SFF
Pre-filled syringes (PFS) are an increasingly popular method for administering injectable drug product formulations, offering many advantages such as improved dose accuracy, ease of use, and reduced risk for patients.
The use of PFS is expected to continue growing in the coming years, with the international PFS market projected to reach $6.5 billion by 2030, up from $3.6 billion in 2021.
But, harnessing the benefits of PFSs poses challenges to drug manufacturers, particularly when it comes to the processing and packaging stages of pharmaceutical commercial manufacturing.
Companies must be aware of the complexities and consider key factors for a successful PFS production, which include:
Aseptic processing:
Aseptic processing is an essential process for maintaining sterility throughout the manufacturing process of a parenteral therapeutic and must be done in an aseptic and contained environment and comply with regulations like the EU’s Annex 1 of the GMP.
This process must be carried out in cleanroom facilities with advanced aseptic controls to prevent contamination. Strict environmental controls, cleaning and validation regimes performed across these processes are key to reducing the risk of contamination of drug products.
Secondary packaging:
Needles for these injectables are fragile, therefore requiring careful handling and strong secondary packaging. Some PFSs are packaged as part of a kit (a process called kitting), containing a separate needle, a safety device such as a finger flange or backstop, alcohol pads and information leaflets.
The contents of the kit may vary from one drug product to another, or they may vary according to the requirements of the markets the product batches are destined for.
Ensuring compliant labelling
Labelling must be compliant with local regulations and languages across many global markets. This information must be displayed clearly to ensure that patients can understand them and know exactly what they are taking.
Meeting regulatory requirements in transit
The transit of PFS devices requires suitable cold-chain supply and temperature control from factory to administration. More and more key markets are introducing stringent serialisation regulations to optimise the traceability of all drug products, including those packaged in PFS forms. This is a key consideration for manufacturers when developing logistics solutions to ensure they achieve regulatory compliance.
In a recent piece with IBI Magazine, Robert Fielders, Director, Engineering at Recipharm, examines these benefits of PFS further and provides his insight on how to overcome common challenges associated with PFS filling and packaging.
The article can be found on pages 26-27.