RU | EN
contact phone +7 (4922) 47-47-41
About Us Production Application Quality Training and Service News Contact Feedback

Filtration of parenteral preparations of large volumes (LVP)

Home - Application - Biopharmaceuticals and medicine - Filtration of parenteral preparations of large volumes (LVP)

Filling parenteral preparations of large volumes (LVP) is a single package of more than 100 ml. Usually the size of lots reaches tens of thousands of liters. The main ingredients in typical solutions of LVP are water, glucose, salts, amino acids, viscous components.

 

 

Process Requirements

 

The filter elements for LVP must provide constant high flow rates.

 

Filter elements should have excellent mechanical strength, because The bottling process takes place at high differential pressures and flow rates.

 

The process requires high economic efficiency, therefore the filter elements 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, subject to the integrity test.

 

Prefilters and sterilizing filters must withstand multiple cycles of sterilization (line steam, autoclaving) or sanitary treatment with hot water.

 

The LVP filtration scheme typically includes a pre-filtration stage through a depth filter to reduce the amount of contaminants and a sterilizing filtration step using a membrane filter (sometimes a 3-stage cascade scheme including a 0.45 μm membrane filter is used to lower the bioburden before the sterilizing filter 0, 2 μm).

 

In the absence of a pre-filter, the membrane is clogged quickly, resulting in a reduction in the throughput of the filter system. The use of a deep filter as a preliminary allows a much larger 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

 

 

Prefiltration

 

To extend the life of the final sterilizing filters by removing colloidal and mechanical impurities

 

Finishing filtration

 

reduce the biological load (0.45 μm)

 

Sterilizing filtration before heat treatment (0.2 μm)

 

Filter recommendations Technofilter for LVP filtering process

 

Depending on the specific processing steps and types of fluids, we recommend that for qualitative prefiltration that meets the requirements of the process, use the  deep pre-filters  EPVg.p, EPVS, EPVS. The filter elements of these series are capable of providing high flow rates, excellent mechanical and thermal resistance, low resistance, high efficiency of microparticle retention, do not emit fibers into the filtrate, manufactured according to ISO 9001: 2000.

 

For the final filtration, depending on the types of fluids, we recommend  sterilizing membrane filters EHMP based on a high-performance asymmetric polyethersulfone membrane (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  EPMA 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.

 

For sterilizing air filtration ("breathing" filters), we recommend membrane filter elements made of  polytetrafluoroethylene EF.F4 with 0.2 μm pore size.

 

For the organization of the filtration process we propose the body equipment - medical   the filter holders of the DS series from high-quality steel AISI 316L or AISI 304 (12Х18Н10Т) for different number and height of the filter elements and filtration plants based on them.

 

Device for monitoring the integrity of membrane filtration systems -  TECHNOCHEK.

 

For the final choice of the scheme for the filtration process for parenteral LVP preparations, please contact specialists of Technofilter LLC.


Back to top