Prefilled needle production process

The production of prefilled needles generally uses ready-to-use prefilled syringes for aseptic filling and stuffing, and ready-to-use packaging materials for production. The production process mainly includes outsourcing, internal packaging, filling, stuffing, lamp inspection, rotating rod, labeling and packaging.

The common production process of prefilled needle is as follows

Key process control points of each process

1. Outsourcing

The process of outsourcing is to transfer commercially available ready-use prefilled syringes to the inside of the filling machine. The process is conducted under the condition of A-level laminar flow protection, taking sterile cartridting syringes out of their outer packaging. In the whole process, we should pay attention to avoiding the external bag's pollution to the nest boxes and environment's microbes and particles. It is usually necessary to manually clean, wipe and disinfect the external packaging before unpacking to reduce the particles and microorganisms on the outer packaging.

2. Remove the inner package

The process of removing the inner package is carried out in A sterile grade A environment. Since particles may be generated during film tearing and vacuum transfer of the liner, in order to avoid particles entering the syringe, it is necessary to avoid particles generated by excessive motion amplitude during film tearing and transfer of the liner, and make full use of laminar airflow to protect the syringe from particle contamination. Real-time on-line particle monitoring is conducted in this area to assess and control the impact of particles generated during the unsourcing process. In order to reduce the risk of microbial contamination and reduce the manual operation of unpacking inner packaging, the production process of automatic unpacking is selected.

3. Filling and stuffing

In the filling process, attention should be paid to the aseptic operation of personnel, and the interference of personnel operation on the production process should be reduced as far as possible. When filling, the filling speed should be controlled to ensure the accuracy of filling, and the filling quantity should be tested regularly. It is best to use online weighing system. If online weighing system is used, it is necessary to calibrate the online weighing system before production. In the plugging process, there is a lot of extrusion of the rubber plug, and the rubber plug is forced out of the casing, which is subjected to a lot of friction, so the rubber plug may be damaged, particles and sealing line deformation, etc. Therefore, in the debugging and confirmation of the casing plugging equipment, the size and roughness of the casing should be checked and confirmed to ensure that the damage to the rubber plug is reduced during the plugging process. To ensure the sealing of the prefilled syringe and the sterility of the product.

Step 4 Sterilize

The sterilization of pre-filled needle products is different from other final sterilization products. In addition to controlling the temperature and time during sterilization, it is also necessary to control the balance of internal and external pressure difference of products.

5. Light inspection

If it is artificial light inspection, before light inspection, it is necessary to confirm the illumination of the lamp inspection machine to ensure that it can meet the needs of lamp inspection. If the lamp inspection machine is used, before the lamp inspection, in addition to confirming that the parameters of the equipment meet the process requirements, defects should also be used to confirm the lamp inspection machine before use.

6. Add putters and stickers

The number of torque turns or strength of the rod rotation process needs to be confirmed. Considering that excessive rod rotation may affect the displacement of the pre-filled needle tube and the rubber plug, resulting in abnormal sealing and thus affecting the sterility of the product, the challenge of rod rotation process also needs to be considered when simulating the filling of the medium.

7. Blister wrap

Ensure that the prefilled syringe is installed in the card slot and placed in the direction required.

8. Box it

Before packing, it is necessary to confirm the accuracy of batch number, production date and expiry date. QA is required to confirm before printing. During the production process, it is necessary to periodically confirm the completeness and accuracy of printing information. If an online monitoring device is used, defective products should be used before production to confirm the effectiveness of the online monitoring device.