Page 31 - Pharmaceutics IV (02-06-01305)
P. 31
Pharmaceutical requirements Sterility
Before manufacture
• Raw materials may be exposed to radiation or ethylene oxide for this
purpose.
• Filtration should be employed to reduce the bioburden in water.
55
Pharmaceutical requirements Sterility
During manufacture
Use of special aseptic technique during manufacture that minimizes
the possibility of contamination from human or extraneous material:
• Manufacturing area is maintained bacteria-free by:
➢ Use of ultraviolet lights and a HEPA (high efficiency particulate
air) filtered air supply
➢ The disinfectant solutions are filter sterilized because they may,
themselves, be a source of contamination with resistant organisms.
56 28
Salma E. EL-Habashy
