Production

Cleaning, operation, monitoring & Mould change procedure of FFS machine

Shiv Kumar

Cleaning, operation, monitoring & Mould change procedure of FFS machine

PURPOSE: To lay down the procedure of Cleaning, operation, monitoring & Mould change procedure of FFS machine.

SCOPE :  This SOP is applicable for Cleaning, operation, monitoring & Mould change procedure of FFS machine  at WFI manufacturing facility.

REFERENCE(S) & ATTACHMENTS:

References

FFS machine user manual

Attachments

Attachment-I:     FFS Machine Log Book.

RESPONSIBILITY:

Production  Person:

To verify that employees are trained before performing or operation any task relevant to this SOP.

To Maintained the record.

Production Head:

To ensure the compliance of SOP.

Quality Assurance Persons:

To verify that all the instructions are followed properly as per the given SOP.

To ensure implement of the SOP.

Abbreviations

C.C. No. : Change Control Number

WFI :  Water For Injection

FFS : Form Fill Seal

IPA : Iso Propyl Alcohol

BMR : Batch Manufacturing Record

CIP  : Cleaning In Place

SIP   : Sterilization In Place

SFS : Sterile Filter Space

HMI  : Human Machine Interface

PROCEDURE:

Cleaning

Remove previous batch filled units/vials removed from the filling room.

Clean the room wall, floor & drain  as per SOP .

CIP, SIP, filter drying of filters performed as per SOP

Filter integrity of filters perform as per SOP

Clean the outer exposed part of machine, s.s lines, valves with 70% IPA solution & lint free Cloth.

Operation procedure:   

Utility checks:

Check the following utilities before start the FFS:

The mains electrical supply should be 3 phase 380 – 420 v & 50 hz.

Plant steam pressure. it should be  2 – 2.5 kg/cm2.

Oil free & moisture free Compressed air supply should be 6 – 7 kg/cm2.

Cooling water (12 – 18ºC)  pressure should be 2.5 – 3.0 kg/cm2.

Vacuum limit for operation of FFS machine should be of 22 to 26 inch-hg (550-675 mm-hg).

Operation

 Home screen will appear on HMI and enter the user name & password on the HMI and process screen will appear.

Select the programe in production position on HMI & purge the filling nozzles.

Switch “ON” Extruder heating, hydro motor, Extruder Motor, Cooling, vacuum pump, SFS motor, knife heating with HMI of machine.

Check the buffer air & support air pressure on the pressure gauges mounted on machine Adjust the respective pressure as per the requirement.

Then start bulk transfer pump of the manufacturing tank and open the transfer valve.

bulk will transfer to the buffer tank of machine through the 0.22 micron product filter.

Vent the product filter by pressing “vent product filter button”.

Check the temperature of all the 6 zones of extruder, it should be approximate 170-190ºC.

Switch “ON” the screw cooling on HMI.

Fill the S.S granule tank with dispensed Granules & switch “ON” loader motor of FFS Plastic Granules transfer from SS granule tank to granule hopper.

Then granule transfer to the extruder motor.After melting, forms parison in the form of Tubes & come out from the heating cups , discard at least 10 parison cut to until parison Properly forms.

Press the both green colour “cycle start” buttons on the panel & production cycle will start.

Switch “ON” the conveyer belt & cassettes/vials will transfer for further process.

Check the empty weight, thickness, twisting of cassette/vials. all the parameters should be within specification.

Start the filling by pressing “Filling ON” on HMI and adjust the fill volume by Filling time table (5 ml, 10 ml, 20ml, 30 ml etc.) as per BMR

In-process person discard initially 5 cycles and after that withdraw initial sample for Analysis.

Filling will run continuously, & in-process check as per SOP.

After filling complete “switch off” the extruder heating, hydro motor, extruder Motor, Cooling, vacuum pump, SFS motor, knife heating with HMI of machine.

Switch “OFF” the control panel of the FFS machine.

Close the valve of all the utilities.

Post Filling Activity

Ensure that excess lubrication are cleaned.

Mould cleaning & changing Procedure:

Mould Cleaning:

Mould should be clean after any vial spillage or any vials damage in the mould.

Ensure Hydraulic motor is switch off during the mould cleaning.

Mould should be clean with 50-60ºC WFI with lint free cloth followed by IPA 70%.

Mould Change:

During mould change, mould should be in parison position with HMI.

Switch off hydraulic motor and close the mould cooling.

Switch off extruder heating & drain off mould cooling channel.

Remove knife blade and contact pieces.

Remove parison length monitoring sensor & reflector.

Remove all hose pipe of cooling and vacuum connected to the mould.

Remove parison length monitoring sensor and reflector.

Remove parison holder plate of left and right side.

Select programme inching mode.

Select mould (left hand side & right hand side) with the selector switch.

Take mould (left hand side & right hand side ) to close position.

Connect mould change trolley to the respective side mould.

Loose the mould holding bolts and take the mould out of the machine.

Change the mould cavity to their respective size (5 ml, 10 ml, 20 ml, 30 ml).

Check every screw, bolt, O-ring before fixing the new cavity.

Check proper finishing and alignment of mould cavity of both left & right hand side.

Fix both the mould from back side in the machine.

Take the mould into close position and check for proper alignment.

Connect all vacuum and hose pipe back to their position.

Fix all the sensors back to their position.

Open mould cooling & check both side mould for any leakage.

Fix the knife back to his position.

Change tear-off pins plate stand bottom piller to respective size.

Change deflasher punch unit to respective size.

Change machine timer recipe.

After complete the mould change process transfer the previous mold properly mould room.

Clean the filling room and machine properly with disinfectant solution.

Perform CIP and SIP of machine.

Change all the clean area garments and gloves with the sterilized one.

Operation record maintain as per equipment/machine format 

Attachment – I

FFS Machine Log Book

Date /Product Name /Batch No./Filling Volume (Batch Start/End)/Cooling Water (Temp./Press.)/Vacuum Press./Air Press/Buffer Air (Press.)/Hydraulic Oil (Temp./Press.)/Break Down/Cycles