Standard Operating Procedure for Bin Blender or IBC Blender.Bin blender is also known as IBC.
The purpose of this SOP is to establish a standard procedure for operating the Bin Blender or IBC Blender
This SOP will be applicable for the Bin Blender / IBC Blender in the granulation or Mixing area of the production section.
3.1 Machine Operator is responsible for operating the blender.
3.2 Production Pharmacist is responsible for implementation of this SOP.
3.3 HOP is responsible to ensure the implementation of this SOP.
3.4 Quality Assurance Officer monitors the compliance of this SOP.
4.1 Production Pharmacist will ensure that the Bin Blender or IBC Blender and the area is properly cleaned.
4.2 Production Pharmacist will ensure that the Bin Blender or IBC Blender and Area is labelled with Cleaned label status.
4.3 Before starting the operation of a Bin blender, take line clearance from the QA officer and affix product related labels to the blender and Area.
4.4 After line clearance, tightly close the lower lid of the bin blender or IBC blender.
4.5 Load materials to be mixed according to BMR in the bin blender.
4.6 After addition of material, close the upper lid tightly.
4.7 After ensuring that both lids are tightly closed, connect the electric wire of the bin blender to the power plug.
4.8 Ensure that the bin of the blender is tightly screwed in the lifting arms of the blender.
4.9 Press the lifting button on the HMI of the blender and lift the blender till it’s recommended height for mixing.
4.8 Set the time required for mixing according to BMR on the timer of the bin blender.
4.9 After setting the time,set the rpm for mixing according to BMR.
4.10 Press the start button on HMI to start the mixing process.
4.11 After completion of mixing time, the mixer will stop automatically.
4.12 Press the lifting button on HMI to bring the blender at the height recommended for unloading of the batch.
4.13 Place a container below the lower lid of the blender,open the valve of the lid and off load the mixed material in the container.
4.13 After complete removal of mixed material in containers, close the lid of the bin blender and affix it to be cleaned label.
4.14 Record the activity in the logbook of the double cone blender and sign it.
5.1 SOP: Standard Operating Procedure
5.2 rpm: Rounds per minute
5.3 BMR: Batch Manufacturing Record
5.4 QA: Quality Assurance
5.5 HOP: Head Of Production
5.6 IBC: Intermediate Bulk Container