Small-volume parenteral (SVP) injection
Published Time:
2025-02-05
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Small-volume parenterals (SVPs) encompass a variety of conventional and bioengineered drugs. These drugs are typically packaged in vials (less than 20ml), pre-filled syringes, and ampoules, or are formulated as lyophilized powders. Many SVPs require sterility
Because they lack thermal stability.
Sterile filtration is used post-synthesis or pre-filling. If sterilization filtration is used at both locations, it can increase sterility assurance. Pre-filters should be used to reduce bioburden and particulates, which would prematurely clog the final filter.
Separation Target
● Pre-filtration
Removes colloidal and particulate contaminants, extending the life of the downstream sterilizing filter
● Final filtration
Provides a sterile filtrate that meets current regulatory requirements
Application Conditions
● The final sterilizing filter should remove bacteria without altering the drug's efficacy. Therefore, these filters should have low active pharmaceutical ingredient (API) adsorption, low extractables, be pyrogen-free, integrity testable, and should be sterile or sterilizable.
● Pre-filters and final filters should have sufficient flow rates. Final filters in cassettes must have a robust structure to prevent media bending during pulsatile flow filling processes, which would lead to particulate release, shedding, or other dispensing issues.
Recommendation
| Filtration Steps | Recommendation |
| Pre-filtration | PP,NN |
| Sterile Venting | PTFE |
| Final filtration | PES |
Eye drop filtration solution
Large-volume injection process
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