Packaging: the experts' view

What trends have you witnessed in the pharmaceutical packaging industry in the last 2 years?

Klefenz: We have seen a geographic shift in investments, towards Asia. Not only are global companies investing in Asia, but so too are the large local companies, particularly in India, China and South East Asia.

Peters: We have seen a trend towards changing focus in packaging design; product managers are focusing on customer convenience — making packages easy to open or including reclosing features. There is a need, however, for more product tracking through the entire process (e.g., 2D matrix code, track and trace).

We have also noted a growing interest in smaller batch sizes as well as data management and Manufacturing Execution Systems (MES).

Tomasi: Multinational enterprises have cut down on investments as part of a general reduction in costs, and are instead opting to purchase efficient lines that meet safety standards and do not have too many optional units or accessories: such lines are simpler than previous systems yet still include cutting-edge technologies.

Friedbert Klefenz, Bosch Packaging Technology

Schäfer: We have noticed a continued strong growth in the biotechnology and biopharmaceutical sectors. In some cases, these highly efficient and sometimes very costly substances require specific technologies; for example, 100% in-process control (IPC), with regard to filling and packaging processes. The IPC developed in this context is also universally applied in 'conventional' projects and can realize major product savings. The issue of output under IPC has also become very topical.

Barrier technologies, such as isolator technology, have gained more acceptance and significance.

Lyophilization seems to be playing an increasing role, ensuring lasting storage life of these bioproducts. The FDA returns for new product registrations demonstrates the increase in lyophilized biopharma products.

A growing number of clients are interested in moving towards sterile disposable systems for the actual filling because this can simplify handling and reduce costs with respect to cleaning and reducing downtimes. These disposable filling systems are also suitable for upgrading existing filling systems with sterile transfers into and out of the isolator.

Carsten Peters, Gerhard Schubert GmbH

In addition, we have seen a growing demand for well coating systems in clinical diagnostics. This trend is a reflection of the advancing development of new diagnostic tests required for novel biotechnological drugs and therapies.

Optical and sensor equipment that control the packaging processes has been gaining popularity during the past 2 years — for biotechnological and conventional products alike. Aspects of product safety, documentation and statistic evaluation of line efficiency accelerated the trend.

The trend for outputs, with a current maximum of 60000 units/h for prefilled syringes, continues to be the alldecisive factor for many projects. This is especially so with vaccines, which is of particular significance in light of the current rise in flu vaccine production.

Generally, there is a growing preference for turnkey projects — for charging a one-stop supplier with the responsible planning, development and implementation of a complete project.

With more companies investing in the emerging markets, how has this affected your company and how has your company responded?

Klefenz: In 2008, 25% of our order intake came from emerging countries. These countries (China, India, South East Asia, Russia, Latin America) are taking a growing share of our order intake and sales portfolio, of both locally manufactured products and imports from Europe. Now, more than 10% of our workforce operates from these countries (including production) and we have five production facilities to serve this customer base.

Piero Tomasi, Marchesini Group

Peters: We are tracing the marked activities in those markets closely to develop relevant technology for the near future. Secondary and end-of-line packaging, for example, is still operated manually from our facilities in Asia. It is expected that these markets will soon require more automated solutions.

Tomasi: We are experiencing a rise in sales and the growing success of our products in these markets. To get closer to countries, such as China, India and South East Asia, we have invested in a widespread sales network, opening new organizations and services across the territory, for example, in India, China, but also in Dubai and Jakarta.

Schäfer: Optima already has a branch in China, which is ready to operate within the pharmaceutical sector. However, we are on 'hold' and are closely observing market trends. We have been organizing events at numerous conferences and hosting standalone meetings over the past few years to gain valuable feedback from Asia and to help us to define our strategy.

Jürgen Schäfer, Optima Group Pharma GmbH

Have you witnessed any changes in market dynamics across Europe in recent years?

Klefenz: Certain Eastern European healthcare markets, particularly Russia and Ukraine, are growing and, in fact, some are even being supported by the US. This growth in healthcare provision will naturally lead to increasing investments in the region.

At Bosch, between 2007–2008, we experienced a 7% decrease in sales from North America (accounting for 28% of all sales in 2007 and 21% in 2008), in spite of an overall increase of 8% in total sales. This shortfall was made up for by a rise in sales in Asia and Europe. We have made huge levels of investment in Europe during the last 2–3 years, from Scandinavia down to Turkey; there were almost no countries in Western Europe where the level of investment was either stagnant or negative, except in the UK. In the UK in particular, differences in exchange rate has led to reduced investments. Conversely, we have seen strong growth in Turkey; this market is growing in importance.

The 2010 EU Braille mandate

Peters: The Eastern European market is moving fast. National companies have the market share and global players are either building new plants or buying local facilities. Turkey is also making an impression in the pharma market.

Tomasi: Generally speaking, we have noticed the movement of production centres towards eastern Europe (countries of the former eastern area, especially Poland, Hungary, Slovenia and Romania) and towards up and coming countries, such as China.

Marchesini's presence in Eastern countries is however already consolidated and we have always been very active in these countries, consequently we are talking about a trend that we have already been following for some time.

Schäfer: Compared to Europe as a whole, market developments in Eastern Europe and Russia are particularly critical. There is a general upward trend for investment, but these markets are subject to intense fluctuations directly linked to the global economy.

Green pharma waste disposal

What can companies do to reduce the environmental impact of pharmaceutical packaging and waste?

Klefenz: Using disposable systems for smaller batch sizes reduces the need for cleaning , which in turn affects the amount of energy required. The energy balance is much better than for a conventional system because you do not need to clean or sterilize the equipment. We have made comparisons and for us, it makes sense from an energy-saving point of view to invest in disposables; disposable units can be incinerated after use.

Peters: New packaging ideas are important; for example, syringes do not need to be packaged into blisters and then into a carton, which reduces the amount of packaging material required.

Tomasi: By developing machines that can use new environmentally-friendly materials, such as polylactide (PLA), pharma companies can make a difference to the environment. We have noticed a reduction in the demand for flatblank and shrink wrapping machines, which exploit plastic material. Instead, customers are favouring cartoning machines, which use paper and other easily recyclable material.

Achieving sustainable packaging

Schäfer: In the coming years, there will be an increasing focus on personalized medicine. Consequently, the volume of primary and secondary packages of pharmaceutical products will be minimized, resulting in reduced transport costs and waste disposal expenses. Such innovations, however, must by no means affect package integrity: top priority has to be placed on maintaining density of packaging materials and sterility. Packaging methods will change, and filling and packaging machinery will have to adapt. Pharmacists are already endeavouring to create new waste-reduced packages.

What new technology is your company currently investing in and why?

Klefenz: We have invested in new sealing technologies, in particular, in ultrasonic sealing, which has been introduced for flow pack packaging. It is a good, safe method of sealing that does not introduce heat to the process because the packaging material is sealed by ultrasonic waves. It is also extremely tight and, therefore, addresses quality and security issues. A track record of the energy used for sealing can also be provided with this technology — this is especially important for pharma companies to ensure that the sealing process is constant.

We are also investing in disposable filling systems, which are great for smaller batch sizes; they're energy efficient, which translates into savings in money and labour.

Automated proofreading technology

Peters: Schubert is working on fast change-over and intelligent line clearance features.

Tomasi: We are completing the offer of production lines for the pharmaceutical industry, focusing specifically on machines and technologies for filling and packaging products in a sterile environment. Furthermore, we are investing increasingly in robotics — technological solutions that guarantee outstanding flexibility.

Schäfer: Disposable filling technologies still hold great potential, and thus we have invested in proprietary filling system projects. In addition, we have entered into a partnership with Lugaia STS and now hold a 50% interest in the Swiss company. Lugaia offers certified and patented disposable procedures that support sterile transfers into and out of isolator-protected areas. The method is based on presterilized foils (bags) and special welding techniques.

In our view, the disposable approach is promising, because it allows considerable saving of investment costs and can contribute to simplifying the design of a number of processes without affecting sterilization integrity.

What will be the key growth areas in the pharmaceutical packaging industry in the next 5 years?

Klefenz: From an innovation point of view, there is a clear trend towards more sophisticated machinery which will offer pharmaceutical suppliers important competitive advantages through high levels of availability and automation combined with enhanced flexibility. From a regional growth point of view, opportunities will be more prominent in pharmaceutical emerging markets, and China will offer the strongest growth based on its rapidly expanding pharmaceutical manufacturing capabilities. To consolidate Bosch Packaging Technology's strategic position in the pharmaceutical market, we have concentrated our portfolio on five central competence areas: process technology, primary and secondary packaging, qualification and services.

Peters: Singleuse prefilled syringes will continue to grow rapidly and I predict that we will see the introduction of new oral dosage forms that will replace certain injectable therapeutics.

Tomasi: The pharmaceutical production market is expanding, particularly in India and China, Latin America and Eastern Europe. This trend will continue during the next few years and is one to which the pharmaceutical packaging industry should pay special attention.

Schäfer: Key growth areas in the pharma packaging industry will be in turnkey projects, lines for biotechnological pharmaceuticals, pharmaceutical lyophilization, disposable systems, flexible processes, cost efficiency with innovative systems and more emphasis on overall equipment effectiveness.