James Finn describes the development of the IChemE award-winning setup for sterile filtration of APIs for The Chemical Engineer.
When you are dealing with the manufacture of an intravenous pharmaceutical product, sterility is key. A vital stage in ensuring this is the sterile filtration of bulk APIs (active pharmaceutical ingredients) and excipients (prior to their introduction into a sterile process train) to remove bacteria, micro-organisms and particulates which may be harmful to the patient. This is typically achieved using a filter with a nominal pore size of 0.22 µm.
When you are dealing with an antibiotic that is also on the World Health Organization’s List of Essential Medicines, being able to guarantee and prove that sterility, allowing for expeditious release of the final product, is vital to maintaining supply to critically ill patients.
Read more on The Chemical Engineer: https://www.thechemicalengineer.com/features/a-clean-bill-of-health/