Demand for personalised medicines containing HPAPIs (High Potent Active Pharmaceutical Ingredients) combined with shorter turnaround times is forcing pharmaceutical process manufacturers to develop faster, more agile ways of working. This is especially true for those with newer super-potent oncology, cardiovascular and diabetes medicines, and where a GMP compliant environment is essential.
It’s easy to forget that the people developing, manufacturing and dispensing these drugs are in danger of being exposed to harmful, sometimes deadly, chemical compounds. Yet their work is essential to the steady supply of ever more complex medicines that keep many of us healthy.
We have specialist expertise in helping CMOs and CDMOs handle HPAPIs safely within their existing non-contained manufacturing process. We design, manufacture and install single-use flexible isolator systems to achieve containment performance levels below 1μ/m3(OEB 5). These are bespoke to the site and each process, from weighing, mixing, milling, spray drying to packaging.
Why choose a flexible system?
A key driver in more agile working processes, is the need to reduce cleaning and cleaning validation costs, as well as avoiding large capital expenditure. If you can encapsulate a process within a flexible isolator, you can reduce that cost significantly or in some instances, eliminate it altogether. Over the years, we've learnt that we are able to retrofit around 98% of all existing process equipment.
Flexible isolator technology arguably also offers a better solution to contract manufacturers, simply due to how adaptable it is. It allows for simple engineering change out and has been shown to improve productivity - more batches can be carried out due to less downtime.
A flexible isolator can be used for a number of months and when no longer needed, put away for storage after the single-use glove bags have been safely disposed of. If you win another urgent project requiring high containment, then the system can be rolled out again, keeping the original frame and control system and needing just a new glove bag and HEPA filtration.