INNOVATION
The US Food and Drug Administration (FDA) reacted by implementing recalls. For the respective manufacturers, this seemingly minor occurrence can then have costly consequences.
There is good news, however. New packaging concepts help bring delamination under control with SCHOTT offering perhaps one of the most innovative ones.
Delamination is nothing new for the pharmaceutical industry, and the use of glass as a packaging material has never been questioned. On the contrary; pharma glass offers very high chemical resistance – and thus is perfectly suitable for storing medications safely.
Yet, there is still a risk of unfavorable interactions under certain conditions. The glass surface of the container and the drug interact and can cause glass delamination over time.
It is this very process that SCHOTT has investigated very thoroughly. Based on its findings, the company has launched two unique innovations:
Pharmaceutical vials that minimize the risk of delamination
Unique homogeneous inner glass surface ensures chemical stability
A time lapse test process that monitors this property.
“Why does glass delaminate in the first place? A lot of research has been done to learn what causes this. Conventional converting processes can lead to inhomogeneous surfaces inside a vial and thus make the glass more vulnerable. With this in mind, we have developed a way to produce vials to ensure that this problem will not occur later on.” Dr. Bernhard Hladik, Senior Product Manager responsible for SCHOTT Vials DC
The first step is to select the right type of glass by focusing on its chemical and hydrolytic resistance.
This criterion is met by the glass tubing known as FIOLAX®, a pharmaceutical glass product that was invented by SCHOTT more than a century ago and has since become the de facto standard in the pharma industry. Its exceptional properties are the basis for SCHOTT Vials DC – with the benefit of higher safety.
SCHOTT was able to determine the measurable risk of delamination by performing a simple trick. The vials were turned upside down and then stressed using hot water vapor. The resulting critical zones were then measured conventionally by using stereomicroscopy. Drawbacks: this requires the trained eye of a professional and is not objective. Furthermore, it takes time. Too much time, in fact, to be able to intervene in the current production setup.
4 hours
121 °C
in an autoclave
2 hours
121 °C
in an autoclave
flame spectrometry
The key feature? Thanks to this robust statistical process, it is now possible to determine a threshold value for the risk of delamination. Thus, 4.5 mg of sodium oxide per liter is the limit for a 2 mL vial. If the value is lower, the vial is able to withstand the onset of delamination.
We monitor the limit by performing random checks on the current production. In the event that an alarming value is reached, we can intervene very quickly.
The concept is receiving a lot of attention from the pharma industry. No wonder, given that SCHOTT Vials DC have proven their performance in various screening studies.
“Delamination Controlled” vials with a standard ISO size of 2 to 10 milliliters are currently available from stock. They can even be used with approved medications without having to undergo new registrations with the respective authorities. We can even develop individual formats to meet specific needs. In fact, we have proven this flexibility in recent customer projects.
Let’s make medications even safer.
