Pre-filled syringes have long played a major role in the injectable drugs market. Yet, while this increasingly popular type of product can meet patient needs effectively, it also creates a wide range of challenges for pharmaceutical companies. 

 

What are pre-filled syringes?

Pre-filled syringes are single-use syringes that contain a certain pre-dosed amount of medication, so they are ready for use. 

These products are used extensively:

  • when working in areas where high standards of hygiene cannot be guaranteed 
  • for emergencies or situations outside a hospital setting
  • when the injection needs to be given by untrained personnel (or by patients themselves) 
  • in all cases where it is more convenient to use a single device instead of the traditional combination of a syringe and a vial containing the injectable product.

Pre-filled syringes also offer increased safety. A pre-dosed product that is ready for use minimizes dosing errors and the risk of contamination (inevitable when a needle needs to be used to aspirate a liquid from a glass vial). It also leads to savings of raw material since injectable vials generally contain more of a drug than is required for use. Using a pre-filled device minimizes this risk, limits waste and cuts costs.

Pre-filled syringes are now used widely in many medical fields because of their convenience, efficiency, and safety for patients. Today, vaccines and a wide variety of other drugs are commonly provided in pre-filled syringes, which are gradually replacing traditional syringes in an increasing number of applications.

 

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Leak testing Pre-filled Syringes: Challenges and peculiarities

The popularity of pre-filled syringes and the many advantages they offer patients have led pharmaceutical companies to invest in this specific type of product. Today, the materials used and the filling techniques (essential to ensure the syringe is properly sterilized before it is filled) are extremely advanced, and the industry continues to evolve and be the focus of research.

However, in this sector, it is not sufficient to provide the patient with products that are easy to use, safe and made of state-of-the-art materials. Reliable, efficient product control systems are also essential to ensure patient safety by confirming that:

  • the syringe has not been damaged or scratched, or punctured, which could cause drug leakage or contamination
  • the plunger was not moved during the syringe filling process, and that the amount of liquid contained within the barrel is exactly as expected

 

Bonfiglioli Engineering Solutions for pre-filled syringe leak testing

Bonfiglioli Engineering machines use the Vacuum Decay Method (VDM) to test pre-filled syringes. This test is proven to be non-invasive, non-destructive while being accurate and effective in identifying leaks in packaging and products not complying with quality standards. Every syringe can be tested without risk of contamination or product loss.

VDM tests 100% of production quickly, making it particularly suitable for testing products of this type. Because injecting a contaminated drug or a dosage error of an injectable product can have very serious repercussions on patient health, it is essential that the integrity of every single syringe be checked, ensuring it is intact and has no leaks or micro-holes, before it is made available for sale. 

Another advantage offered by VDM is its great flexibility. Extremely small test chambers designed according to the dimensions and shape of the product to be tested can be used, minimizing the time required for testing and providing fast and accurate results.

Bonfiglioli Engineering devotes a great deal of attention to the development of customized handling solutions that ensure that syringes are moved without their piston being touched, to avoid product loss.

For more information about Bonfiglioli Engineering pre-filled syringe testing equipment and to learn more about the potential and features of our models, download the attached Application Note.

 

We are not just a machine manufacturer. We are your trusted partner for packaging integrity testing and analysis through feasibility studies, technical expertise, validation packages, product handling and custom-built solutions.

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