By: Swaminathan Narayan -- Senior Research Analyst
31 March, 2014
The global market for prefilled syringes is witnessing a heavy spurt in demand due to rising demand for biologics and other potent injectable drugs, technical advances in prefilled syringe manufacturing and packaging, rising demand for self-administration and increasing elderly population suffering from various chronic diseases that require frequent parenteral dosing. Traditionally, glass has been the preferred choice for manufacturing prefilled syringes. However, glass poses certain disadvantages as a raw material, chiefly due to its weight and fragile nature. Moreover, the last few years have witnessed increasing number of recalls of glass prefilled syringes and vials due to delamination issues. Due to the risks, the pharmaceutical industry is considering plastic prefilled syringes as an alternative. This whitepaper analyses the issues with glass prefilled syringes and the extent of mitigation of these issues by the plastic alternatives. Case studies from the industry are examined and the impact on sourcing is discussed as well. Problem Statement Glass prefilled syringes have been for quite a long time because they were viewed as a safe and efficient material to house formulations. However, as more sensitive and biologic based drugs proliferate into the market, the risks associated with glass prefilled syringes are beginning to outweigh its advantages. These risks, namely breakage, delamination, leachables and physical and chemical compatibility can adversely affect the safety and efficacy of the formulation filled in the syringe. In the last 5 years alone there have been more than 20 recalls associated with glass issues, including contamination from delamination (flaking), breakage and particulates, which have resulted in more than 100 million units of drugs packaged in vials or syringes to be withdrawn from the market.
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