Wet and Dry Granulator , Purpose:
Wet and Dry Granulator , The purpose of this SOP is to define the operation and cleaning procedure of Wet and Dry granulator.
Wet and Dry Granulator , Scope:
This SOP is applicable for operation and cleaning procedure of Wet and Dry granulator in product development of XX Pharmaceuticals Limited.
Definition / Abbreviation:
[][]None
Responsibilities:
[][]The roles and responsibility are as follows
Operator/Supervisor Product Development
[][]Operation and cleaning of the Wet and Dry granulator
[][]Maintaining operation and cleaning log book
Executive/ Senior 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.
Manager, Quality Assurance
[][]Ensure that the SOP reflects actual operation and cleaning procedure.
[][]Approve the SOP against XX Pharmaceuticals Limited master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure:
[][]Machine Assembling
[][]Before operation assemble the machine accessories that are necessary for operation.
[][]Place the appropriate granulator head that is Wet head or Dry head.
[][]Place the appropriate sieve in the head.
[][]Securely lock the main head body to the driving shaft.
[][]Clamp down or tighten each component in place and insert the desired sieve with correct mesh size.
[][]Tightened the blade, hopper and body.
[][]Switch on the machine check that the granulation head rotates smoothly and there is no abnormal noise heard.
Machine Operation
[][]Switch on Main Breaker to supply main power to the system.
[][]Place a product container underneath the granulation head.
[][]Wrap the discharge chute with lint-free cloth which allows air to flow through. This will make the product flow penetrating into the product container without dispersing in the air.
[][]Press Start (Green push button) to activate the granulation head. The head will start rotating.
[][]Gradually load material into the granulation head from the top side.
[][]Observe that material loading rate should synchronize with granules output rate, that granule present through the discharge chute into the product collection bin.
[][]Loading product faster in the granulation head will results finer particles than the desired.
[][]The granulation rate varies depending on sieve size used and product characteristics.
[][]After charging all material into the machine and all are discharged, press Stop (Red push button) to discontinue the granulation process. The main shaft will stop rotating.
Machine Cleaning
[][]If the machine doesn’t used within 15 days after cleaning, then the machine should be cleaned on the 15th day.
[][]For safety purpose, cut off the main breaker that supply electricity to the machine before commencing the cleaning operation.
[][]Removing Granulation head from the main machine and bring it to the cleaning area.
[][]Disassemble each component for cleaning separately.
[][]Clean each component with fresh running potable water, hot water finally Purified water. Spatula (scraper) and cleaning agent might be required to remove sticky material attached on the surface.
[][]Do not submerge Granulation head into water bath. Water will penetrate into the bearing housing and cause rust, bearing service life of bearing will be lessened and machine will not operate smoothly.
[][]Spatula (scraper) or cleaning brush used with the machine must be made of only of plastic, rubber or materials that do not generate scratches or damage to the mirror-polished surface.
[][]Sieve should be thoroughly clean and ensure that no material stuck in the perforated holes and wire net.
[][]Repeat cleaning if necessary until the granulation head is completely cleaned.
[][]Use soaked cloth to clean the main granulation machine. Care must be taken that no water enters the control box and motor housing.
[][]Wipe each component with clean and dry cloth to remove the remaining water. Start wiping the critical area that is product contact parts first, following by non-product contact area.
[][]Apply compressed air or heated air to expedite the drying rate. Otherwise, leave each component to dry up in the clean operating room.
[][]Re-wash the machine with purified water as required. Finally rinse with purified water.
[][]Fix ‘CLEANED’ label on the machine.
[][]Keep the record of machine operation and cleaning according to the Annexure – I of this SOP.
Annexure:
Annexure – I: Operation and cleaning log sheet of Wet and Dry granulator