Biomedical Engineering Reference
In-Depth Information
Figure
10.4.
Detailed unit operations in Focus Area 3: Compounding.
Identification of Process Parameters.
A process parameter is defined as
a process input. These are typically machines, materials, measurements, processes,
people, and environments. In our case study for FA3, compounding process parameters
identified include: mixing speed, mixing time, hold time, temperature, excipient quality,
excipient handling, balance accuracy, and operator training. These are outlined in the risk
assessment sheet in Table 10.1.
For fill and finish activities (FA5), the process parameters would include filling
speed, needle bore size, needle height, vial size, fill volume, temperature, and line speed
along with people and environment-related parameters.
Identification of Quality Attributes.
A quality attribute is defined as a process
output. Quality attributes are typically physical, chemical, or microbiological properties
