Friday, May 28, 2021

SOP For Sigma Blade Mixer/Spiral Mixer

Standard Operating Procedure for sigma blade mixer/spiral mixer,plough mixer or H mixer.

1.0 Purpose

The purpose of this SOP is to establish a standard procedure for operating the sigma mixer/spiral mixer,plough mixer or H mixer.


2.0 Scope

This SOP will be applicable for the sigma blade mixer/spiral mixer/plough mixer or H mixer. installed in the granulation area of the production section.


3.0 Responsibility

3.1 Machine Operator is responsible for operating this mixer.

3.2 Production Pharmacist is responsible for implementation of this SOP.

3.3 Head Of Production 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 Sigma blade mixer or spiral mixer and area is properly cleaned.

4.2 Production Pharmacist will ensure that the sigma blade mixer or spiral mixer and Area is labelled with Cleaned label status.

4.3 Before starting the operation of sigma blade mixer take line clearance from the QA officer and affix product related labels to the mixer and Area.

4.4 After line clearance Switch ON the electric power supply of the mixer.

4.5 Open the lid of the sigma mixer and ensure proper fitting of all parts.

4.6 Load the sieved material in the bowl of the spiral mixer which is required to be granulated.

4.7 Close the lid of the spiral mixer and Start dry mixing of sieved material by switching ON the Start Mixing Button to rotate the blades of the mixer

4.8 Set the rpm of  blades and mixing time according to the BMR.

4.9 After set time mixing of the product will stop automatically.

4.10 Again open the lid of the spiral mixer and carefully sprinkle or pour binder solution over the dry mixed powder while blades are in rotation.

4.11 Continue this granulation process for the time mentioned in BMR or till the desired end point to achieve good quality granules.

4.12 Stop the mixing process after the specified time period or when  the end point of wet granules is achieved.

4.13 Tilt the bowl of spiral mixer by rotating the knob and Place SS tub below it to collect granules.

4.14 Collect all the wet granular material in the SS tub with the help of scops.

4.15 Properly clean the sticky material from the walls of the bowl and blades.

4.16 After complete removal of granules from the mixer reset the bowl position to upside by rotating the knob.

4.17 Close lid of sigma blade mixer.

4.18 Put OFF the electric power supply of the mixer.

4.19 Affix to be cleaned Label to the sigma mixer.

4.20 Record the activity in the logbook of the sigma 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

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