Large volumes of parenteral drugs (LVP) is a single package of more than 100 ml. Usually the size of lots reaches 10 000 of liters and more. The main ingredients in typical solutions of LVP are water, glucose, salts, amino acids, viscous components.
- The filter cartridges for LVP must provide high flow rates.
- Filter cartridges for LVP should have excellent mechanical strength, due to the bottling process takes place at high differential pressure drop and flow rates.
- The process requires high economic efficiency, therefore the filter cartridges must have a good resource due to a large surface area, instantly wetted, and have a low initial hydraulic resistance.
- The final membrane filters should have a low level of extractable substances, do not release pyrogens, successfully pass the integrity test.
- Prefilters and sterilizing filters must withstand multiple cycles of sterilization (steam-in-line, autoclaving) or sanitary treatment with hot water.
The LVP filtration scheme typically includes a pre-filtration stage using a depth filter to reduce the amount of contaminants and a sterilizing filtration stage using a membrane filter (sometimes a 3-stage cascade scheme including a 0.45 μm membrane filter is used to decrease the bioburden before the sterilizing filter with 0,2 μm micron rating).
Without a prefilter, the membrane is clogged quickly, so the throughput of the filter system is reduced. The use of a depth filter as a prefilter allows to increase the resource of the system. The coordinated combination of the final filter and prefilter provides the required flow rate and all process requirements.
Purposes of filtration
- to extend the life of the final sterilizing filters by removing colloidal and mechanical impurities
- to reduce the bioburden (filtration with micron rating 0.45 μm)
- sterilizing filtration before heat treatment (filtration with micron rating 0.2 μm)
Recommendations for filter cartridges
We recommend membrane depth prefilters EPVg.P, EPV.SC or EPV.S.
The filter cartridges of these series are capable of providing high flow rates, excellent mechanical and thermal resistance, high efficiency of microparticle retention, do not emit fibers into the filtrate, manufactured according to ISO 9001: 2000.
We recommend membrane filter cartridges EPM.PS or EPM.K.
Depending on the types of fluids, we recommend sterilizing membrane filter cartridges EPM.PS based on a high-performance asymmetric polyethersulfone membrane PES (for LVP with a high concentration of soluble substances, for example glucose from 5 to 50 %, for solutions with viscous components, such as Complete Infusion Nutrition) and membrane filter cartridges EPM.K based on polyamide (eg , for saline solutions with a low concentration of soluble substances) with a pore size of 0.45 μm to reduce the bioburden and 0.2 μm for sterilizing filtration.
Sterilizing air filtration ("breathing" filters):
We recommend membrane filter cartridges made of polytetrafluoroethylene EPM.F4 with 0.2 μm pore size.
We recommend filter housing DS-1-D(-/-)M – sanitary construction.
For the organization of the filtration process we propose the body equipment - the filter housing of the series DS sanitary construction made from high-quality steel AISI 316L or AISI 304.
Device for monitoring the integrity of membrane filtration systems - TECHNOCHEK.
For the final choice of the scheme for large volume of parenteral drugs (LVP) filtration, please contact specialists of NPP “Technofilter”.