Abstract
Ready-to-use (RTU) sterile syringes account for approximately 80% of the global consumption of these primary containers. The remaining 20% are bulk ones which still need to be washed, siliconized, assembled and sterilized before they can be processed on a fill and finish line. Although there are still firms sourcing the latter, there is a clear trend toward switching to RTU syringes and, therefore, outsourcing operations to primary packaging suppliers.
There are several reasons why these activities are contracted to external partners. When comparing RTU primary packaging to traditional bulk containers, the advantages are clear: lower investment costs and smaller footprint equipment for fill and finish upstream processes such as syringe washing, drying, siliconization and assembly. They can also reduce the complexity of the overall process which, in turn, yields superior quality performances. All of this enables organizations to focus and deploy resources on their core business activity: developing and manufacturing innovative, safe and effective drug products to treat patients.
With this outsourcing trend comes a growing reliance on primary packaging suppliers to address increasingly stringent regulations for safer drug products. Since 2006, nearly 50 medications have had glass breakage or particulate issues serious enough for FDA recalls, impacting over 100 million units of mediation. While the risk to human health is paramount, glass particulates contribute to other global healthcare issues like drug shortages. The formulation of parental drugs is highly demanding and complex. It is crucial to guarantee the sterility of the product and the container closure integrity (CCI) at every step. To comply with the expectations of companies and regulators, manufacturers must invest in state-of-the-art production and inspection technologies, which enable the fulfilment of such high-end requirements. Like with other obstacles, there is almost always a way to overcome it. Perhaps laser-assisted cutting technology system, which leads to the improvement of final products' dimensional accuracy, mechanical property and/or reduction of glass particles, is the answer.
