Filtration of parenteral preparations

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Filtration of drugs for parenteral use, ophthalmic solutions, clarification of biological and pharmaceutical fluids in a wide range of pH.

Filtration of drugs is carried out in multi-stage (cascade) filtering mode. With proper distribution of the load of the mud, the particles are most effectively retained by the cleaning (sterilizing) filter. The pre-filter must be capable of repeated regeneration and ensure a high service life of the entire system.

Mud load distribution in cascade filtering mode

 

Filtering elements from various filtering materials can be used to pre-filter drugs. A special condition is the inertness and neutrality of the filtering materials, that is, the filter should not allocate anything to the filtrate and at the same time remain unchanged. Filter elements made of fluoroplast-4 and ultrahigh molecular weight polyethylene have almost absolute chemical resistance, which makes their use in many cases justified, especially when it comes to filtering pharmaceutical products that represent a chemically aggressive environment.

Filter elements for filtering drugs:

Fluoroplast-4 Ecoplast-F elements for deep filtration

Used for pre-filtering preparations for parenteral use, aqueous and aqueous solutions, herbal preparations, as well as aggressive liquids in a wide range of pH, including at high temperatures.

• filtration rating from 0.2 to 10 microns;
• Particle retention efficiency – 99%;
• Operating temperature – from -30 to 170°C;
• Chemically inert when filtering any mineral and organic compounds;
• To be chemically regenerated and backwashed when the pressure drops to 6   atm

Ultrathin molecular polyethylene depth filter elements  
ECOPLAST-PE

Used for pre-filtration of parenteral preparations, ophthalmic solutions, herbal preparations, syrups and other biological and pharmaceutical fluids, including viscous. In some cases, polyethylene filter elements are the best solution in terms of price/quality ratio, especially for pre-filtration preparations with increased viscosity, for example, 20% or 40% glucose solution, solutions with methylcellulose content, etc.

• Filtered rating 1-50   um;
• Particle retention efficiency – 98-99%;
• Operating temperature – from -30 to 100°C;
• Chemically inert when filtering most mineral and organic compounds;
• It is subject to chemical regeneration and backwashing when the pressure drops to 6 atm;
• High work resource.

The use of PTFE-4 depth elements and polyethylene for the production of infusion and injection preparations is confirmed by entering them into the State Register of Medical Products as a filter kit for pharmaceutical preparations KFA.

Filter elements with a fluoroplastic-4 EKOPLEN-F membrane

Used for pre-filtering preparations for parenteral use, aqueous and aqueous solutions, herbal preparations, as well as aggressive liquids in a wide range of pH, including at high temperatures. ECOPLEN-F elements provide a high degree of protection for finishing filters, have a long service life with the possibility of carrying out chemical regenerations using acid or alkaline solutions, including concentrated, unlimited number of sterilization cycles in line with live steam at 134°C.

• Filtration rating of 0.5-5 microns;
• Particle retention efficiency – 99.9%;
• Water capacity from 5 to 17 m3/h with a pressure drop of 1 atm;
• Operating temperature up to 130°C;
• The sterilization temperature is 134°C for an unlimited number of cycles.

Corrugated film filter elements based on polypropylene film ECOPLEN-PP

Used for coarse and fine purification of water and aqueous solutions, parenteral preparations, clarifying filtration of culture media, biological fluids, herbal preparations, etc.

• Filtration rating from 1 to 10   μm;
• High work resource;
• The ability to regenerate multiple times;
• Operating temperature up to 100°C.

Membrane filter elements of the brand ECOPOR-PA based on a polyamide membrane and the brand ECOPOR-F42 based on hydrophilic fluoroplast-42.

Used for fine filtration of injection and infusion preparations, culture, bacterial and enzymatic media, ophthalmic preparations, blood serum, protein, vitamin and galenic preparations, vaccines and antibiotics.

• Particle retention efficiency – 99.996%;
• Operating temperature – from 0 to 70°C;
• Elements are subject to sanitary and chemical treatment in accordance with MU-287-113. Sterilization – in an autoclave at T = 121°C and P = 0.11   MPa.

Sorption-filtering elements with filling of pulverized activated carbon of the EKOSORB brand for the treatment of substances and solutions:

• Use of activated carbon grades traditionally used to treat drugs;
• Maximum sorption efficiency due to maximum dispersion of coal;
• Ensuring microbiological purity of the filtrate through the use of a fluoroplast-4 membrane as internal drainage;
• Autonomy of use (do not require additional filtering).

Filter housings:

Obninsk Filters Group manufactures filter housings made of stainless steel AISI 316L, providing performance from 100 l/h to 10 m3/h.

• Filter housings are made in the medical version, with electro-polishing;
• Due to the one-piece construction of the base of the filter housing, the number of welds is minimized, all surfaces of the filter housing can be easily processed and polished.

Filtration problems solved by Obninsk Filters Group in the pharmaceutical industry:

• Purification of pyrogen-free water in the ampoule and flacon washing machines imported and domestically produced, purification of recycled water on washing machines;
• Fine cleaning of steam used for heating reactor boilers, steaming tanks, steam condensation washing, etc .;
• Purification of process air (up to sterility) at the points of using solutions, drying ampoules and vials;
• Water deironing (incl. hot), water purification at some stages of water treatment;
• Purification of products of biological synthesis, serum;
• Clarification of carbon-containing solutions.