Articles

Terminal sterilization of aseptically processed drug products is extremely important for patient safety. As such, it is a regulatory requirement that drug products that can withstand terminal sterilization be terminally sterilized. Overkill type sterilization cycles are not required for a drug manufacturer to make a terminal sterilization claim. Many different time and temperature combinations that are much more product friendly can be used to safely terminally sterilize drug products.

Terminal Sterilization of Sterile Filtered Products

Cationic Adsorbent Gel Raft formulation for use in proton pump inhibited stomach.   Concept proven with fiberoptic UV probes eliminating the need for HPLC analysis. 

Delayed Binding of Bile Salts by Matrix Bound Cationic Adsorbents Dispersed in Alginate Rafts

This whitepaper deals with the sterilization of prefilled syringes and describes which requirements must be considered regarding products and methods as well as how risks can be avoided effectively.

Terminal sterilization of prefilled syringes

Delivery of robust E&L programs by leveraging Agile software development methodologies in the laboratory.

Embracing Agile Methodology for E&L Excellence

This case study highlights the benefits of a pre-fabricated modular construction approach using autonomous cleanrooms in support of the accelerated delivery of a COVID vaccine manufacturing facility. 

Accelerated Delivery of COVID Vaccine Facilities

In the highly regulated life sciences industry, effective change control is essential to your success. Our white paper “Managing change Control to Comply With FDA and EU Regulations” will show you how you can improve change control speed, efficiency, and compliance.


Managing Change Control Alongside Evolving Regulations

The update for EU annex 1 is more than a simple revision, solidifying the expectation that facility fully understand their processes and systems.  


Operational Impact of Annex 1 Update v2

This case study shows the results after implementing a continuous monitoring of product interface temperature, using a new non-invasive technique, during the lyophilization process.

Freeze-drying: non-invasive product temperature monitoring 

Using AI for CAPA and Root Cause Investigation

This application note demonstrates how to develop a single method with direct detection of choline salts and impurities without the need for derivatization.

All Whitepapers