Filling Procedure for vaccine in Pharmaceutical

The procedure is applicable to the general procedure for filling the vaccine in the manufacturing area.

Preparation of Primary packaging material for filling:

  • Receive the primary packaging material from the store as per the requisition slip.
  • Transfer the rubber stopper and seals to the material preparation area for sterilization.
  • Transfer the glass vials to the box-cutting area and Process of rubber stoppers.
  • process the aluminum seal and De-cartoning of glass vials followed by Washing of glass vials and Depyrogenation of glass vials.

Preparation of Filling Machine parts :

Note: If required take the change over to the required format size 2ml, 3ml, or 5 ml format.
Wash and prepare filling machine accessories and pack the required size of Piston’s needles and manifold as per the fill volume requirement.

Check Points Before Filling:

  • Before the start of the operation check for a complete changeover of the machine parts and their fixation.
  • Recirculation of product from the machine product tank to the formulation vessel shall be required in case of Gel-based batches and in clear solution-based batches this recirculation is not required.
  • Physically check the sterilization status of filling machine parts, stoppers, and seals.
  • Before starting filling activities ensure that LAF shall be in operation before 30 minutes.
  • Check and record the differential pressure of the filling room and filling LAF.
  • Ensure that environmental monitoring activities in the filling area start before filling.
  • Ensure that caps of online particle count probes are removed and data is recorded.
  • Line clearance shall be taken from the IPQA person.
  • Records the activity like; filling, record the temperature, relative humidity, room pressure, and differential pressure of LAF as per given frequency.

Procedure for filling:

  • Take the line clearance from the IPQA person.
  • Aseptically fix the filling machine parts, In case of gel-based batches connect the recirculation connections for recirculation of product from the machine product tank to the formulation vessel.
  • Recirculation of the product shall be done with a peristaltic pump having reset parameters
  • Aseptically transfer the sterilized rubber stoppers into the stopper hopper.
  • Check all the parameters required for the operation of HMI
  • Start the batch on the filling machine
  • Calibrate the IPC weighing module and check the printout.
  • Then start the priming process of filling needles for removal of air from filling needles.
  • Collect the priming volume in the “Priming collector”.
  • Aseptically transfer the Priming volume into the Nalgene bottle and send it to QC for sterility testing.
  • For small batch sizes, the priming shall be done directly into glass vials which shall be sent to QC for sterility testing.
  • Start the filling of the vaccine in vials.
  • The filled & stoppered vials are sealed with an aluminum seal.
  • Transfer the sealed vials to the cold room till visual/Automatic Inspection, labeling & packing.
  • After completion of filling stop the batch and aseptically collect the leftover bulk in a sterile Nalgene bottle for sterility testing.
  • Decontaminate the rejected vials during the filling.
  • Transfer the leftover sterilized material (stopper and seal) to the decontamination area.
  • Decontaminate the opened or intact sterilized rubber stopper bags.
  • Remove the machine parts and send for decontamination.
  • Clean the machine with 70 % IPA and fill the area as per the area cleaning process.
Flow chart for Filling Procedure for vaccine

Sampling During Filling:

Collect the priming sample aseptically and send it to QC for sterility testing as per the sampling plan.

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