SFF

The selection of a container for sterile drug products, particularly biologics, is a critical decision point that greatly influences a drug’s stability, safety, efficacy and its commercial success. The pharmaceutical industry has been developing new, advanced sterile packaging solutions, with innovations like pre-filled syringes (PFS) and blow-fill-seal (BFS) technology offering developers and manufacturers unique advantages that make them suitable for specific applications, potentially extending the suitability of injectable therapeutics to new treatments and patient groups.

Plastic-based solutions, such as BFS, are gaining traction due to their enhanced safety, cost efficiency and design flexibility. BFS technology, in particular, stands out for its integrated aseptic manufacturing process, where containers are formed, filled and sealed in a continuous, closed system. This inherent design significantly reduces the risk of contamination, making it ideal for high-volume sterile products, including vaccines. 

Enhanced product integrity and collaborative expertise

BFS is an advanced aseptic manufacturing process where plastic containers are simultaneously formed, filled with the drug product and then sealed within a single, continuous, highly integrated operation. This closed system minimises human intervention and exposure to the environment, making it ideal for producing sterile liquid-filled products such as injectables with an exceptionally low risk of contamination.  

BFS technology offers a range of critical advantages for sterile drug products, including:

  • Reduced breakage 
    Plastic containers produced via BFS are inherently far less susceptible to breakage compared to traditional glass vials.  
     
  • Economic efficiency at scale 
    BFS technology enables highly efficient, high-volume filling, consistently leading to a notably lower cost per unit compared to traditional aseptic filling methods.  
  • Precision for single-dose applications 
    BFS helps ensure accurate dosing and minimises product waste. 
     
  • Reduced need for preservatives  
    BFS technology often eliminates the need for antimicrobial preservatives, which is beneficial for sensitive formulations. 
     
  • Low extractables and leachables (E&L) profile 
    Thanks to BFS, interaction with the drug product is minimised, enhancing stability and safety. 
     
  • Robust tamper-evident features 
    BFS provides a clear indication of product integrity, enhancing security and patient safety.


Choosing the right container is not merely about material selection but involves a holistic consideration of stability, fill-finish process integrity, regulatory compliance, and supply chain logistics. As the industry moves towards more patient-centric and sustainable solutions, partnering with an experienced contract development and manufacturing organisation (CDMO) like Recipharm becomes invaluable. Their expertise can guide drug developers through early feasibility studies, process optimisation and regulatory pathways, ensuring optimal container selection and successful market entry. 

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