Small Volume Parenteral

Small volume parenterals (SVP) include various traditional and bioengineered drugs. These drugs are usually packaged in small vials (less than 20 ml), pre-filled syringes and ampoules, or made in lyophilized powder. Lots of SVPs need aseptic processing for their lack of heat-stability.
Sterilizing filtration is used after synthesis or before filling. And it can add the sterility assurance if sterilizing filtration is used at both locations. Prefilters should be used to reduce bioburden and particles, which would clog final filters prematurely.

Separation Goals
● Prefiltration
Remove colloidal and particulate contaminants to extend the service life of downstream sterilizing filters
● Final filtration
Provide a sterile filtrate meeting the requirements of current regulatory

Application Requirements

● Final sterilizing filters should remove bacteria without altering the effects of drug products. Therefore, these filters should have low adsorption of active pharmaceutical ingredient (API), low extractables, be non-pyrogenic and integrity testable, and be sterile or can be sterilized.
● Prefilters and final filters should have enough flow rates. Final filters in the filling machine must have strong structures to prevent media flexing during pulsed flow filling processing, which will result in particle release, drips or other dispense problems.

Recommendation