SCHOTT Pharmaceutical Systems is showcasing its complete portfolio of products and solutions for the field of primary packaging for the pharmaceutical industry at Innopack in Frankfurt (Stand 40A24), which is taking place as part of CPhI trade fair from October 25 to 27, 2011. Tobias Nemeth, Business Development Manager at SCHOTT, will be presenting at the Innopack Speakers Corner on Wednesday, October 26 at 3:30 pm. The topic of his presentation will be “Critical to quality aspects of glass syringes for use with auto-injector devices”.
Recent market recalls for injectable drug products due to visible flaky particles have put the topic of glass delamination into the focus of the industry. Based on more than 125 years of experience and strong analytical and material competence, SCHOTT offers different high-quality alternatives to conventional primary pharmaceutical glass packaging, but also provides analytical lab services for assessing the risk and root causes for glass delamination.
Resistant to delamination
In order to avoid the risk of glass particles, pharmaceutical companies can switch to SCHOTT TopPac® products which are made of COC high-tech polymer. It is also possible to benefit from the advantages of glass and at the same time being protected against glass particles. SCHOTT Type I plus® vials feature a coating layer that protects the formulation and the glass surface at the same time. Data generated in a six month accelerated ageing study confirms the resistance of SCHOTT Type I plus to delamination.
Tailor-made analytical lab services
A unique combination of specialized analytics and the company’s expertise in materials, products and processes enables SCHOTT pharma services to support pharmaceutical companies with test methods to assess the root cause and risk of delamination for different drug formulations and containers. With a self-developed delamination screening test, the likelihood for delamination occurring during the shelf life of a product can be assessed. The formation of particles on the container surface is often observed only after an extended time of storage. SCHOTT pharma services offers an accelerated compatibility test that reduces the testing period from months or years down to a few days. In cases where particles have already occurred, an in-depth particle analysis can help drawing conclusions on the particle development and forming process as well as creating strategies to avoid them.