Large Volume Parenterals (LVPs) are single unit doses more than 100 cc. Prefiltration is used for removing particles to extend the service life of final (sterilizing) filtration. Final filters are used for reducing bioburden or sterile filtration prior to terminal sterilization. The volume of LVPs is usually tens of thousands of liters, and multiple filling lines may be working at the same time.
Ingredients in typical LVP solutions include water, dextrose (from 5% to 50%), amino acid, salts and very viscous total parenteral nutrition (TPN). Prefilters are used to reduce particles for salt solutions, and to remove hard particles for dextrose solutions before final sterilizing filtration (it’s another option to reduce bioburden by using 0.45 μm filters)
Separation Goals
● Prefiltration
Remove colloidal and particulate contaminants to extend the service life of downstream sterilizing filters
●Final filtration
Reduce bioburden prior to terminal sterilization (0.45 μm)
Sterile filtration prior to terminal sterilization (0.22 μm)
Application Requirements
●LVP filters must provide consistent high flow rates to ensure the accuracy and consistency of filling.
●Since typical LVP filling process is operated under high differential pressure and high flow rates, filters must have superior mechanical strength and be reliable and robust.
●The cost of LVP filters must be economical.
●Prefilters and sterilizing filters must bear multiple cycles of steam-in-place sterilization or hot water sanitization.
Recommendation