How does a North American CDMO grow from a small legacy facility into a world-class medium-sized facility? We highlight an example in the case study attached. …more
Bosch Packaging Technology is pleased to announce its participation at the 2019 ISPE Aseptic Conference, to be held in North Bethesda, MA, on March 18-19, 2019, with podium presentations by US-based subject matter experts in both the aseptic and barrier education tracks of the program. …more
What is “Changeover Time”
ISPE Definition:
The time by which a processing area is cleared of supplies and components used in the manufacture of a previous product and then readied for production of a new product. This often includes parts change over and / or special cleaning to eliminate cross-contamination.
In other words:
Activities and the time needed between two batches …more
What exactly is behind “qualification and validation activities”?
What can Bosch Packaging Technology do for you?
Pharmaceutical manufacturing processes are becoming more complex and guidelines stricter. Accordingly, the focus in aseptic operations is of course protecting the aseptic interior of a barrier system against the environment and vice versa also protecting operators from highly potent pharmaceuticals. This requires suitable barrier technologies. One of the first steps is the categorization of the actual pharmaceutical product, followed by …more
