SOP For Double Cone Mixer

Standard Operating Procedure for a double cone mixer.

1.0 Purpose

The purpose of this SOP is to establish a standard procedure for operating the double cone mixer.

2.0 Scope

This SOP will be applicable for the double cone mixer in the granulation/Mixing  area of the production section.

3.0 Responsibility

3.1 Machine Operator is responsible for operating the mixer.

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.

4.0 Procedure

4.1 Production Pharmacist will ensure that the double cone mixer and the area is properly cleaned.

4.2 Production Pharmacist will ensure that the double cone mixer  and Area is labelled with Cleaned label status.

4.3 Before starting the operation of a double cone mixer, take line clearance from the QA officer and affix product related labels to the mixer and Area.

4.4 After line clearance, close the lower lid of the double cone mixer tightly.

4.5 Add materials to be mixed in a double cone mixer according to BMR.

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 double cone mixer to the power plug.

4.8 Set the time required for mixing according to BMR on the timer of the double mixer.

4.9 After setting the time,set the rpm for mixing according to BMR.

4.10 Press the start button to start the mixing process.

4.11 After completion of mixing time, the mixer will stop automatically,remove the wire from the plug.

4.12 Place a container below the lower lid of the double cone mixer and off load the mixed material in a polythene bag placed inside the container by opening the lower lid.

4.13 After complete removal of mixed material in containers, close the lid of the double cone mixer and affix it to be  cleaned label.

4.14 Record the activity in the logbook of the double cone mixer and sign it.

5.0 Abbreviations

5.1 SOP: Standard Operating Procedure

5.2 rpm:   Rounds per minute

5.3 BMR: Batch Manufacturing Record

5.4 QA: Quality Assurance

5.5HOP:Head Of Production