Effective Alternatives for Ammonium Sulfate Treated Pharmaceutical Glass Vials

Rubrik: Technik

(Treffer aus pharmind, Nr. 01, Seite 139 (2021))

Crawford A | Zuccato D | Hladik B

Effective Alternatives for Ammonium Sulfate Treated Pharmaceutical Glass Vials / Crawford et al. • Alternatives for Ammonium Sulfate Treated Glass Vials · Crawford A, Zuccato D, Hladik B · SCHOTT Pharmaceutical Systems, Lebanon, PA (USA)
Alkali-borosilicate glass has been the material of choice for pharmaceutical primary packaging over the course of decades [ 1 ]. This is due to its technical characteristics, such as its chemical durability, optical transparency, thermal expansion, and mechanical strength, as well as business considerations of speed and cost of manufacture along with raw material availability. These features allow alkali-borosilicate glass to fulfill the requirements to contain a plethora of drug materials in a safe, reliable, and effective manner [ 1 – 4 ]. While originally soda-lime-silicates were the first glass containers produced to store valuable substances, early scientific endeavors found ...

Optimizing the Inner Surface of Primary Packaging

Rubrik: Technik

(Treffer aus pharmind, Nr. 09, Seite 1192 (2020))

Rupertus V | Hladik B | Löber D

Optimizing the Inner Surface of Primary Packaging / Siliconization versus PICVD. What is the difference? · Rupertus V, Hladik B, Löber D · SCHOTT Pharmaceutical Systems, Mainz
The trend to focus more and more on biomolecule-based parenterals for drug development opens automatically a far more complex field of interaction processes with the primary packaging container during drug shelf life. Adhesion processes on nanoscale at the inner container surface causing denaturation of the respective molecules as well as dissolved glass elements in the buffer solution lead to a variety of complex interaction processes, also depending on the individual glass compositions available in the market. Type I borosilicate glass, which has been used for decades for nearly all application fields of parenteral pharmaceuticals, has become the gold standard for ...

Surface Hydrolytic Resistance Test or Delamination Quicktest

Rubrik: Analytik

(Treffer aus pharmind, Nr. 11, Seite 1547 (2017))

Hladik B | Rupertus V

Surface Hydrolytic Resistance Test or Delamination Quicktest / What are the Correct Criteria for Assessing the Risk of Glass Delamination? · Hladik B, Rupertus V · SCHOTT Pharmaceutical Systems, Mainz
The detachment of flakes from the inner surface of a glass container – also referred to as glass delamination – has been described as early as 1965 [ 1 ]. Yet, in 2010, the pharmaceutical industry witnessed the first major recall due to glass delamination resulting in excess of tens of million dollars for this sole incident. Once delamination is discovered in a commercial drug product, it is already too late and the only option left is the recall of the product. Since glass delamination can take years before it becomes visible, a recall will likely impact the product already in distribution ...