Month: October 2020

Cleaning procedure for Vibratory Sifter

1.0       OBJECTIVE

1.1        To lay down a cleaning procedure for Vibratory Sifter

2.0       RESPONSIBILITY

  • Technical Assistant – To follow the SOP & Cleaning of sifter.
    • Executive – To verify the Cleaning of sifter
    • Executive – Responsible for compliance of SOP

3.0     PROCEDURE:

   TYPE “A” CLEANING (Dry Cleaning/Batch to batch Cleaning):

   Ensure that status label is updated as “TO BE CLEANED”.

  Ensure that sifter main is switched off before cleaning.

 Remove labels, materials and containers of previous batch from the sifting area.

Remove any adhering material from the outer surface of sifter using vacuum cleaner.

Wipe out the adhered powder from outer surface of the sifter using dry lint free cloth.

Record the cleaning details in equipment log sheet. Take the line clearance from QA department before starting the next operation.

Frequency of Cleaning:

  • Shall be performed between batch-to batch changeovers.
  • At the end of a particular operation in the batch
  • At the end of the day.
  •  Before type “C”cleaning.

 TYPE “C” CLEANING ( Wet Cleaning/Product to product Cleaning:

  • Ensure that status label is updated as “TO BE CLEANED”.
  • Ensure that sifter mains are switched off and cover all the electrical points with polythene cover.
  • Remove any material, labels and containers of previous product from the area.
  • Release the upper most clamps and remove the upper lid.
  •  Release the lower clamp and remove the top hopper and sieve.
  • Remove the bottom hopper and gasket by unscrewing the bolts.
  •  Transfer the dismantled parts to the washing area after affixing“TO BE CLEANED”label using SS trolley.               

CLEANING OF MAIN BODY AND AREA:

  • Remove any adhering material to the sifter body using vacuum cleaner.
  • Wipe the body with lint free cloth dipped in Purified water until no adherent material   is seen. 
  • Finally wipe the sifter body with lint free cloth dipped in 70% IPA           
  • Wipe the walls, ceiling, door, and glass with dry lint free cloth and mop the area with  disinfectant solution.

CLEANING OF SIFTER PARTS:

  • Wash the parts with 40L of purified water until no adherent material is visible.
  • Rewash the parts with 25L of purified water.
  • Finally rinse the parts with 15L of purified water
  • Dry the SS parts of the sifter by wiping with cleaned dry lint free cloth.       
  •  Wipe the gasket with lint free cloth dipped in purified water.
  • Finally wipe with 70% IPA.
  •  Transfer the cleaned and dried parts to cleaned processing area after affixing “CLEANED”label.
  •  Assemble the dismantled parts in the reverse order of dismantling.

NOTE:

1. Store the cleaned sieve in the sieve holder placing the sieve in a clean polythene cover/shrink wrapping and label it as “CLEANED” mentioning all the details given in the cleaned label.

  2. Do not store more than one sieve in one polythene cover.

  3. Check the integrity of the sieve before and after cleaning.

FREQUENCY TYPE “C” CLEANING:  

  • Shall be performed between at the product-to-product changeovers.
  •    After continuous production of 6 days of the same product. 
  •   Major break down of equipment.   
  • If the equipment is idle for more than 30 days.

 4.0         ABBREVATIONS

4.1           SS     – Stainless Steel.

4.2           QA   – Quality Assurance.

4.3           QC   – Quality Control.

4.4          IPA   – Isopropyl Alcohol.

5.0        REFERENCES

  • Nil

  6.0       ANNEXURES

 6.1             Nil.

7.0       Distribution

This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing  department.

8.0       SOP Revision History record

Revision No.Details for Revision(s) with Change Control No.Effective Date (Sign. / Date)

For Operation of Vibratory sifter pl refer https://pharmaceuticalupdates.com/2020/10/01/sop-for-vibratory-sifter/

SOP for Vibratory Sifter

1.0       OBJECTIVE

1.1       To describe the procedure for operation of Vibratory Sifter.

2.0       RESPONSIBILITY

  • Technical Assistant – To follow the SOP & operation of sifter.
    • Executive – To verify the operation of sifter
    • Executive – Responsible for compliance of  SOP.

3.0 DEFINITION

Vibratory Sifter is used in Sifting of materials in Pharmaceutical manufacturing with different mesh of Sieves and it is widely used equipment in pharmaceuticals and  in food industries.

Uses of Vibratory Sifter :

Sifting is done to remove  lumps or growth that might have formed on the materials after being stored for a longer period and materials are passed through a mesh that opens, which leads to fine the materials.

It also removes the unrequired foreign particles and separate the materials according to size 

For working principle of sifter Pl. Refer https://pharmaceuticalupdates.com/2020/04/28/working-and-principle-of-vibratory-sifter/

4.0      PROCEDURE

  •   Check the area and machine for cleanliness.
  •  Take line clearance from QA, before starting the operation.
  • Remove the CLEANED” label and affix the “UNDER PROCESS” label to the sifter.
  • Procure all the materials of required quantity as per the BPRR to be sifted in the sifting area.

 NOTE: Sift the materials using specified sieves as mentioned in the Batch record of that product.

  • SET- UP

     FIXING OF THE SIEVE:

  • Check the sieve size for correctness as mentioned in the Batch manufacturing record
  • Check the Sieve integrity before fixing to the sifter.
  • Place the sieve over lower hopper and place upper hopper over it and clamp them with the clamp provided.

FIXING OF LID

  • Place the lid above the upper Hopper.
  • Align the lid from all the sides with respect to hopper.

  OPERATION

  •  Put the power plug into the power supply socket.
  • Switch on/off the mains and ensure that it is working properly and ensure the proper earthing to the sifter or static electricity clamp can be used to avoid static charges.
  • Place SS container/In process Container below the product outlet and the retention chute.
  • Tie one end of the lint free cloth or Silicon bellow to the open end of the discharge chute of the sifter and other end to the container placed below the discharge chute.
  • Place the raw material to be sifted in the IPC and lift the IPC with the help of Material handling device and connect the discharge chute of the IPC to the top of the sifter with dust free interface.
  • Adjust the In process Container (IPC) such that the cone is just inside the charging port provided to the sifter lid.
  • Tie or place silicon bellow to the lid of the sifter and ensure it is aligned properly with discharge of the IPC. 
  • Switch on the sifter and open the butterfly valve of the IPC to regulate the flow of the material to be sifted.

NOTE: In case of unavailability of IPC the raw materials can be kept in SS containers and sifting should be done manually only.

  • After completion of sifting of the material, switch off the sifter and bring down the IPC check for any material remaining in the IPC, if there is any remaining material follow the above step and continue sifting.
  • During sifting retains are collected in double lined polythene bags / IPC through the discharge chute of the sifter on the upper hopper by opening the discharge clamp.
  • Repeat the above procedure for remaining material. After completion of the batch Switch off the mains.
  • Dismantle the sieve and check its integrity and enter the details in the BPRR.
  • Update the status label as “TO BE CLEANED”.
  • Record the operation of the machine in the equipment log book.

5.0 ABBREVATIONS

5.1        IPC      – In process Container.

5.2        BPRR  – Batch Processing Record

5.3        Q.A.     – Quality Assurance

5.4         SS         – Stainless Steel

6.0        REFERENCES

       6.1       Nil

7.0       ANNEXURES

      7.1        Nil

8.0       Distribution

This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing  department.

9.0       SOP Revision History record

Revision No.Details for Revision(s) with Change Control No.Effective Date (Sign. / Date)