP is applicable for operation, cleaning and maintenance procedure of manual capsule filling machine in product development laboratory of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]None
Responsibilities:
[][]The roles and responsibility is as follows:
Operator/Supervisor Product Development
[][]Operation and cleaning of the Manual Capsule Filling Machine
[][]Maintaining operation and cleaning log book
Executive/ Sr. Executive Product Development
[][]Checking and ensuring that the operation and cleaning is performed according to the SOP.
[][]Checking the log book.
[][]Preparation and timely review of the SOP.
Assistant Manager Engineering
[][]Preparation of maintenance schedule and maintenance of the machine.
Manager, Quality Assurance
[][]Ensure that the SOP reflects actual operation, cleaning and maintenance procedure.
[][]Approve the SOP against XX Pharmaceuticals Ltd. master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure:
Machine Assembling
[][]Before operation assemble the machine change parts that are necessary for certain type of operation.
[][]Attach the required type of change parts for the expected operation in the machine
Machine Setup
[][]Tag the filling machine with a Machine Label before use.
[][]Arrange empty capsule shell on the loading tray.
[][]Place the loading tray with empty capsule on the machine.
[][]Grip cam lever and pull towards the front.
[][]Push the inner slide knob.
[][]Depress the lifting plate lever.
[][]Lift the loading tray up.
[][]Separate the capsule bottom half (Bodies) from the cap.
[][]Check the entire cap and bodies are separated.
[][]Keep the loading tray with separated cap on the table carefully.
[][]Release the lever to drop down the bodies to sit in level with the top section.
[][]Place the filling tray on the machine. Ensuring the tray is properly located in holes provided in the top section.
[][]Pour the pre-weighed Powder /Pellet
Machine Operation for powders
[][]Spread the powder using Teflon dispenser over the top section to fill the body uniformly.
[][]If any powder remains on the tray, take aside the excess powder with the powder dispenser on to the platform provided on the right of the tray. Lower the pin plate assembly and lock it in position using pin plate locking lever to compact the powder.
[][]Unlock the lever, open the pin plate and spread the remaining powder (if necessary follow further step: 10.4.1. and 10.4.2.).
[][]Remove the filling tray. Place the loading tray with separated cap on the top section.
[][]Pull out the inner slide knob.
[][]Lower the pressure plate and lock in position with locking lever.
[][]Move the lifting plate lever downward for proper locking of the capsule.
[][]Unlock the pressure plate and take it back to its original position.
[][]Push the inner slide knob.
[][]Depress the lifting plate lever.
[][]Lift the loading tray up with locked capsule.
[][]Empty the locked capsule into a suitable container
[][]Remove the product container. Use plastic bag to wrap under the discharge chute. Clean the sieve to remove the materials that cannot pass though the sieve (If product is very sticky, the sieve might require to be removed for a thorough cleaning with brush and cleaning agent).
[][]Clean the machine after completing the operation of the day or before changing to process other products.
Machine operation for pellets.
[][]Spread the pellets using Nylon brush over the top section to fill the body uniformly.
[][]Remove the filling tray. Place the loading tray with separated cap on the top section.
[][]Pull out the inner slide knob.
[][]Lower the pressure plate and lock in position with locking lever.
[][]Move the lifting plate lever downward for proper locking of the capsule.
[][]Unlock the pressure plate and take it back to its original position.
[][]Push the inner slide knob.
[][]Depress the lifting plate lever.
[][]Lift the loading tray up with locked capsule.
[][]Empty the locked capsule into a suitable container
[][]Clean the machine after completing the operation of the day or before changing to process other products.
Machine Dismantling
[][]Remove the powder tray.
[][]Open the cam lever.
[][]Remove the eccentric pin.
[][]Remove the top section by loosening four screws.
[][]Pull out sliding sheet from the top section.
Machine Cleaning
[][]If the machine doesn’t used within 15 days after cleaning, then the machine should be cleaned on the 15th day.
[][]Wash the powder tray, cam lever, top section with sliding sheet, nylon brush, powder dispenser and the main body (lifting plate assembly, pin plate assembly and pressure plate assembly) with potable water.
[][]Wipe with damp markin cloth by rubbing to remove any adhering materials
[][]Wash with potable water again
[][]Wash with hot water using damp cloth to remove any insoluble material
[][]Wash with hot water and then with purified water.
[][]Wipe with clean, dry markin cloth to remove any water
[][]Dry with compressed air where necessary
[][]Wrap with poly bag, attach “CLEANED” label and store in the accessories cabinet.
[][]Clean eccentric pin with cotton cloth and lubricate it.
[][]Push the sliding sheet into the top section.
[][]Mount the top section onto the main body by four screws.
[][]Assemble the eccentric pin and cam lever.
[][]Keep the loading tray and powder tray with attached “CLEAN” label in accessories cabinet.
[][]Attach “CLEANED” label in the machine in store in the Table.
Annexure: Hand Capsule Filling Machine
Annexure – I: Operation and cleaning log book.