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Large volume parenterals (LVPs) are terminally sterilized (autoclave) injectable aqueous drug products packaged in a single dose container, generally of 100 ml or larger (usually up to 1 liter).

 

The major ingredient of large volume parenterals is virtually always water and the active drug ingredients vary. Common ones include 5% to 50% dextrose, salts, albumin, dextran, and amino acids at varying percentages. Production batch sizes are usually very large, on the order of thousands of liters.

 

Water for product makeup and final rinse of containers and equipment must be USP Water for Injection, i.e. pyrogen free water meeting the standards of the monograph in the current version of the United States Pharmacopoeia.

 

Application of appropriate liquid filters in the manufacturing process of LVPs is numerous. They are used in the preparation of pharmaceutical grade waters for cleaning and product makeup, to final filtration for particulate and bioburden reduction immediately prior to filling and terminal sterilization. A typical pharmaceutical water system is illustrated in the attached flow schematic. Effective pharmaceutical grade depth filters in the early stages of the process can prevent fouling of downstream elements.

 

If necessary, removal of color emanating from raw materials is done by addition of activated carbon powder to the final bulk product. This requires preparation of the carbon, mixing, cleanup and filtration to remove the carbon from the product. As an alternative, use of carbon impregnated, fixed depth filter media provides standardization of carbon treatment and simultaneous particulate removal filtration. No separate steps are required pleated prefilters, sterilizing filters and the product itself. These include sanitary design lenticular format cartridges and housings and plate and frame filters, all incorporating validated pharmaceutical grade filter media.

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