Isolation of aseptic processes is not a new technology. Rigid stainless-steel isolators have been available...
Parenteral preparations are solutions, suspensions, emulsions for injection or infusion, powders for injection for infusion, and gels for injection and implants intended to be administered into the systemic circulation in humans or animals.
They are required, like any pharmaceutical dosage form, to meet pharmaceutical quality standards as described in pharmacopeias and to be safe for the intended purpose of use.
In addition, to be sterile perenteral preparations must be pyrogen-free. Sterility can be achieved by different processes of sterilisation, which should be appropriate to the formulations. The pyrogen-free aspect will require, if no depyrogenation process is used during the preparation of the sterile drug products, the use of pharmaceutical ingredients, drug substances or active pharmaceutical ingredients (API) and excipients.
Download to find out more