QualityGuidances

1.0       OBJECTIVE:

            To Lay Down the  Procedure for Operation & Cleaning of Eight Head Volumetric Filling Machine.

2.0       SCOPE:

This SOP is applicable for production Department for Operation & Cleaning of  Eight Head Volumetric Filling Machine

3.0       RESPONSIBILITY:

3.1       Officer production & QA personnel shall be responsible for this SOP.

4.0       ACCOUNTABILITY:

4.1       Manager Production & QA Head Shall be accountable for this SOP.

5.0       ATTACHMENTS:

            Not applicable

• PROCEDURE:
  • Operation Procedure:
    • Ensure that the equipment is clean and free from dust.
    • Ensure that the equipment and the area are released by the Quality Assurance department for processing.
    • Connect the electrical supply and check the running of the main machine indicated by an arrow.
    • If the connection is not correct interchange the phase.
    • The interchanging of phase is done by pressing yellow push button. Check the running of the slat conveyor belt from left to right.
    • Select the syringe and fix it at position as per indicated name plate on the cabinet and lock it by top collar and eccentric block lock nut.
    • For increasing the speed, turn the speed knob anti-clockwise direction and for decreasing the speed turn the knob in clockwise direction.
    • Speed of the conveyor belt and filling nozzles stroke must be synchronized.
    • Before starting the machine, ensure that ram bolt nut should be tighten.
    • Fully load the turn table and switch on the slat belt, ensure that stopper no.2 must be outside. As the slat belt get completely loaded, press the ‘ON’ push button of main machine.
    • The pipe should be tightly fitted to the filling tank to avoid passing air bubbles to the filling
    • The bottles will the displaced from the filling area to the sealing area through the conveyor automatically.
    • The cap hopper should be filled with the PP caps manually and the bottles will get sealed by the screw capping machine.
    • Check the bottles for any air bubbles and particles etc. during filling stage at the bottle inspection  area
    • Check any leakage of the liquid during operation.
    • After completion of the operation, switch ‘OFF’ the power supply of the machine & main power supply.
    • Affix “To be cleaned” status label on the Machine after completion of the batch.
    • Record the operating data in the Machine Operation log register.
  • Cleaning Procedure:
    • Type ‘ A’ Cleaning procedure.
    • Switch “OFF” the machine & main power supply.
    • Fill the holding tank with demineralized water, circulate for ten minutes and Drain. Give two more rinses.
    • Disassemble the nozzles, piston, tubing’s and washer, Clean all the tubings and syringes, first passing continuously with water and wipe them with a clean dry lint free cloth.
    • Put the dismantled parts in clean polybag insert the duly filled and signed“To Be cleaned” label between the first and second polybag.
    • Transfer the polybag to the washing area and clean the parts with potable water till the previous product residue is completely removed.
    • Clean the parts with 0.1% w/v sodium lauryl sulphate solution followed by potable water till the traces of cleaning agent is not completely removed
    • Finally clean all the parts with purified water.
    • Affix a ‘CLEANED’ label on the machine with the details of the previous
    • Type ‘B’ Cleaning: (In case Of Batch To Batch Change over)
    • Switch “OFF” the machine & main power supply.
    • Clean the nozzles, piston, washer and tubings with dry Lint free cloth. Finally wipe all the contact parts with 70% IPA with the help of lint free cloth.
    • Affix a `CLEANED’ label on the machine with the details of the previous product used.
  • TROUBLE SHOOTING AND MAINTENANCE

•  REFERENCES:

In-house

8.0      ABBREVIATIONS

SOP         –    Standard Operating Procedure

IPA          –     Iso Propyl Alcohol

P.P.Caps  –     Poly Proplyene Caps

9.0      DISTRIBUTION LIST:

           Quality Assurance

Production

10.0     HISTORY OF REVISION:

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