Filling method of drug pre-filled syringe aseptic filling process

2024-06-24

original

Marya

According to the different filling methods of products, pre-filled syringe filling is divided into three types: ordinary filling, nitrogen filling and vacuum filling.

Protein-based therapeutics have become a major driver of growth in the pharmaceutical industry, and the drug development pipeline is flooded with related biologics. Because these large and complex molecules are extremely unstable, they face great challenges in the production process. Filling of aseptic preparations is particularly critical as the last link throughout the drug development and clinical treatment production stages.

According to the different filling methods of products, pre-filled syringe filling is divided into three types: ordinary filling, nitrogen filling and vacuum filling. Professional MV service providers will choose different filling methods according to the needs of products and customers.

1. Ordinary filling

The filling process does not require vacuum and inflation, and the liquid medicine is directly filled into the syringe and then plugged. The disadvantage of ordinary filling of prefilled syringes is that there are air bubbles in the syringe, which is not easy to plug, so you can choose the sleeve plug method when filling. The method is suitable for the production of most solution-type injections and vaccines, and is suitable for high-speed filling with high speed.

A. Needle down B. Liquid filling position C. Liquid filling stop position D. Needle continues to rise E. Highest position
Figure 1 Ordinary filling process

2. Nitrogen filling

Products sensitive to oxygen can choose a nitrogen filling protection device. According to the different nitrogen filling time, there are three methods: simultaneous nitrogen filling for filling hollow tubes, supplementary nitrogen filling between filling and plugging, and nitrogen filling for plug sleeves. It can ensure that the whole process of liquid medicine filling and plugging is completed under the protection of nitrogen, so as to ensure that the residual oxygen in the medicine is low.

The filling process is shown in Figure 2. The needle starts to drop from the original position D, starts to add nitrogen at the position in Figure A, and continues to drop to the lowest position in Figure B. The needle starts to add liquid and rises slowly. When it rises to the position in Figure C, stop adding liquid, nitrogen filling stops, the needle continues to rise to the highest position in Figure D, the entire filling action is completed, and the needle enters the next syringe filling cycle.

A． Nitrogen filling start position B. Nitrogen filling start liquid filling position C. Liquid filling stop position D. Highest position
Figure 2 Nitrogen filling process

3. Vacuum filling

Vacuum filling can be used when the product has high viscosity or is sensitive to air. Vacuum the syringe before adding liquid, fill the syringe with nitrogen and release it after adding liquid, transfer the syringe to the stoppering station, press the stopper after vacuuming, and then carry out nitrogen-filled release after the stoppering is completed. The appearance of vacuum filled products has little or no bubbles.

The filling process is shown in Figure 3. The needle starts to drop from the original position E, and starts vacuuming when it drops to the position in Figure A, and continues to drop to the lowest position in Figure B. The needle starts to add liquid and rises slowly, rises to the position in Figure C, and stops adding liquid, the needle continues to rise to the position in Figure D, the vacuum stops, the pipe is replaced with nitrogen, and the nitrogen stops after a certain period of time, the needle rises to the highest position in Figure E, the entire vacuum filling action is completed, and the needle enters the next syringe filling cycle.

A. Vacuum start position B. Filling start position C. Filling stop position D. Vacuum off position E. Highest position
Figure 3 Vacuum filling process

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Causes and solutions of vials broken in freeze-dried