Pharmaceutical Packaging

Michael Bonewitz

Pharmaceutical Packaging is a Matter of Trust

Manufacturing primary pharmaceutical packaging has been a core competence for SCHOTT for decades. Today, this area has developed into one of the leading sources of revenue, in addition to ranking among the entire company’s most innovative and promising fields.

Our earth is home to approximately six billion people. If SCHOTT had direct access to every person on the planet, each individual could be presented with a primary packaging product from SCHOTT. After all, with its roughly 500 production lines and ten manufacturing sites based all over the world, the company manufactures more than six billion syringes, vials, ampoules, cartridges and other specialty articles made of tubing glass or polymers year after year.

Parenteral packaging is the technical term for medical containers that store medications that are administered directly into a patient’s bloodstream, in other words, injectables. By now, one should certainly be able to grasp the high level of responsibility that manufacturing these types of primary packaging entails. After all, these sometimes highly sensitive active ingredients come into direct contact with the glass or polymer surface of the container.

Accordingly so, the regulatory requirements with respect to manufacturing conditions, but also the quality regulations of the pharmaceutical industry, are quite demanding. As if this wasn’t enough, each year, new medications, new applications, new active ingredients and biotech products with highly sensitive proteins hit the market. For manufacturers, this means not only having to engage in a footrace against time, but also having to compete by offering the best quality, highest safety and best possible delivery reliability.

For SCHOTT, the starting position for surviving in this highly competitive market environment could not be better. After all, SCHOTT not only manufactures the pharmaceutical packaging, but also the preliminary products: pharmaceutical tubing made of highly resistant special glass. With a production capacity of more than 120,000 tons, as well as sites in Germany, Spain, Brazil and India, the company also ranks among the world’s leaders in this segment, as well. SCHOTT-Rohrglas in Mitterteich, Germany, is both the most important production site and a center of competence in this area. Here, special glass tubing, capillaries and rods are manufactured using a broad spectrum of glass types and dimensions to set new standards. The company based in Mitterteich also became the world’s first manufacturer of tubing glass to be certified according to iso 15378. As a result of the improvements to process stability that this entails, fluctuations in quality can be reduced even further and the gmp (Good Manufacturing Practice) demands of the pharmaceutical industry can be met.

Products that meet the highest demands for quality are currently in great demand. For this reason, SCHOTT created its own »TopLine« range of products; customized packaging solutions for the pharmaceutical industry. »TopLine« products are designed to perfectly meet the demands of specific medications and the manufacturing environments of customers. For instance, vials that are used to store highly sensitive medications must fulfill a number of special requirements. They are not allowed to contain any scratches, deformations or micro cracks. At the same time, they must be absolutely free from even the slightest level of contamination that could possibly react with the substances. “This is critical, particularly for the packaging that is used with innovative biotechnological medications that are injected to treat ailments, such as cancer or HIV infections, but also toxic substances,” explains Bernhard Elsener, head of Marketing and Sales for the Pharmaceutical Packaging Business Segment at SCHOTT. “In the light of the high risks and possible high costs, packaging solutions of a lesser quality would be incapable of meeting such high demands for quality,” he adds. However, even with less expensive medications, the use of »TopLine« containers can prove to be worthwhile for pharmaceutical companies, because they can increase the efficiency of their filling and packaging processes and reduce the frequency of, or even completely avoid, incoming product inspections.

Ultra-thin barrier layers prolong the life spans of medications

Pharmaceutical containers made of glass, or even polymers, with high-tech barrier characteristics that substantially improve the chemical stability and increase the storage life of medications over conventional pharmaceutical containers are yet another important innovation from SCHOTT. This specialty is marketed globally under the brand name SCHOTT Type I plus®. Due to the progress now taking place in the area of biotechnology, this brand is meeting with a sharp increase in demand. With the Plasma Impulse Technique (picvd) developed by SCHOTT, the vials are coated on the inside with an extremely thin layer of silicon dioxide. The product advantages include a more homogeneous surface, better barrier characteristics and higher stability of the active ingredient.

In the course of globalization, an international approach to production represents an important success factor. “This allows us to guarantee our customers all over the world the same high quality,” Elsener explains. The SCHOTT network of manufacturing sites extends from Brazil, Mexico, Colombia and the United States to France, Germany, Hungary and Switzerland, all the way to Indonesia. “This gives us a high degree of delivery reliability, an aspect that truly distinguishes us from our competitors,” says Elsener.

And SCHOTT continues to invest. A new production facility for vials and ampoules is currently being built in China. This makes SCHOTT the first international manufacturer of primary pharmaceutical packaging made of glass to establish a manufacturing site in this country. In India, as well, the other major growth market inside Asia, a new Fiolax® melting tank went into operation at the end of March.