Phamaceutical Packaging

SCHOTT is currently experiencing double-digit annual growth rates with pharmaceutical vials that feature the quality option ”TopLine”. The major benefit for customers is that product specifications can be tailored to the individual demands of the medication and the manufacturing environment of the pharmaceutical company. Photo: SCHOTT/T. Hauser
Michael Bonewitz

High-End with ”TopLine”

The pharmaceutical industry is increasingly turning to customized solutions in the area of primary pharmaceutical packaging. The ”TopLine” products meet even the highest demands for quality.

The experts who work in the research departments of the pharmaceutical industry are relentlessly working on new combinations of active ingredients for use in the drugs of the future. At the same time, the innovations that are developed year for year continually pose new challenges for the companies that manufacture primary pharmaceutical packaging. New properties of drugs also place new demands on packaging. When it comes to pharmaceutical vials, for instance, SCHOTT provides its customers with three different quality options: ”StandardLine”, for instance, meets all of the international ­standards that apply to primary packaging, as defined by the so-called pharmacopoeia. This includes aspects like quality, testing and storage, distribution and labeling of medicines, as well as the substances used to manufacture them. In addition, the demands that apply to the containers that are used to store and administer medicines are also described here.

The second quality option from SCHOTT is called ”ClearLine” and includes products that meet superior demands. These pharmaceutical containers are not only manufactured according to strict standards, but are also monitored by camera without exception and inspected in terms of both their dimensions and visual appearance.

The third quality option is marketed under the name ”TopLine”. This stands for a customized product that is capable of meeting even the highest demands. The SCHOTT Group manufactures it at three global sites that are currently experiencing double-digit annual growth. The unique thing about ”TopLine” is that customers actually define their own product specifications. Close cooperation between the pharmaceutical companies and SCHOTT results in products that are especially designed to meet the unique requirements of a specific medi­cation and the customer’s production environment. Cross-functional project teams analyze the needs and requirements, determine the specifications, set the objectives and work step by step towards achieving improvements. Measurable results and customized solutions are achieved as part of the long-term quality improvement programs.

This process ultimately results in a product that is perfectly suited for the respective manufacturing process. Not only does it meet the customer’s demands with respect to its dimensions, it also lives up to customer specifications with respect to defect tolerances. Finally, optical requirements are formulated in order to avoid cosmetic defects like flaws and impurities.
Fiolax® glass tubing is used to make advanced pharmaceutical packaging. SCHOTT-Rohrglas GmbH is the world‘s first tubing company to be certified according to ISO 15378. Photo: SCHOTT/J. Meyer
In addition to using state-of-the-art machines, as well as optimizing processes with respect to shaping the glass, special emphasis is given to quality testing. Among other things, a globally unique production monitoring system that was developed together with a Swiss university is what makes ”TopLine” quality possible. This technology that was first developed more then ten years ago is better known as the ”Automated Inspection System” (AIS). Since then, it has been gradually optimized and modified to meet new demands. Basically, photographs are taken by special cameras from various viewing angles during the manufacturing process. This calls for between 120 and 200 digital photographs per vial. The advanced software is then able to compare the defined criteria for quality of each individual vial with the information stored in a database. Not only are these products inspected, those with flaws are also detected and removed and individual flaws are even identified and defined.

As a result, AIS can be regarded as yet another component of quality control in the manufacturing process. ”Here, complete command of the process is a key prerequisite for the entire production cycle,” explains Dr. Claudia Dietrich, Product ­Manager Vials & Coating.

Nevertheless, both production and packaging must be ­capable of meeting the highest demands for quality. When it comes to ”TopLine” products, this is done solely in 100,000 class clean rooms to reduce the concentration of particles in the air. Temperature, humidity and pressure are controlled in accordance with predetermined parameters. This conforms to the requirements of ”Good Manufacturing Practices” (GMP), a guideline on quality control that applies to manufacturing medicines, active ingredients and medical products and is mandatory for the pharmaceutical industry.

By the way, these products are not simply delivered in conventional shrink wrapping, but rather in Akylux boxes that protect the individually packaged pharmaceutical vials more effectively, due to the fact that these protects are separated from each other. This prevents the vials from possibly being damaged by rubbing against each other.

Customers reap a number of other advantages. For instance, they can either do away with their own inspection of incoming goods completely or at least devote less effort to this area. At the same time, they are able to increase the productivity of their own filling line as a result of the higher quality of the starting material. Less glass breakage occurs and the reject rate following filling declines, due to the fact that highly-sensitive inspection systems used to monitor the quality of the drugs no longer ­erroneously react to glass defects and sort out the costly end products.
The most modern of machines are used to produce pharmaceutical vials. The products are visually inspected using the highly advanced ”Automated Inspection System AIS”. Photo: SCHOTT/T. Hauser
” ’TopLine’ vials cost more than conventional products, however the process-related costs for customers are considerably lower,” notes Dr. Dietrich. The quality philosophy at SCHOTT begins already with the initial product, because only the highest quality materials are used to produce pharmaceutical ­packaging: Fiolax® brand glass tubing from the SCHOTT Business Segment Tubing. In 2006, its lead company SCHOTT-Rohrglas GmbH has been the world’s first tubing manufacturer to be certified according to ISO 15378. Thanks to its very good barrier characteristics, its high hydrolytic and chemical resistance, as well as its excellent esthetic characteristics, this specialized glass from SCHOTT is regarded to be the ideal preliminary product for manufacturing high-quality primary packaging for medical applications. Low geometric tolerances that allow for the best possible automated processing and compliance with the most important pharmacopoeia round off the range of benefits.

The ISO standard 15378 was developed especially for manufacturers of pharmaceutical packaging materials. As a result of the certification process, SCHOTT-Rohrglas examined its processes much more closely and was, therefore, able to improve them in a number of ways. For example, automated online process control systems are now in place to guarantee the consistently high quality of its products. The system is supported by a database and calibration and monitoring of the measurement instruments is based on real-time data. As a result of the improvement in the stability of this process that accompanies this measure, higher yield and more consistent quality can be achieved within a given specification. This, in turn, represents an important prerequisite to supplying top products to the ­pharmaceutical industry and, ultimately, consumers, as the end users.