Packaging
Glass is typically the most compatible, protective and established primary packaging of choice.
chooses a sulphate buffer,” he says. “But unless you make the wrong choices in your development, glass is typically the most compatible, protective and established primary packaging of choice.” That’s not to say there aren’t any drawbacks, or exceptions. Glass is a fragile material, something that can be mitigated by secondary packaging. It’s also more difficult to produce glass with very tight dimensional control, a factor that must be carefully considered when the primary packaging needs to be integrated with a drug delivery device.
“Unless you make the wrong choices in your development, glass is typically the most compatible, protective and established primary packaging of choice.”
“Glass compounds in primary packaging will be more variable in their dimensions compared to any plastic, so if you have a glass syringe that needs to be combined with a plastic device, the plastic device must be well-designed to compensate for the imprecision that you have with the glass,” Mahler explains. “For this reason, every device manufacturer loves plastic materials on the primary packaging side because it makes the integration easier and a better fit.” With certain formulations – and when glass is exposed to significant heat during terminal sterilisation – delamination can also occur. “This is where the inner surface of the glass container is attacked by the formulation and glass particles
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might get into the product solution over time and make it non-compliant,” Mahler says. The silicone that is required to lubricate glass syringes is also incompatible with a small number of pharmaceutical formulations, although Mahler believes it has received excessive negative attention. Nonetheless, a number of companies are now considering changing their primary containers from glass to plastic for these formulations, so they have lubricant choices other than silicone.
Integrated thinking
A believer in integrated design and holistic thinking, Mahler advises manufacturers to choose the packaging and the formulation of a drug at the same time. “It could be a chicken and egg discussion – do we choose the container because of the formulation or the formulation because of the container,” he says. “But what we do is develop a product from an integrated, design-thinking perspective, developing the formulation and choosing the appropriate primary packaging simultaneously.” After ascertaining what the right container is from a product stability and quality perspective, there are many other parameters to be assessed. This can be as simple as finding a company that can supply the product reliably, in accordance with Good Manufacturing Practices (GMP), and ensuring the production process is reproducible. “Nowadays, with the pandemic making things a little volatile and uncertain, you might want to have a back-up for raw materials, including primary packaging,” Mahler adds. “Do you have the choice of a second source with comparable quality or even identical packaging?” Sponsors also need to think about whether the primary packaging fits the
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