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/

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