SCHOTT solutions no. 2/2010 > Pharmaceutical Industry

Like all syringes from SCHOTT, forma 3s® syringes are manufactured using a fully automated process. After the glass tubes have been shaped, they are packaged and placed in trays (photo) before they are washed and siliconized in the clean room. Photo: SCHOTT/T. Hauser

Safely Packaged

Pressure on prices and globalization are challenging the pharmaceutical industry. Tomorrow’s medicines require sustainable innovations. Here, SCHOTT offers an answer with a bright future: safe packaging.

Michael Kömpf

The pharmaceutical industry is facing growing challenges all over the world. The development and approval of new drugs calls for increasingly higher investments in research and administration. At the same time, price pressures are increasing and losses due to the end of patent protection pose a threat that can reach billions. Generic manufacturers are already preparing for numerous blockbusters. According to an analysis performed by the consulting firm Accenture, patents on medications that account for 130 billion dollars in sales are due to expire by 2015.

Developing new growth markets poses yet another challenge. Above all, however, the pharmaceutical industry must keep patients’ needs in mind. This means new routes must be taken and sustainable innovations are in demand for the medicine of the future. In addition to the drugs themselves, its packaging also requires special know-how. Ensuring the best possible protection for these highly sensitive products calls for manufacturers with ideas. And Cornelia Yzer, the Director of the Association of Research-Based Pharmaceutical Companies (VFA), is not the only one pleading for “internationally accepted quality standards and an effective monitoring system”, due to increasing imports and exports of drugs. Nevertheless, “quality management differs from country to country,” notes Sarah Russell from the Health Systems and Services Department of the World Health Organization (WHO) in describing one of the major challenges that this development poses. If a drug isn’t packaged properly, even the best active ingredient will be of no help. For this reason, the Center for Drug Evaluation and Research of the American Food and Drug Administration, or FDA for short, has included packaging in the drug registration process. As the FDA puts it: “We can’t afford to allow packaging to become the weakest link in the global pharmaceutical chain.”
Photo: SCHOTT/Hauser & Eisenhut
SCHOTT has been meeting these requirements for quite some time already and manufactures one of the highest quality specialized glasses for pharmaceutical packaging in the same quality at four different sites all over the world. Fiolax® special glass tubing that has been on the market for 100 years has been improved for use in pharmaceutical packaging and is known for its high chemical resistance. It can be sterilized quite easily and features outstanding barrier characteristics for medications that protect them from being exposed to oxygen. Because of its low alkali content and optional UV protection, it allows the medication to retain its effectiveness for many years. The precisely shaped glass tube also tends to resist breakage and scratches, an important feature for machine processing during mass production of these containers.

“Perfect glass tubing is the prerequisite for perfect pharmaceutical packaging. And we offer both. Packaging manufacturers who receive their glass tubing from SCHOTT and the pharmaceutical companies all over the world that we supply with finished packaging products benefit from this. Highest quality – that’s our motto with respect to both stages in the value creation chain.”

Prof. Dr.-Ing. Ungeheuer, Chairman of the Board of Management of SCHOTT AG

Quality control and safety are also at the top of the list. In fact, SCHOTT even developed a coding system together with partners. A tiny 2D data matrix that measures only 2 x 2 millimeters is applied to the container by laser without reducing the stability and safety of the glass. Important data, including the filling station, quantity and date, as well as the dosage and name of the product, can thus be permanently recorded on the glass packaging and be read later on. Yet ­another advantage is that this allows for these products to be protected against counterfeiting.

This is a rather important aspect, because the pharmaceutical industry will need to combat counterfeiting even more actively in the future. According to a recent estimate from the WHO, for instance, every second anti-malaria drug in Southeast Asia is now already an imitation. At the 63rd WHO World Health Assembly, Eduardo Pisani, President of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), asserted that “combating counterfeit medications is important to ensuring quality assurance, safety and ­efficacy in all pharmaceutical markets.”
Above: SCHOTT Injentle™ only allows the drug to flow into the needle after the syringe has been opened by removing the needle shield. Photo: SCHOTT/T. Hauser

New Challenges

To support safer and easier administration of medications, prefilled syringes are being used by expert medical staff and in self medication more and more frequently. SCHOTT is responding to this trend with pre-filled syringes made of glass and COC high-tech polymers. For instance, the range of prefillable syringe systems was expanded only recently to include an innovation: SCHOTT InJentle™ is designed in such way that the drug does not come into contact with either the metal of the needle or the glue during storage. The new sterile syringe system does not permit the active ingredient to flow into the needle until after the syringe has been opened by removing the needle shield. This prevents drugs from interacting with the adhesive or the metal of the needle and thus improves storage and the stability of highly sensitive injectable drugs. In addition, the system allows for extremely thin needles to be used to reduce the pain of injections. The product group biopharmaceuticals also places special demands on packaging. These drugs help against increasingly frequent severe illnesses such as various types of cancer and rheumatic diseases. Among other things, they are characterized by extremely high specificity, selectivity, and completely new mechanisms of action. To prolong the stability of these extremely sensitive biotechnology preparations, they are generally freeze-dried following several purification steps. During so-called lyophilization, the drug is extracted from water until a powder-like substance remains. In order to be able to inject these biotechnology preparations into a patient in liquid form later on, they are dissolved in water once again. Here, coatings on the insides of primary pharmaceutical packaging that SCHOTT applies with the help of a PICVD process (Plasma ­Impulse Vapor Deposition) can make a valuable contribution. In combination with a modified container geometry, they improve the difficult process of freeze-drying. Thus they take the need for higher efficiency and cost reductions in producing these medications into account. And the demand for high-quality, easily processable packaging is growing. A study on the future of the pharmaceutical packaging market conducted by the consulting firm gbi Research predicts that the global packaging market will grow by an average of 6.9 percent to 68 billion dollars by 2015.
Hydrophobic coatings on the insides of glass vials help to improve the freeze-drying process used with premium quality drugs. Photo: SCHOTT/T. Hauser
As part of the consolidation processes in the pharmaceutical industry, entire production facilities are being relocated more and more frequently. According to the Association of Research-Based Pharmaceutical Companies in Germany (VFA), nearly all of the more basic substances are now being manufactured in India and China for the most part. The focus is shifting more and more to a group of emerging pharmaceutical markets, the so-called “pharmerging markets” with China, Brazil, Russia and India as the growth engines. According to a forecast from the consulting firm PricewaterhouseCoopers, the industry’s turnover in India, for example, will increase to around 50 billion dollars in 2020 – and thus classify the ­sub-continent as one of the top ten pharmaceutical markets. In addition, other developing regions like Argentina, Egypt, Pakistan, Poland and the Ukraine are expected to contribute around 48 percent towards global market growth by 2013 and even 70 percent by 2020. Despite the challenges, the global pharmaceutical market’s annual sales doubled to around 830 billion dollars between 2000 and 2009. The pharmaceutical industry has thus proven to be extremely resilient during the economic crisis. Nevertheless, the health care systems in Europe and the U.S. have been faced with a problem already for years. The older societies in Western industrial nations get, the higher the increases in costs for good medical care. In addition, drug prices are also on the rise as a result of the increasingly specific treatment options. Governments are therefore turning to regulatory measures such as discounts introduced by law and planned restrictions on access to markets – with significant consequences for the pharmaceutical industry. In other words, ever higher barriers are responsible for making the business with medications increasingly difficult to calculate.

Close to customers thanks to global presence

Photo: SCHOTT/T. Hauser
Pharmaceutical glass tubing and primary pharmaceutical packaging are among the core activities of SCHOTT. Our company ranks as one of the world’s leading manufacturers in both fields. Our product line includes syringes and cartridges, ampoules and vials, as well as special articles made of glass tubing and polymers. Our company founder Otto Schott introduced Fiolax® glass tubes to the market for use in manufacturing vials for drugs way back in 1911. Today, our group manufactures pharmaceutical glass tubing in Germany, Spain, Brazil and India. And with new facilities in India and China (2008), Argentina (2009), but also Japan and Russia (2010), the group has expanded its global network of manufacturing facilities for pharmaceutical packaging to include 14 countries. In addition, SCHOTT experts assist customers on complex problems by offering technological know-how and ­scientific services.