Pharmaceutical Packaging for Freeze-dried Drugs

Jürgen Thürk

forma vitrum ag

St. Josefenstr. 20, CH-9001 St. Gallen, Switzerland

Tel: +41 71 274 16 00   Fax: +41 71 274 16 16
Email: juergen.thuerk@formavitrum.ch

Biography 

Jürgen Thürk, born 1948 in Saarbrücken (Germany), is head of the development group for SCHOTT forma vitrum.

He graduated in Chemistry and received his Ph.D. in Physical Chemistry from the University of Saarland.

After his studies he joined the Schott Group where he was in R&D responsible for the development of fire resistant glazing and glass ceramics.
 

Thereafter he changed to the Schott Pharmaceutical- Packaging Business Unit were he took over the technical responsibility of Schott Glaskontor, Müllheim (Germany). In 2000 he changed to SCHOTT forma vitrum, St. Gallen (Switzerland) where he is responsible for the development of new products/processes, camera inspection- systems and production facilities.

He is convenor of the ISO TC 76 WG 6 and member of several ISO/DIN- working groups; main subject: primary packaging materials for medicinal products.

Jürgen Thürk has published several papers (amongst others co-authored the book “Freeze Drying/Lyophilization of Pharmaceutical and Biological Products) and is inventor/co-inventor of many patents.
 

Company Profile 

SCHOTT forma vitrum is one of the world’s leading suppliers of parenteral packaging for the pharmaceutical industry. More than 500 production lines in 10 production sites worldwide produce more than 6 billion syringes, vials, ampoules, cartridges and special articles made of tubing glass or polymer. Excellent raw materials, state-of-the-art manufacturing, the use of the latest technologies, continuous research and development enable developing innovative product solutions meeting the high demands of our customers. The back-up possibilities offered by our production sites situated all over the world provide flexibility, reliability and security to our partners. Our production sites operate in a GMP environment and our products comply with the international standards USP, EP and JP.

Abstract

Glass is unique in that it provides an optimum combination of important characteristics for primary packaging: it is durable, inert, clean, and offers the pharmaceutical drug a sterile integrity protection with optimal transparency.

One drawback which remains is its fragility: in everyday life we have learned to live with this characteristic of glass and have developed safety precautions and appropriate handling methods to reduce the risk of breakage.

In the pharmaceutical industry, particularly those manufacturing and filling parenterals, a breakage or crack of the glass container is unacceptable, and not simply due to economic reasons. Even small microcracks in the glass vial may lead to a non- sterile condition in the filled package. It must then be judged as a critical defect which could endanger human life and health. It is therefore justified to ask for “zero defects” in the final product in this regard, and this is the challenge to be mastered at every level of production including the supply and processing chain.
A still more special case is the freeze-drying process: this process is expensive and therefore worthy of a total cost optimization.

The challenge was to develop and make available glass containers which are specially optimized for the freeze-drying process, i.e.: Optimization of mechanical resistance against breakage in combination with good heat transfer of the glass container in the freeze-drying process.

To meet these requirements a new design of the glass container was necessary. To optimize the design with regard to strength/stress and heat transfer it was necessary to understand the stress behaviour of the glass container and the heat transfer in the freeze-drying process.

Optimized vials according to the findings of this investigation, specially designed for freeze drying have shown their reliability over years.