SCHOTT solutions no. 1/2012 > Pharmaceutical Services
The stress conditions inside a glass that is being put to pharmaceutical use can be reconstructed inside an autoclave. Photo: SCHOTT/T. Hauser
Glass has a long tale
How can drug stability be guaranteed in pharmaceutical packaging? When will a glass container break? Thanks to its unique analytical expertise, SCHOTT pharma services can answer important questions like these.
Increasingly stringent demands are placed on packaging as progress is made in the area of medicine and competitive pressure in the promising global pharmaceutical market increases. Today, systemic packaging products like syringes contain a wide variety of different materials, including glass, metal, rubber, silicone oil, and adhesives. By no means can these container systems be permitted to react with their contents and contaminate a medication, especially if it is a highly sensitive proteinbased biotherapeutic. Making sure that containers of medications do not break when they are treated properly, whether during the filling process, transportation, or use, is an equally important issue for the pharmaceutical industry. Regulatory authorities like the FDA in the United States also take the safety of the pharmaceutical packaging into consideration when they register new medicines. All of these aspects have brought about a rethinking process. “As pharmaceutical products become increasingly complex, the demands placed on their packaging continue to rise. It is much more difficult to preserve the stability of a modern biotech product over its entire lifetime than traditional chemical ingredients. More analytical tests are needed in order to ensure the stability of a medication. For this reason, we are seeing much greater interest in our services,” explains Dr. Uwe Rothhaar, head of SCHOTT pharma services.
This service unit has been providing the pharmaceutical industry with comprehensive analytical services and development support on pharmaceutical primary packaging products since 2009 (see overview, p. 12). A multidisciplinary team of experts from Mainz (Germany), St. Gallen (Switzerland), and Duryea (U.S.A.) has been offering its support to customers all over the world. Besides conducting its own state-of-the-art instrumental analytics, it also uses the resources of SCHOTT’s main research and technology development department. This work is done in accordance with the standards of Good Manufacturing Practices (GMP) and all of the laboratory operations have been accredited based on the DIN EN ISO 17025 standard. These services are backed up by more than 125 years of accumulated knowledge of special glass and other materials development, manufacturing, and processing. “Unlike most of the other analytical laboratory service providers, as a manufacturer of pharmaceutical packaging, we are also familiar with everything that ranges from the filling process to sterilization and use,” Uwe Rothhaar notes.
SCHOTT pharma services uses state-of-the-art equipment like a Time-of-Flight Secondary Ion Mass Spectrometer (TOF-SIMS) to analyze the surface properties of glass. This allows for chemical attacks on glass or surface contamination to be examined, for example. Photo: SCHOTT/C. Costard
Unique expertise in all areas
This extremely unique know-how allows for risks to be detected early and solutions to be found. For instance, so-called extractables and leachables are analyzed using chromatographic techniques. These are organic compounds that are invisible to the eye and can migrate from the container into the drug solution, especially the components of the container itself, the stopper, or the adhesive used.
Possible interactions between a medication and its packaging represent yet another important focus of analysis. During glass delamination, for instance, inorganic flakes or lamellae can detach from the interior glass wall and interfere with the effectiveness of the medication or even endanger the health of the patient. To distinguish between a glass flake and other foreign body particles, first a sample is filtered and the particles are analyzed. Furthermore, by using the appropriate techniques, it is also possible to cause accelerated aging and thus stimulate the delamination effect that would perhaps normally only be observed two years later. “This enables us to test various packaging products and their contents in only a short time, a major advantage for our customers,” explains Dr. Peter Prazeller, Product Manager at SCHOTT pharma services.
Testing the stability and reliability of the packaging itself is a third pillar of competence developed in close cooperation with the main research department. The question of whether a container has a weak point and what actually caused the breakage that occurred is often asked. “Glass has a long tale to tell, but we must be able to ‘read’ it. Understanding what actually happens when glass changes shape and where stress occurs is only one of our unique skills. This is important because each glass product reacts differently,” Uwe Rothhaar emphasizes. Samples are subjected to pressure in overload tests to confirm the stability of the glass containers. The pressure is steadily increased until it causes breakage. Thus the container defect rate under normal pressure can be estimated with high confidence based on these statistical evaluations. According to Dr. Peter Prazeller, there is increasingly higher demand for these types of services: “We are already working together with many major pharmaceutical companies on ensuring the safety and effectiveness of these products in the interests of the patients.” <|
Under no circumstances may pharmaceutical packaging ever be allowed to react with its contents. SCHOTT pharma services works closely with pharmaceutical companies to ensure the safety and efficacy of these products. Photo: SCHOTT/C. Costard
SCHOTT pharma services
SCHOTT pharma services