Sterility is the condition of being free from any viable organism. This is attained after carrying out sterilization, which is required for all compounded sterile products (CSPs). Effective sterilization of CSPs is among the key processes that must be proven effective through validation. The process should effectively inactivate viruses and destroy all microorganism without deteriorating the active ingredients and the designed dosage form.
The process of sterilization can be physical or chemical. Physical processes include moist heat, dry heat, irradiation and filtration. On the other hand, the use of gaseous or liquid sterilant is classified under chemical process. The first three physical methods and all chemical methods directly inactivate or kill viruses, bacteria and fungi. Filtration however, only removes microorganisms by separating them from the solution.