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.

Sampling During Filling:

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