A Need for Higher Quality Packaging
Over the past several decades the biopharmaceutical industry has produced an impressive array of advances — new biological drugs for treating previously intractable diseases, high-speed filling lines to improve the availability and access of essential medicines for patients around the globe, and innovative new drug delivery systems that reduce errors and enhance patient compliance. At the same time, the standards for quality and safety have continued to rise steadily, driven by the same societal factors that affect other industries. These advances have put additional demands on the glass material used for drug storage and delivery.
Ironically, while the pharmaceutical industry has driven innovation in drug discovery and development, the glass containers in which medicines are housed have remained largely unchanged. Pharmaceutical manufacturers invest significant resources and time taking molecules from bench to bedside while the glass containers that store these life-saving products is largely dependent upon science originating from the 1930s (1).
Regulatory bodies and pharmaceutical manufacturers alike began to take notice of failures associated with current glass containers in 2011 when the U.S. Food and Drug Administration issued an advisory highlighting the risk of glass lamellae occurring in certain injectable drugs (2) due to a phenomenon known as delamination. Since then, glass packaging-associated recalls caused by delamination, glass particulates, and cracked containers that threaten drug product sterility have continued to plague the industry.
Drug recalls—and the associated risk of product shortages— are not the only challenges pharmaceutical manufacturers have faced. Concurrently, a longtime partner of Corning’s approached the company seeking a robust pharmaceutical glass that could survive high-speed fill and finish manufacturing. It became clear there was an industry need for a higher quality pharmaceutical glass packaging.
A Remarkable Glass Package
Corning Incorporated, a company with a 167-year history, has a long track record of partnering with industry leaders to solve difficult problems. The challenges of glass packaging drew widespread attention to the issues with conventional containers. Researchers at Corning also noticed and began to investigate the cause of the issues.
Corning identified boron as the root-cause for delamination (3) and engineered a boron-free composition called Corning Valor® Glass (4). Valor Glass is specifically designed for pharmaceutical use. It can be converted using traditional techniques without the risk of delamination.
While boron, a volatile element, is the root cause for delamination – the converting process also impacts a container’s chemical durability. During the converting process, specifically the step where the glass cane is parted (or separated) into two containers, the flame releases the boron from the glass network. Boron-containing compounds move around and evaporate as gas out of the glass network largely in the heel region of the vial.
Like a charged helium balloon sticks to a wall or object, the boron particles adhere to cool regions in the side-walls and heel (bottom) of the vial. A composition already rich in boron is now converted into its final format, with deposits that are richer in boron and sodium than the intended composition. This alters the glass chemistry of the container’s drug-contact surface. These areas rich in sodium borate, are vulnerable to delamination and ultimately pose risk to pharmaceutical product quality.
A Glass Designed for Pharmaceutical Use
Although glass is the ideal material for pharmaceutical containers, it is well-known to have some chemical interactions with drug products, especially over long periods of time. The industry assesses extractables and leachables concentrations of a container during stability studies, prior to introducing a drug to the market (5). Manufacturers monitor the profile and concentrations of extracted elements (e.g. boron, sodium) from the glass container during accelerated or shelf-life conditions. Differences in concentrations of extractables from glass containers are indicators of altered surface chemistry or contamination. This may...
(All Rights Reserved)