We had grown very quickly and acquired several companies, and the F.D.A. was questioning whether our manufacturing controls were sufficient.
In those years, engineers argued that efficiency and productivity were things that could be measured and managed, and, if you had the right inventory and manufacturing controls in place, no widget would be left behind.
The need for more precise manufacturing controls fits well with VRLA needs and requirements.
It has been noted that these compounding practices, despite best efforts and intentions, do not incorporate the necessary manufacturing controls to assure reproducible product potency, stability, and purity.
Depending on the device type, the use of additive manufacturing may present additional technical challenges in terms of manufacturing controls, device performance, biocompatibility and sterilization, etc.
The long beam path and low energy beam demands the tight tolerances on each of these mechanical features and therefore demands the high degree of manufacturing controls on each of the processes.
