VIALS FILLING MACHINE AND STOPPERING M/C.

OPERATION OF VIALS FILLING MACHINE AND STOPPERING M/C.

Precautions and Instructions:

• Ensure about the availability of adequate pressure of required gases (LPG, Oxygen and Nitrogen etc.,) at user point through central gas supply.

  

  VIALS FILLING MACHINE

• Ensure about the cleaning and sanitation of room and machine shall carry out satisfactorily.
• Ensure about the line clearance procedure has been followed.  There shall not be any left over of the previous batch filled and sealed Ampoule/vials in the machine.
• Ensure about the personal hygiene and cleanliness while working on the machine.
• Only released sterilized vessel, Equipments, accessories also the released washed and sterilized ampoules to be used.
• All operations to be carried out by wearing presterilised surgical hand gloves on which periodical spray of 70% solution of IPA shall be taken during whole operation.
• Filling and sealing of ampoules including the assembling of all accessories to be carried out under laminar air flow station, lighted ‘ON’ at least 30 minutes before operation start.

  

  VIALS FILLING MACHINE

Operation

• Switch ‘ON’ the LAF at least 30 minutes before the actual operation start including the assembling of the accessories.
• Ensure about the stage label of sterilized silicon tubing, SS syringes, needles and other accessories and bring them to working station from cooling zone.  Simultaneously, bring the filling vessel containing filtered solution from filtration room as a whole quantity (Total lot/lots).
• Connect the outlet of both deep tubes of filling vessel to the inlet of each set of manifold, the three outlets of later are being connected to the inlet of three pre-sterilized SS syringes having non-return valve. Connect the three outlets of other set of manifold to the inlet of other three pre-sterilized SS syringes having non-return valve.  Connect the outlets of these all six syringes to the inlet of six SS needles having non-return valve in each.
• Connect the outlet of air vent to the sterilized vent filter of 0.2 micron.  Keep all six filling needles in cleaned sterilized SS jar and suck the solution by punching the piston of SS syringes to make the whole assembly free from any air bubble and leakages. 
• Fix up the grip of piston in the clamp of volume adjustment device.
• Adjust the filling volume with the help of adjustment device provided by giving initial run to the machine for each and every syringe by taking stroke directly in the measuring cylinder. 
• Keep some empty ampoules on moving rack and take the whole socket of machine down and alignment of all six needles to be done in such a way so that during filling all those will be inserted in the middle of the stem of empty ampoule.
• Now, take the whole socket of machine up and all burners to be lighted on.  Intensity of the burner flame to be set with the adequate pressure of LPG and Oxygen individually.
• Now, switch ‘ON’ the machine, check the filled volume of all six ampoules and their proper sealing, if required adjust accordingly.  Discard some ampoules, which are being filled at initial stage.
• If quality of sealing of ampoules is found OK then run the machine continuously by feeding empty ampoules in the hopper with the help of SS loading tray and at the same time collect the filled and sealed ampoules collected at other end in ampoule collecting tray. 
• Discard the solution which is collected in jar for volume adjustment.
• Carry out the periodical in-process check. 
• After completion of the operation, switch ‘OFF’ the machine and transfer whole lot of filled and sealed ampoules to the loading side of the autoclave from where they shall be loaded in MHS for terminal sterilization if required or leak testing.