Clash of the Titans

Super-rivals glass and plastic square off for patient safety

By Steven Kuehn Editor in Chief

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CoverOct1Specifying the best material to serve the primary packaging requirements for a given pharmaceutical used to be pretty easy, considering there was virtually only one champion to call on: Glass. Glass was Pharma’s packaging Superman, a hero with well known virtues; strength, purity and transparency. For millennia there were few materials out there that could rival glass’s dominance and reputation.

Glass as a material has been around for a long time, but it wasn’t until about the 1st century BC, that glass blowing was discovered in the Middle East. This advancement created the industry. Glass vessels could now be mass produced, and more economically than pottery vessels.

And the rest is history as they say. During the ensuing millennia, glass as a packaging material came to dominate the world’s food, beverage and pharmaceutical industries; there simply were few or no alternatives. That is, until scientists started uncovering the attributes of organic polymers found first in naturally occurring substances like gum and shellac, then later developing chemically modified materials like galvanized rubber and nitrocellulose. By 1900 the first synthetic plastic Bakelite was developed by Belgian chemist Leo Baekeland. Advances came quickly after that with the likes of BASF, ICI and Dow bringing commercial/industrial ready polymers to market beginning in the ’20s.

As we reach the midpoint of this century’s second decade, material scientists continue to hyper-refine plastics and glass to enhance positive attributes and mitigate less-than-desired attributes relative to Pharma application and commercial/industrial scale economies. The market for pharmaceutical packaging has become immense and is showing no signs of slowing down; leading market research firms predict demand in the U.S. will grow about 5 percent a year and reach ~ $22 billion by 2018, representing about a third of the global market which Freedonia Group pegs at $66 billion by 2017 and growing at 6.4 percent annually.

Indeed, glass and plastic have become Pharma packaging’s superheroes — both working tirelessly to safely deliver medicines to a world plagued by evil-doing disease. But as our heroes pursue this common cause, packaging’s dynamic duo have also become super rivals. However, as far as superhero-to-superhero conflicts are concerned, this one only goes so deep. Suppliers and users understand that any packaging decision is led by the formulation of the drug and ultimately patient safety.

GLASS, THE PROVEN DEFENDER

 In an extensive American Pharmaceutical Review blog titled “Pharmaceutical Glass Containers: Proven Solution for Primary Parenteral Packaging” Gerresheimer Glass Inc.’s technical and quality managers noted that in 2012, market share for primary packaging of injectables was approximately 98 percent, representing 23 billion primary containers for parenterals. According to Gerresheimer, for the storage of parenterals, borosilicate Type I glass is the material of choice. Borosilicate glass was developed to have superior chemical and temperature properties compared to soda-lime glass; it has a stable matrix that reduces thermal expansion and resists chemical attack. It is inert, chemically stable and nonporous.

SCHOTT Pharmaceutical Packaging, the industry’s leading glass supplier, says it delivers 9 billion containers per year and that includes ampoules, vials, cartridges and both glass and polymer syringes. “We are working in the pharma industry, so we abide with all regulations,” says Anil Busimi, head of global product management syringe business at SCHOTT, “which our customers — like the Pharma companies — have to ensure that their products are produced as per specifications and GMP. We fulfill all the regulatory requirements.” At the same time, says Busimi, SCHOTT ensures Pharma quality standards are met by its suppliers. “SCHOTT is a major producer of glass tubing, [a pre-fabrication form] which is used for [Pharma’s] primary packaging containers.

The use of glass pharmaceutical containers remains pervasive, especially for the thousands of well-known, broadly administered and increasingly generic injectable drugs. Materials and production systems are well understood, and in the context of large commercial drug manufacturing operations, there are hundreds of GMP compliant and validated fill-and-finish lines operating out there and a host of reliable glass container suppliers with established supply chains. Data on compatibility and drug/material interactions are both plentiful and accessible to all drug developers and Drug Master Files are kept by regulators. SCHOTT notes that having the technological expertise to support current products when problems come up helps sustain the company and glass’s dominance in the category. SCHOTT’s scientific advisor Dan Haines explains that, “because most of our products are components within other systems, there can be interface problems. Sometimes there are drug interaction problems. So having the technical expertise to help … is very important.” SCHOTT provides this support through its pharma services group as does Gerresheimer and other glass container manufacturers. “In the pharmaceutical industry, it’s a [relatively] slow evolution from one drug platform to the next, says Haines, “so there’s quite long lead time, which is good. But on the other hand, you pretty much have to have rock-solid solutions when going from the current generation to the next generation.”

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