Prefilled syringes are types of injections that use prefilled syringes to dispense medicines. Prefilled syringe is a new type of pharmaceutical packaging material developed in recent years. It is not a medical device, but an integral part of the pharmaceutical packaging system. It has two functions: storing medicine and ordinary injection. Prefilled syringes are mainly used for packaging of vaccines, biological products, biochemical products, anti-thrombotic drugs and other products.

The production of prefilled syringe filling line generally uses ready-to-use prefilled syringes for aseptic filling and stoppering, and uses ready-to-use packaging materials (Ready To Use) for production. The production process mainly includes unpacking outer package, unpacking inner package, filling, stoppering, light inspection, rod rotation, labeling and packaging.

Six Key Points of Prefilled Syringe Filling Line in Production

1. Unpacking Outer Package

The process of unpacking outer package is to transfer the commercially available ready-to-use prefilled syringes to the inside of the prefilled filling machine. The process of unpacking outer package is carried out under the conditions of Class A laminar flow protection, and the sterile nest box syringe is taken out of the outer package. During the entire unpacking process, care must be taken to avoid contamination of the outer bag with microorganisms and particles in the nest box and the environment. Usually, the outer package needs to be manually cleaned, wiped, and disinfected before unpacking to reduce particles and microorganisms on the outer packaging bag.

2. Unpacking Inner Package

The process of unpacking the inner packaging is carried out in a sterile Class A environment. Since particles may be generated when tearing off the film and vacuum transferring the liner, in order to avoid particles entering the syringe, it is necessary to avoid excessive movements to generate particles when tearing off the film and transferring the liner, and make full use of laminar airflow to protect the syringe from being contaminated by particles. Real-time online particle monitoring is performed in this area to assess and control the impact of particles generated during the unpacking production process. In order to reduce the risk of microbial contamination and reduce the manual operation of unpacking inner packaging, a production process of automatic unpacking is selected.

3. Filling and Stoppering of Syringe Filling Line

During the filling process of prefilled syringe filling line, attention should be paid to the aseptic operation of personnel to minimize the interference of personnel operations on the production process. When filling, the filling speed should be controlled to ensure the filling accuracy, and the filling volume should be checked regularly. It is best to use an online weighing system. If an online weighing system is used, the online weighing system needs to be calibrated before production.

During the stoppering process, the rubber plug is greatly squeezed, and the rubber plug is forced out of the casing, and the friction is very large. Therefore, problems such as damage to the rubber plug, generation of particles, and deformation of the sealing line may occur. Therefore, during the debugging and confirmation of casing plugging equipment, the size and roughness of the casing need to be inspected and confirmed to ensure that damage to the rubber plug is reduced during the plugging process, thereby ensuring the sealing of the prefilled syringe and the sterility of the product.

4. Sterilizing

The sterilization of prefilled syringe products is different from other terminal sterilization products. In addition to controlling the temperature and time during sterilization, it is also necessary to control the balance of pressure difference between the inside and outside of the product.
 

5. Blister Packing After Prefilled Syringe Filling Machine

It is necessary to confirm that the prefilled syringe has been installed in the card slot and that the placement direction of the syringe meets the specified requirements.
 

6. Carton Packing

Before packaging, it is necessary to confirm that the batch number, production date, and expiration date information are accurate. QA needs to confirm before printing. During the production process, it is necessary to regularly confirm that the printed information is complete and accurate. If an online monitoring device is used, defective products need to be used to confirm the effectiveness of the online monitoring device before production.

The important focus of the prefilled syringe filling process is "sterile production" and "filling efficiency". Marya can help you achieve a highly efficient aseptic production filling system.