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Not All Glass is the Same
Sundeep Prabhu, Vice President Marketing and Sales, Tubing Division, SCHOTT Glass India Newer packaging materials have been developed and made available to suit the different needs of the pharmaceutical industry. But even then, one of the oldest materials, i.e. glass, can never go out of vogue. This article talks about why high quality glass tubing is crucial to secure India's pharmaceutical industry in growing business.

As pharmaceutical companies search for new growth opportunities, they have realised that some of the most promising are to be found in India. Trends such as raising disposable incomes and a greater penetration of health insurance, but also the spreading of chronic diseases have been making the Indian market grow strongly.

In 2010 already, the Economic Times cited a study predicting that pharmaceutical and engineering would 'topple IT as big paymaster'. Today, the industry is still dominated by subsidiaries of multinational companies using India as manufacturing hub for the Asian region. Domestic companies however get up to speed. Clearly, what stands them in good stead is their expertise in reverse-engineering processes for low-cost manufacturing as it has always been quite typical for Indian companies.

The confidence of Indian pharmaceutical companies has grown along with the market. Apart from domestic sales they more and more seek to increase their exports to mature Western markets. This, however, calls for stronger compliance with international quality standards as global pharmaceutical companies have to be obliged to highest diligence. This applies especially to high-end and injectable drugs. Here the course to a quality level necessary for global competitiveness is set at the very beginning of the value chain: with the primary pharmaceutical packaging and the glass tubing that its made of.

Glass has established itself over the years as the most commonly used primary packaging for injectable drugs. It is melted at temperatures of more than 1500C, and this fire polishing process produces a dense, smooth non porous surface on which it is practically impossible for contaminants to settle. Its shape is extremely stable even at temperatures of up to 500C. It can be very easily sterilised, it is absolutely impervious to gas and withstands high inner pressure. Moreover, the transparent nature of glass permits simple checks of both, the container and the content.

Apart from chemical stability an important measure of the suitability of a glass for pharmaceutical containers is its resistance to water. A huge step was done by Dr Otto Schott in 1884, who carried out systematic investigations on glasses and developed the borosilicate glasses.

The water resistance of his borosilicate glass FIOLAX® was 30 to 50 times better than that of the other glasses used at this time. Nowadays, the classification of the various glass types according to their water resistance is described in international standards. For injectables only so-called Type I glasses are permitted for use.

Same but Different
However, not all Type I borosilicate glass is the same. Still, it differs in the composition of the glass, the chemical/ physical properties, its dimensional accuracy and the glasss cosmetic quality (glass defects such as airlines, inclusions, or micro cracks). This can have a significant Impact on the pharmaceutical filling process and thus affect the end quality of the drug. With an insufficient glass, breakage can occur, or stability issues in case the drug interacts with the container.

In order to be able to identify a high-quality glass tubing, one should especially pay attention to the following parameters
• Constant glass quality, less cosmetic defects and tight tolerances, allowing for a lesser breakage and reject rate in the production process
• Constant glass composition with low alkali content and reliable hydrolytic resistance leading to drug stability for long shelf-life
• Stable production process due to constant type I glass composition as basis for low alkalinity of containers
• Fulfi llment of international pharmaceutical requirements (USP, Ph. Eur, JP) and successfully fulfilled stability tests

Above and beyond the product, presence and experience of the supplier also add to the overall quality:

• How long has the company been on the market?
• Is it close ties with the pharmaceutical industry?
• Does the supplier provide the necessary production capacity at several sites to ensure steady supply?
• Have the plants been certified according to ISO 9001 and GMP (Good Manufacturing Practice) requirements
• Does the supplier transfer its glass know-how given by lectures and trainings and provide technical support?

SCHOTT for example support its partners along the pharmaceutical value chain in raising their quality and efficiency with a training programme called Fiolax Academy. This helps them improve their position on the domestic and international markets.

At these events, experts shed light on the composition and production of pharmaceutical glass tubing and how to fill these containers properly. Furthermore, SCHOTT encourages young academics to learn more about glass as basic material for state-of-the-art pharmaceutical packaging.

All in all, one can state that quality really starts with the best quality raw material. Combined with know-how exchange with experienced partners, this brings advantages to the whole value chain finally contributing toward the ability to compete.