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Industry Applications

Small Volume Injections

Large volume parenteral solutions typically have unit doses exceeding 100 milliliters. Prefiltration is used to remove particles and extend the lifespan of the terminal (sterilizing) filter. The terminal filter is used to reduce the bioburden or remove bacteria from the solution before final sterilization. Batches of large volume parenteral solutions often exceed tens of thousands of liters and may involve multiple filling lines operating simultaneously.

The composition of large volume parenteral solutions includes water, glucose (5% to 50%), amino acids, salts, and total parenteral nutrition (TPN) solutions with high viscosity. Prefiltration of saline solutions aims to reduce particles in the solution, while prefiltration of glucose solutions is typically used to remove hard particles before final 0.22 μm sterilizing filtration (using a 0.45 μm filter to reduce bioburden is also an option).

Purpose of Separation

● Prefiltration

To remove colloids and particles, extending the lifespan of downstream sterilizing filters.

● Terminal Filtration

To reduce bioburden (0.45 μm) before final sterilization.

To sterilize (0.22 μm) before final sterilization.

Application Requirements

● Filters for large volume parenteral solutions must provide stable high flow rates to ensure accurate and consistent filling.

● The filling process for large volume parenteral solutions often occurs under high pressure differentials and flow rates, requiring filters with excellent mechanical strength, reliability, and durability.

● The cost of filters used for large volume parenteral solutions should not be excessive.

● Both prefilters and sterilizing filters must be able to withstand repeated steam sterilization or hot water sanitization.