The necessity of inert gas during the filling of pre filled syringes&Shanghai Yaoshun Machinery's nitrogen filling solution

In pre filled syringes（The use of inert gas (nitrogen) during the PFS filling process is crucial for the stability, safety, and filling accuracy of the drug. The following is the necessity and Shanghai Yaoshun Machinery (Shanghai)ALWELLAdaptation plan for Machinery related equipment:

---

The necessity of inert gas (nitrogen) in filling

（1) Prevent drug oxidation and degradation

·Biological drugs (such as monoclonal antibodies, vaccines, peptides) are easily oxidized by oxygen, leading to reduced efficacy or the production of harmful impurities.

·Replacing oxygen with nitrogen can extend the shelf life of drugs.

（2) Avoid microbial contamination

·During fillingtopministryResidual air may breed microorganisms, while nitrogen filling can inhibit bacterial growth.

（3) Improve filling accuracy

·Reduce bubble interference and ensure accurate dosage (especially for high-value drugs).

（4) Prevent protein aggregation

·Biological agents in gas-Liquid interfaces are prone to aggregation, and nitrogen protection can reduce interface reactions.

---

2. Shanghai Yaoshun Machinery's nitrogen filling solution

Shanghai Yaoshun Machinery（ALWELLMachinery providesPre filled syringe filling production line, adaptable Nitrogen protection system, applicable to:

·Biological drugs (vaccines, monoclonal antibodies, insulin, etc.)

·High value-added injections (tumor drugs, gene therapy products)

·Easily oxidizable chemical drugs

（1) Nitrogen protection method

·Nitrogen flushing before fillingReplace the air inside the syringe to create an inert environment.

·Headspace nitrogen fillingAfter filling, inject nitrogen and seal to reduce oxygen residue.

·Fully enclosed filling systemFull process nitrogen protection, suitable for highly sensitive drugs.

（2) Equipment features

✅High precision filling：± 1% filling accuracy, suitable for 0.5mL~20mL specifications.
✅GMP complianceSuitable for aseptic filling.
✅modular designCan integrate functions such as nitrogen system and vacuum deoxygenation.
✅Automation control：PLC control, adjustable parameters (nitrogen flow rate, pressure, etc.).

---

3. Applicable industries and cases

·biopharmaceutical(Monoclonal antibodies, vaccines, cell therapy)

·Chemical injection(Tumor drugs, contrast agents)

·medical aesthetics industry(Hyaluronic acid, collagen filler)

---

4. Conclusion

✅Inert gas (nitrogen)In pre filled syringe filling, especially forHighly oxidizable and valuable drugs.
✅Shanghai Yaoshun MachineryprovideNitrogen protection filling equipmentSatisfy High precision, sterile, compliantrequirement