SFF
The pandemic has been a key driver for this growth, with greater consideration now given to the use of pre-filled syringes to speed up the administration of vaccine programs in the future. Additionally, pre-filled syringes are also being considered for a wider range of biologics, such as cancer and autoimmune treatments, as they allow patients to self-administer their own medicines.
However, there are a number of considerations that companies should be aware of if they want to harness pre-filled syringes, particularly when it comes to filling. Some of these include:
- The importance of sterile fill-finish: Due to the fact these therapies bypass the body’s principal defence systems in the GI tract, these therapies require strict adherence to sterile processing to ensure they are safe for patients. Their manufacture requires strict protocols across cleanroom facilities, with production lines featuring restricted access barrier systems (RABs) and/or other advanced aseptic processing controls.
- Employee safety and cross-contamination protocols need to be in place: If a therapy contains highly potent active pharmaceutical ingredients (HPAPIs) or a biologic active ingredient, manufacturers must implement additional safeguards to manage toxicity risks that prevent exposure to operators or cross-contamination of other products.
- Ensuring traceability: An increasing number of regulatory authorities around the world require the traceability of pre-filled syringe and other drug products as they move from the production line to the end patient to ensure that counterfeit products are prevented from entering the pharmaceutical supply chain.
Overcoming these challenges to meet the needs of pre-filled syringe products is a pressing issue for manufacturers to achieve, particularly those doing so for the first time.
In our latest piece with IPI Magazine, our site manager Michael Isele explores these pitfalls of filling and packaging in pre-filled syringe formats, from sterile integrity requirements, to packaging challenges, such as kitting, and explains how these challenges can be addressed.