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Vibro Sifter – Procedure for Cleaning and Operation

Standard Operating Procedure for Cleaning and Operation of Vibro Sifter. Pharmaceutical Vibro Sifter is used to separate mass composition of solids, liquid from solid and grading the material as per particles size. It is a type of pharmaceutical machine used for separation of pharmaceutical solids or liquids.

Vibro Sifter – Operation & Cleaning

1.0   Objective

    • To lay down the procedure for cleaning & operation of vibro sifter.

2.0   Scope

    • This SOP is applicable for cleaning & operation of vibro sifter used in the granulation section of tablet manufacturing plant.

3.0   Procedure

    • Product change over (Type A):

    • Change the status of area and ensure that area is displaying the current status along with sign & date of respective personnel.
    • Use the High Pressure Water Jet cleaning Machine for cleaning of Vibro sifter as per the instruction given in SOP.
    • Pressure adjustment shall be done during performing the cleaning activity with High Pressure Water Jet cleaning Machine.
    • Before performing cleaning operation of Vibro sifter, ensure that AHU of the respective area shall be “OFF”.
  • Cleaning of Vibro sifter

    • Switch ‘’OFF’’ the MAINS.
    • Dismantle the holding ring and remove the hopper, gaskets and other accessories.
    • Clean the hopper, gaskets, and other accessories with using nylon scrubber dipped in potable water to remove the traces of previous product.
    • Clean the external surface of Vibro sifter with High Pressure Water Jet cleaning Machine.
    • Rinse all the parts with purified water.
    • Visually check the cleanliness of hopper, gaskets, external surface of Vibro sifter and other accessories.
    • If cleanliness is found satisfactory proceed for further activity otherwise repeat the steps.
  • Cleaning of Sieve (Vibro Shifter)

    • Take used sieve / screen to adjacent wash room, in case where wash room facility is not available then pack in a poly bag and transfer it to wash room area for cleaning.
    • Wash the sieve / screen with potable water to remove adhered powder. Clean the sieves / screens using high pressure water jet cleaning machine by adjusting the pressure using potable water.
    • Operate the high pressure water jet cleaning machine as per SOP .
    • Dry the sieve / screen with compressed air by applying low pressure.
    • Check the cleanliness and integrity of dried sieves / screens, if cleaning is not satisfactory re-clean the sieve / screen.
    • If cleanliness is found satisfactory proceed for further activity otherwise repeat the steps.
    • Take the cleaned, dry, inspected sieves / screens to the “Sieves / Screens Storage area”, make entry in issuance, usage, cleaning and retrieval record of sieve / screens.
    • After that dry the hopper, gaskets, sieve, external surface of Vibro sifter and other accessories with compressed air or by mopping with dry lint free cloths.
    • Fix the ring & hopper on sifter body.
    • Cover the opening with clean poly bag.
    • Clean the area as per SOP.
    • Then inform QA chemist to take the swab sample from Hopper ring, hopper sieve, and holding ring and discharge port.
    • Send to QC for testing along with the filled “Swab Test Intimation slip / Analysis Report”.

Related : Swab Test – Sampling and Analysis

    • After analysis QC chemist shall enter the details in “Swab Test Slip / Analysis Report” and send back to Production.
    • On satisfactory report, affix duly filled and signed status label as per SOP.
    • Report if not satisfactory then repeat the steps.
    • Affix dully filled and signed status label as per SOP.
    • Enter the details.
    • Validity: 72 Hours.
    • After validity period, Type A cleaning shall be performed, before start of next activity and QC release is not required.
    • Keep the clean sieve in fresh polybag when it is not in use with proper status label.
    • Batch change over (Type B):

    • Change the status of area & Equipment.
    • Clean the outer and inner surface of vibro sifter by moping with clean lint free cloth.
    • Clean the sieve by using compressed air.
    • If the processing of next batch takes more than 48 hours then clean the equipment following (Type A cleaning).
    • Enter the details in Equipment Log.
  • Operation of Vibro Shifter :

    • Ensure the cleanliness of Vibro Sifter and status label affixed on the Sifter.
    • Ensure that the proper working of HVAC system by checking the pressure differential of area & temperature and RH.

Also read : Operation and Cleaning of RMG

    • Get the line clearance from QA chemist before starting the operation.
    • Fit the required sieve in the vibro sifter as per specified in the BMR.
    • Place IPC / container lined with double polythene bag below the outlet of sifter & tightly hold the polybag with sifter to avoid any spillage of the material.
    • Switch ‘’ON’’ the MAINS.
    • Start the process.
    • After completion of work switch ‘’OFF’’ the MAINS.
    • After completion of activity change the status of area and affix dully filled and signed status label on the Vibro Sifter as per SOP.
    • Enter the details in BMR.

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