Glass is the most important primary packaging material for injectable drugs, but the demanding requirements of today’s sensitive biologicals mean that we must consider newer, safer alternatives.
Holger Krenz |
Risk mitigation is clearly a big issue for the pharma industry, and companies must go to great lengths to ensure that the necessary tools are in place to manage every potential risk. To this end, we’ve seen countless innovations across the field to ensure that development activities are well documented, that production processes are validated, and that clinical trials are run efficiently. Additionally, we’ve seen greater focus on the patient interface, which has spurred the development of patient-friendly drug delivery devices, such as auto-injectors, pre-filled syringes and ancillary systems.
Despite these innovations, one area of drug packaging has remained more or less unchanged for decades – the packaging for parenterals. Container shelf life plays a very important role in ensuring the stability and reliability of the drug product. The traditional material of choice for primary packaging is borosilicate glass. Glass is a natural product with excellent intrinsic properties; it is inert and virtually gas impermeable. Unfortunately, there are also some drawbacks – glass is fragile, difficult to control within the manufacturing process, and its batch-to-batch quality varies due to the natural source of its ingredients.
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