Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

SCHOTT Introduces New Pharmaceutical Vials with Minimized Delamination Risk

Published: Thursday, October 24, 2013
Last Updated: Wednesday, October 23, 2013
Bookmark and Share
SCHOTT Vials DC: Innovation based on optimized manufacturing technique and patented SCHOTT Delamination Quicktest / Threshold values for delamination can be set for the first time ever.

SCHOTT will be presenting SCHOTT Vials DC - a pharmaceutical vial that, for the first time ever, allows for the risk of delamination to be determined based on threshold values.

SCHOTT monitors these values over the course of the manufacturing process and is thus able to minimize the risk of delamination.

The company succeeded in optimizing its manufacturing process to ensure that SCHOTT Vials DC have a more homogeneous surface, hence offering high chemical stability.

Furthermore, SCHOTT is the first manufacturer to develop a patented test method that even allows for this lower tendency to delamination to be documented - known as SCHOTT Delamination Quicktest. SCHOTT Vials DC will be available as 2R to 10R ISO vials starting at the beginning of 2014.

The problem of delamination, in other words the peeling off of flakes from the inner glass surface of a pharmaceutical vial as a result of interaction with the formulation and / or medication, has become increasingly important to the pharmaceutical industry in recent years.

Numerous recalls clearly confirm this, and the US drug authority in turn is explicitly requiring that pharmaceutical companies manage their risks more closely.

SCHOTT Vials DC thus represents an interesting solution for pharmaceutical companies interested in lowering the risk of delamination by selecting an improved packaging product. These vials are an interesting alternative not only for new products, but also for products that are already well established in the marketplace.

A more homogeneous surface thanks to a better production process
Dr. Bernhard Hladik, Head of Product Management, says that the mechanism behind delamination has been researched quite thoroughly and is well understood. “When the bottom of the vial is formed, volatile components like boron and sodium evaporate. They then go on to form inhomogeneous spots on the glass surface near the bottom of the vial that show a higher tendency to delaminate. With our new SCHOTT Vials DC, we have developed the production process even further to ensure that the glass surface is more homogeneous and thus less susceptible to delamination.”

To confirm this effect, SCHOTT conducted storage studies with systems that showed a high tendency to experience delamination while using standard Type I vials. The result: SCHOTT Vials DC remained stable even after six weeks of storage involving a 15% potassium chloride solution and a 10% sodium thiosulfate solution at a temperature of 60°C, while conventionally manufactured vials showed clear initial signs of delamination.

How the SCHOTT Delamination Quicktest works
SCHOTT is currently also the first manufacturer capable of determining the risk of delamination based on threshold values and then monitoring these values over the course of manufacturing. To achieve this, the company developed a Quicktest and had it patented. “In the past, the vials had to be examined carefully with a stereomicroscope during testing in order to be able to comment on delamination. For this reason, it was impossible to control the production process in a timely manner,” Hladik adds.

He describes the way in which the SCHOTT Delamination Quicktest works as follows: “A certain number of vials are removed from every batch. The random samples are then subjected to stress for four hours inside an autoclave in order to tease out the delamination critical zone. In a second step, the vials are filled with high purity water (WFI - Water for Injection) and sodium is extracted inside an autoclave. The volume of sodium extracted correlates with the probability that the vials will experience delamination at a later point in time.” By monitoring these values and adhering to certain threshold values, SCHOTT is now able to control the risk of delamination for the first time ever.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,100+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

SCHOTT Announces Major Expansion of Pharmaceutical Packaging Manufacturing in Russia
Capacity to expand by more than 50 percent / Consistent investment strategy helps customers achieve growth and quality objectives.
Monday, November 26, 2012
Scientific News
Developing a More Precise Seasonal Flu Vaccine
During the 2014-15 flu season, the poor match between the virus used to make the world’s vaccine stocks and the circulating seasonal virus yielded a vaccine that was less than 20 percent effective.
Fighting Cancer with Borrowed Immunity
A new step in cancer immunotherapy: researchers from the Netherlands Cancer Institute and University of Oslo/Oslo University Hospital show that even if one's own immune cells cannot recognize and fight their tumors, someone else's immune cells might.
Modified Microalgae Converts Sunlight into Valuable Medicine
A special type of microalgae can soon produce valuable chemicals such as cancer treatment drugs and much more just by harnessing energy from the sun.
Immune Cells Remember Their First Meal
Scientists at the University of Bristol have identified the trigger for immune cells' inflammatory response – a discovery that may pave the way for new treatments for many human diseases.
Paper Filter Can Remove Viruses from Water
A new paper filter can purify water from viruses, even the most difficult and contagious.
Large-scale HIV Vaccine Trial to Launch in South Africa
NIH-funded study will test safety, efficacy of vaccine regimen.
New HIV Vaccine Target Discovered
NIH-Led team have discovered a new vaccine target site on HIV.
Mimicking Evolution to Create Novel Proteins
A study by researchers in the Kuhlman lab offers a new route to design the 'cellular machines' needed to understand and battle diseases.
Antibody Therapy Opens Door to Potential New Treatment for HIV
Researchers at Rockefeller University show how a broadly neutralizing antibody could be used to help fight HIV.
Investigational Malaria Vaccine Protects Healthy U.S. Adults
Researchers at NIH have found that the malaria vaccine protected a small number of healthy, malaria-naïve adults in the U.S. from infection for more than one year after immunization.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!