Drinking water is the basis for producing water for pharmaceutical purposes in all national pharmacopoeias. What was long prohibited in the EU has been a reality for the past two years. …more
There are many things to consider when transferring products and materials into barrier systems. It begins with categorizing the pharmaceutical product and defining the aseptic environment. How is my product categorized? What processes and procedures are commonly used? Which room classifications are available? These and many other questions are a first baseline to start with.
Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating and reviewing risks that affect the quality of a medicinal product. An efficiently implemented quality risk management system (QRM) ensures the quality of products throughout the entire life cycles and is an enabler of the Pharmaceutical Quality System (PQS). …more
(Russian Version below)
At Pharmtech in Moscow, visitors to booth B6021 (pavillion 2, hall 8) are in for a local premiere, some exciting action, an inspiring talk, as well as a few new and familiar faces.
Mission accomplished – How automating the packaging process enables pharmaceutical contract manufacturer to increase production and flexibility. …more
Today, the processing of highly potent pharmaceuticals is becoming increasingly important. However, this is not the only trend that has an impact on the pharmaceutical industry. In this interview, Matthias Angelmaier, global product manager for barrier systems and isolator technology, not only gives answers to current trends and development opportunities, but also provides exciting insights behind the scenes of a product manager.
Which implications will EU GMP Annex 1 have for sterile fill/finish processes? How will it change the way we work in the pharmaceutical industry? And which technologies are best suited? …more
Inspection is a very challenging stage in the pharmaceutical manufacturing process. This is especially true for products with difficult characteristics, such as highly viscous parenteral solutions where air bubbles cannot be completely eliminated and their differentiation from particles is problematic. …more
Since every liquid pharmaceutical is different, a number of aspects need to be considered when it comes to pharmaceutical filling. How do the individual parameters determine the selection of the ideal filling system? …more
Bosch Packaging Technology and bio pharmaceutical leader AbbVie set new standards in aseptic high-potent filling lines. …more
