“Standard Operating Procedure for Vibro Sifter Operation and Cleaning in Pharmaceutical Production”

 

1.0 Aim

1.1 To establish a standard procedure for the operation and cleaning of the Vibro-Sifter.

2.0 Scope

2.1 This procedure is applicable to the operation and cleaning of the Vibro-Sifter within the production department.

3.0 Responsibilities

3.1 Operator

3.1.1 Responsible for operating and cleaning the Vibro-Sifter according to this SOP.

3.2 Officer/Executive

3.2.1 Ensure the proper implementation of this SOP.

3.3 Manager/Department Head

3.3.1 Ensure overall compliance with this SOP.

4.0 Principle of Vibro-Sifter

4.1 The Vibro-Sifter uses vibration, generated by an out-of-balance flywheel, to create horizontal rotary motion.
4.2 This process ensures the material is of uniform particle size and free of contaminants.

5.0 Operation Procedure

5.1 Attach S.S. Screen Mesh

5.1.1 Attach the appropriate S.S. screen mesh, as specified in the BMR for the product.

5.2 Adjust Vibration Amplitude

5.2.1 Adjust the vibration amplitude using the movable weight on the flywheel.

5.3 Pour Material

5.3.1 Pour the material onto the mesh with a scoop.

5.4 Collect Sifted Material

5.4.1 Collect the sifted material in a clean polyethylene bag placed in a clean container.

5.5 Discard Dust and Particles

5.5.1 Discard dust and other particles remaining on the screen.

5.6 Secure and Label Container

5.6.1 Secure the polyethylene bag with thread and close the container with a lid.
5.6.2 Label the container with the appropriate in-process label.

5.7 Clean Contact Parts

5.7.1 Clean the charging port, wire mesh screen, and other S.S. parts that come into direct contact with the product after sifting.

5.8 Clean Non-Contact Parts

5.8.1 Clean other parts of the machine using a vacuum cleaner.

6.0 Cleaning Procedure for Vibro-Sifter

6.1 Label the Equipment

6.1.1 Affix a “To be cleaned” label before starting the cleaning process and transfer the equipment and its parts to the wash area after usage

6.2 Power Off

6.2.1 Turn off the equipment’s power control and the main switch.

6.3 Prevent Water Spillage

6.3.1 Avoid spilling water on electrical components like the motor and starters.

6.4 Dismantle Parts

6.4.1 After sifting, disassemble the S.S. feed hopper, S.S. frame, sieve holder, and S.S. wire mesh sieve.

6.5 Remove Residue

6.5.1 Use a nylon brush to clear any residual powder from the walls and corners.

6.6 Wash with Potable Water

6.6.1 Wash all parts with  potable water, followed by purified water.

6.7 Scrub with Sponge

6.7.1 Clean the parts using a sponge and rinse with potable water

6.8 Final Rinse and Dry

6.8.1 Rinse all parts thoroughly with potable water to remove traces of the previous product.
6.8.2 Finish with a rinse of purified water and dry using air at 2.0 kg pressure.

6.9 Drain and Dry

6.10.1 Drain the water and dry all parts using an air blower.

6.11 Clean Exterior

6.11.1 Wipe the exterior of the sifter stand and motor assembly with a lint-free, wet cloth.

6.12

Affix clean label and record the cleaning details in the respective logbook and get the cleaning verified by executive and move the sifter to clean container area .

 

 

Abbreviation’s

S.S – Stainless steel

S.O.P – Standard operating procedure