Application Note

CCIT Solutions For The Pharmaceutical Industry

CCIT Solutions

The quality and effectiveness of drugs significantly depends on their proper packaging: Sterile products and moisture/oxygen sensitive drugs require excellent barrier during the shelf life of the product (up to a couple of years) to protect them from biological contamination, water and oxygen ingress. Otherwise, serious consequences might occur. This was proven by a grave incident in the 1970's: During this period, contaminated intravenous fluids pack-aged in glass bottles – which were typical at the time for packaging such dosage forms – caused an estimated 2,000 to 8,000 episodes of bloodstream infection, resulting in the deaths of about 10 % of the patients. This severe package-integrity failure incident has triggered a heightened awareness of package integrity in the life science industry.

The key risks for contamination are by humidity, oxygen or microbiological ingress, which can impact the drug stability throughout the product life cycle. To prevent the risks of stability failure of highly moisture sensitive drugs (e.g. dry powder for inhalation) or the risk of biological ingress of sterile parenteral drugs, integrity tests with a high sensitivity are required.

Pfeiffer Vacuum offers a wide range of different leak testing methods to address the multitude of challenges within the pharmaceutical industry as there is no one solution that fits all different challenges connected to a specific product.

VIEW THE APPLICATION NOTE!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.

Subscribe to Pharmaceutical Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Pharmaceutical Online