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 Processing 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 started before filling.
- Ensure that caps of online particle count probes shall be removed and data is recorded.
- Line clearance shall be taken from the IPQA person.
- Records the activity likes; 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 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 filling 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.