SFF

The pharmaceutical industry has witnessed a growing demand for efficient and easy-to-use drug delivery devices offering the efficient and accurate delivery of a variety of drug products in the past five years. Pre-filled syringes (PFS) represent a revolution in medication administration. Delivered to the patient already charged with a single dose of therapy, these innovative delivery systems offer a wide range of advantages for both patients and drug developers: 

  • Significantly reduced risks of dosage inaccuracies  
  • Minimised product waste compared with multi-dose alternatives 
  • Improved patient accessibility with user-friendly design, easing self-administration 
  • Streamlined administration, saving healthcare professionals’ time 
  • Minimised contamination risks with single-use nature. 

These advantages make PFS an ideal choice for biologic treatments, especially for high-cost medications, where minimising waste equates to significant economic and environmental benefits. Simplified administration also makes PFS a strong delivery system candidate in fast-paced clinical settings.  
 

Pre-filled syringe filling challenges 

Despite the many benefits PFS can provide, realising its potential as a delivery system can be difficult, owing to its small size and complex design as well as the need to maintain sterility and minimise variability in filling. Challenges can include: 

  • Preventing air entrapment within syringes, which can impact dose accuracy and integrity 
  • Guaranteeing product sterility and integrity to safeguard patients’ health 
  • Ensuring compatibility between the drug formulation and syringe material 
  • Navigating the stringent and evolving regulatory landscape 
  • Maintaining formulation stability and enhancing shelf life. 

Surmounting these hurdles can be time-consuming and relies on a comprehensive understanding of PFS technology, innovative manufacturing systems and stringent quality control measures.  
 

Strategies for overcoming pre-filled syringe hurdles 

Engaging with a contract development and manufacturing organisation (CDMO) specialised in sterile fill-finish and prefilled syringe services offers pharmaceutical companies access to the extensive knowledge and expertise in aseptic manufacturing needed to support PFS projects.  

Read our recent article to find out how Recipharm’s proactive approach to PFS filling, supported by effective communication, comprehensive filling capabilities and a track record in regulatory excellence can help overcome complexity.  
 
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