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Filtration industry overview: World pharma and biotechnology market 2008
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Feature
Filtration+Separation October 2008
Filtration industry overview:
World pharma and biotechnology market 2008 T
his article addresses the markets, technologies and processes surrounding filtration methods in these two important industries, focusing on fluid and water filtration.
Cleanliness and avoidance of contamination are critically important factors in the pharmaceutical and biotech industries because many of the products are eventually consumed by humans. The US EPA recognises four distinct subcategories within the pharmaceutical manufacturing industry: Subcategory A (Fermentation); Subcategory B (Extraction); Subcategory C (Chemical Synthesis); and Subcategory D (Mixing, Compounding, and Formulating). By the nature of the manufacturing operations, it is to be expected that the majority of the pollutants discharged are non-toxic in the amounts discharged. For Subcategory D operations, the use of food grade (or FDA approved) materials is emphasised, which implies limited toxicity of the potential waste products. However, the industry is still required to meet conventional wastewater treatment limits, which may have little relationship to the chemistry of its individual wastewater components.
not contain pyrogens. Because of its low ion content, WFI must be made isotonic before injection. Isotonic solutions are those that have the same salt concentration as blood. Sterile water for injection meets all of the above requirements but must also be free of any microbial agent or any chemical additive and must be produced so that it is sterile. In order to achieve the various levels of required cleanliness, different technologies are used. Reverse osmosis, ultrafiltration, microfiltration, cartridges, and macro filtration processes such as filter presses, sedimentation and centrifugation are all utilised. The market size and brief summary of each method will be described.
Reverse Osmosis/ Ultrafiltration/ Microfiltration Reverse Osmosis, Ultrafiltration, and Microfiltration (RO, UF, and MF) technologies are cross flow membrane systems
used in the pharmaceutical and biotechnology industry to purify the water used in the processes and also wastewater, either for discharge to waterways or for reclamation. One of the largest uses of crossflow membrane technology in this segment is in process separations. Purification of water for injection into patients (WFI) is another major application. The complete range of RO, UF, and MF systems are employed. Microfiltration (MF) is a membrane filtration process allowing molecules of the size of salts, sugars, and proteins to pass through the membrane pores, while molecules of the size of bacteria are rejected. MF is commonly used to sterilise liquid reagents such as cell culture media. Microfiltration can also be used as pretreatment to reverse osmosis. The MF equipment and membrane markets hold the largest market share of the three processes, at over $300 million and $123 million respectively for 2008.
Filtration applications include water for injection (WFI), container washing, processing including drying and separation to formulate tablets or broth, and wastewater treatment. There are several levels of severity in the water requirements for pharmaceutical and biotech applications. First, there is purified water in its general form. It must meet requirements for chemical and bacteriological purity, but is not intended for parenteral use. Water for injection (WFI) has to meet more stringent requirements. It must meet all of the above requirements but does not necessarily need to be sterile, however, it must
Figure 1: The 2008 market share for reverse osmosis, ultrafiltration and microfiltration.
Feature
Filtration+Separation October 2008
RO, MF and UF will see continued growth at about 9 percent per year for the next few years. Figure 1 shows the market share of each process for 2008.
Cartridge filters Cartridge filtration is the technology most in use in the pharmaceutical and biotechnology industries, holding a total market size of over $2 billion for these industries.
Figure 2: The 2008 market share for each type of cartridge filter.
Cartridge filters are normally used for fluid polishing, with particle size to be separated smaller than about 50 microns. Surface filtration takes place in pleated filters while depth filtration is the mechanism in string wound, resin impregnated and molded cartridges. Depth filters have traditionally had a lower cost than surface filters. Cartridge filters are typically installed prior to the RO units. Cartridge filter types include membrane, nonwoven, carbon, string wound and metal. Membrane cartridge filters are ideal for the critical filtration needed in pharmaceutical and biotech manufacturing, hence having the largest market share at over $1 billion for 2008. Membrane filter materials include nylon, polypropylene, and PTFE.
Figure 3: The 2008 market share of macro filtration products.
Cartridge filtration is the widest used technology in the pharmaceutical and biotech industries, followed by reverse osmosis, ultrafiltration and microfiltration systems. The next largest market segment is for nonwoven cartridges, at $769 million. Nonwoven cartridges are used as a support layer for membranes, as well as on their own for less critical filtration applications. Carbon filters, used to achieve organic purity, hold a market share of $137 million. Metal and string wound segments are smaller, at $77 million and almost $48 million respectively. Figure 2 shows the market share by cartridge type for 2008.
Figure 4: The market share for sedimentation and centrifugation.
Reverse osmosis produces the finest level of filtration of all the membrane processes. Application of RO most often is to provide water which is almost free of solids, salts, organics and colloids to subsequent final polishing processes, such as ion exchange. The reverse osmosis equipment market for 2008 is close to $135 million, with the RO membrane market at almost $73 million.
The ultrafiltration process typically rejects organics over 1,000 molecular weight (MW) while passing ions and small organics. In the pharmaceutical industry, it is being used as a final filter in some pharmaceutical water purification systems. In 2008, the ultrafiltration equipment market is $241 million, and the membrane market is over $105 million.
Macro filtration Macro filtration, also known as liquid filtration, is characterised by particle removal between l and 100 micrometers in diameter. This segment includes leaf filters, bag filters and filter presses. A filter press is used for solid-liquid separation of pharmaceutical solutions. The solution to be filtered is made to pass through a thin membrane until the solid material is split from the liquid.
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Filtration+Separation October 2008
The pharmaceutical industry is one of the smaller segments, but it is the highest growth segment. This is in part due to the critical role that disk separators play in the production of biotechnology products. The total world market in the pharmaceutical/ biotech industry for sedimentation & centrifugation products in 2008 is $325 million. Figure 4 shows the disk separators market for 2008 is the largest segment, at $115 million, followed by basket centrifuges at almost $108 million.
Ultrapure Water Systems New applications, new technology and new ways to operate are providing dynamic change to the ultrapure water industry. Power plants were early users of the technology. The semiconductor and pharmaceutical industries have been the biggest recent investors. Figure 5: 2008 market shares by filtration type.
These specialised equipments are also used to remove suspended particles from a solution and process water and wastewater treatment. Automatic pressure filters are designed for foods, pharmaceuticals and solvent-wetted products. Some features allow double-sided filtration for multiple cake washing and cake drying options. Automatic pressure filters can be seen in penicillin production to help increase recovery of the penicillinactive ingredient. The process involves making a fermentation, which contains the penicillin, and solid mycelia waste. The solids and the liquids are separated, and the liquid is extracted with solvents to remove the penicillin. The manufacturer can separate the solids and liquids in rotary drum vacuum filters, and dispose of the mycelia in the wastewater, but the vacuum filters can produce a fairly wet cake containing a significant amount of penicillin, which is lost. Replacing the vacuum filters with automatic pressure filters will give it a drier filter cake and clearer filtrate, as well as lower penicillin loss. Leaf filters employ a nest of filter discs spaced on a common shaft and fully enclosed within a pressure-resistant casing. Overall configuration may be vertical or horizontal. The filter nest is normally static for filtration, the suspension being passed through the nest under positive or negative (vacuum) pressure. Filtrate is withdrawn separately, with solids remaining on the filter disks as cake. Leaf design varies widely, from simple to complex mesh forms, with or without filter cloths fitted, and for use with or without precoat. A precoat is normally employed where fine filtering is required. Particular advantages of vertical leaf filters are good cake consistency with freedom from cracking or channeling
because the filter cake is not affected by pressure variations. Bag filters are widely used for the capture of solids and purification of liquids. The solid retaining capacity gives them advantages over cartridges. A wide variety of media can be selected for bag filter applications including rayon viscose, polypropylene, polyester and nylon. Bag filter vessels can be furnished in a variety of corrosion resistant alloys as well as carbon, steel and FRP.
The pharmaceutical purchases of ultrapure water systems (UPW) continue to grow at a steady rate of 6 percent to 7 percent per year and will exceed $267 million worldwide in 2008 and $345 million per year by 2012. Within this sector, biotech is growing much faster than the total pharmaceutical UPW market, with strong growth especially in India. A summary of the market shares by technology are illustrated in Figure 5. Cartridge filtration is the widest used technology in the pharmaceutical and biotech industries, followed by RO/UF/MF systems.
Cartridge filtration is the technology most in use in Disposable process equipment – a the pharmaceutical and growing trend biotechnology industries, holding Disposable process equipment is a fast a total market size of over $2 growing industry trend, as drug manufacturers billion for these industries. adopt single-use systems to reduce cleaning, Leaf, tubular and belt filtration holds a large market share of the macro filtration systems for the pharmaceutical and biotech industries. New equipment for these devices is near $108 million, with the media used at almost $44 million. The next largest segment in 2008 is bag filters, at $52 million for new equipment and $53 million for the bags. The 2008 market for macro filtration products is shown in Figure 3.
Sedimentation and centrifugation Separators used in the production and processing of, for example, human blood, vaccines, bacteria, algae and pigments, must meet stringent requirements. In certain situations, the process must run under sterile conditions, be fully automated and ensure economy and efficiency. Designs include a suspended bowl concept, completely segregated process and drive areas, and fully automatic operation to provide the sterile treatment of the product with highest possible efficiency.
sterilisation and their associated validation costs. According to single use system manufacturer Pall, disposables are in use over 90 percent of pharmaceutical and biotechnology companies’ manufacturing processes. Pall states that the systems reduce possibilities for FDA noncompliance, and also enable faster, more cost effective product changeovers. However, some drug makers who haven’t made the switch to disposables are concerned about the plastic materials leaching into product or contaminating solvent, and want to avoid getting locked into one source of the materials. To address these concerns, single use manufacturers have created The BioProcess Systems Alliance (BPSA), an industry organisation to promote single-use technology worldwide through education, industry guides, and support of standards development.
•
Contact: Karen Vacura Email: [email protected] McIlvaine Company
Feature
Filtration+Separation October 2008
Filtration industry overview:
World pharma and biotechnology market 2008 T
his article addresses the markets, technologies and processes surrounding filtration methods in these two important industries, focusing on fluid and water filtration.
Cleanliness and avoidance of contamination are critically important factors in the pharmaceutical and biotech industries because many of the products are eventually consumed by humans. The US EPA recognises four distinct subcategories within the pharmaceutical manufacturing industry: Subcategory A (Fermentation); Subcategory B (Extraction); Subcategory C (Chemical Synthesis); and Subcategory D (Mixing, Compounding, and Formulating). By the nature of the manufacturing operations, it is to be expected that the majority of the pollutants discharged are non-toxic in the amounts discharged. For Subcategory D operations, the use of food grade (or FDA approved) materials is emphasised, which implies limited toxicity of the potential waste products. However, the industry is still required to meet conventional wastewater treatment limits, which may have little relationship to the chemistry of its individual wastewater components.
not contain pyrogens. Because of its low ion content, WFI must be made isotonic before injection. Isotonic solutions are those that have the same salt concentration as blood. Sterile water for injection meets all of the above requirements but must also be free of any microbial agent or any chemical additive and must be produced so that it is sterile. In order to achieve the various levels of required cleanliness, different technologies are used. Reverse osmosis, ultrafiltration, microfiltration, cartridges, and macro filtration processes such as filter presses, sedimentation and centrifugation are all utilised. The market size and brief summary of each method will be described.
Reverse Osmosis/ Ultrafiltration/ Microfiltration Reverse Osmosis, Ultrafiltration, and Microfiltration (RO, UF, and MF) technologies are cross flow membrane systems
used in the pharmaceutical and biotechnology industry to purify the water used in the processes and also wastewater, either for discharge to waterways or for reclamation. One of the largest uses of crossflow membrane technology in this segment is in process separations. Purification of water for injection into patients (WFI) is another major application. The complete range of RO, UF, and MF systems are employed. Microfiltration (MF) is a membrane filtration process allowing molecules of the size of salts, sugars, and proteins to pass through the membrane pores, while molecules of the size of bacteria are rejected. MF is commonly used to sterilise liquid reagents such as cell culture media. Microfiltration can also be used as pretreatment to reverse osmosis. The MF equipment and membrane markets hold the largest market share of the three processes, at over $300 million and $123 million respectively for 2008.
Filtration applications include water for injection (WFI), container washing, processing including drying and separation to formulate tablets or broth, and wastewater treatment. There are several levels of severity in the water requirements for pharmaceutical and biotech applications. First, there is purified water in its general form. It must meet requirements for chemical and bacteriological purity, but is not intended for parenteral use. Water for injection (WFI) has to meet more stringent requirements. It must meet all of the above requirements but does not necessarily need to be sterile, however, it must
Figure 1: The 2008 market share for reverse osmosis, ultrafiltration and microfiltration.
Feature
Filtration+Separation October 2008
RO, MF and UF will see continued growth at about 9 percent per year for the next few years. Figure 1 shows the market share of each process for 2008.
Cartridge filters Cartridge filtration is the technology most in use in the pharmaceutical and biotechnology industries, holding a total market size of over $2 billion for these industries.
Figure 2: The 2008 market share for each type of cartridge filter.
Cartridge filters are normally used for fluid polishing, with particle size to be separated smaller than about 50 microns. Surface filtration takes place in pleated filters while depth filtration is the mechanism in string wound, resin impregnated and molded cartridges. Depth filters have traditionally had a lower cost than surface filters. Cartridge filters are typically installed prior to the RO units. Cartridge filter types include membrane, nonwoven, carbon, string wound and metal. Membrane cartridge filters are ideal for the critical filtration needed in pharmaceutical and biotech manufacturing, hence having the largest market share at over $1 billion for 2008. Membrane filter materials include nylon, polypropylene, and PTFE.
Figure 3: The 2008 market share of macro filtration products.
Cartridge filtration is the widest used technology in the pharmaceutical and biotech industries, followed by reverse osmosis, ultrafiltration and microfiltration systems. The next largest market segment is for nonwoven cartridges, at $769 million. Nonwoven cartridges are used as a support layer for membranes, as well as on their own for less critical filtration applications. Carbon filters, used to achieve organic purity, hold a market share of $137 million. Metal and string wound segments are smaller, at $77 million and almost $48 million respectively. Figure 2 shows the market share by cartridge type for 2008.
Figure 4: The market share for sedimentation and centrifugation.
Reverse osmosis produces the finest level of filtration of all the membrane processes. Application of RO most often is to provide water which is almost free of solids, salts, organics and colloids to subsequent final polishing processes, such as ion exchange. The reverse osmosis equipment market for 2008 is close to $135 million, with the RO membrane market at almost $73 million.
The ultrafiltration process typically rejects organics over 1,000 molecular weight (MW) while passing ions and small organics. In the pharmaceutical industry, it is being used as a final filter in some pharmaceutical water purification systems. In 2008, the ultrafiltration equipment market is $241 million, and the membrane market is over $105 million.
Macro filtration Macro filtration, also known as liquid filtration, is characterised by particle removal between l and 100 micrometers in diameter. This segment includes leaf filters, bag filters and filter presses. A filter press is used for solid-liquid separation of pharmaceutical solutions. The solution to be filtered is made to pass through a thin membrane until the solid material is split from the liquid.
23
24
Feature
Filtration+Separation October 2008
The pharmaceutical industry is one of the smaller segments, but it is the highest growth segment. This is in part due to the critical role that disk separators play in the production of biotechnology products. The total world market in the pharmaceutical/ biotech industry for sedimentation & centrifugation products in 2008 is $325 million. Figure 4 shows the disk separators market for 2008 is the largest segment, at $115 million, followed by basket centrifuges at almost $108 million.
Ultrapure Water Systems New applications, new technology and new ways to operate are providing dynamic change to the ultrapure water industry. Power plants were early users of the technology. The semiconductor and pharmaceutical industries have been the biggest recent investors. Figure 5: 2008 market shares by filtration type.
These specialised equipments are also used to remove suspended particles from a solution and process water and wastewater treatment. Automatic pressure filters are designed for foods, pharmaceuticals and solvent-wetted products. Some features allow double-sided filtration for multiple cake washing and cake drying options. Automatic pressure filters can be seen in penicillin production to help increase recovery of the penicillinactive ingredient. The process involves making a fermentation, which contains the penicillin, and solid mycelia waste. The solids and the liquids are separated, and the liquid is extracted with solvents to remove the penicillin. The manufacturer can separate the solids and liquids in rotary drum vacuum filters, and dispose of the mycelia in the wastewater, but the vacuum filters can produce a fairly wet cake containing a significant amount of penicillin, which is lost. Replacing the vacuum filters with automatic pressure filters will give it a drier filter cake and clearer filtrate, as well as lower penicillin loss. Leaf filters employ a nest of filter discs spaced on a common shaft and fully enclosed within a pressure-resistant casing. Overall configuration may be vertical or horizontal. The filter nest is normally static for filtration, the suspension being passed through the nest under positive or negative (vacuum) pressure. Filtrate is withdrawn separately, with solids remaining on the filter disks as cake. Leaf design varies widely, from simple to complex mesh forms, with or without filter cloths fitted, and for use with or without precoat. A precoat is normally employed where fine filtering is required. Particular advantages of vertical leaf filters are good cake consistency with freedom from cracking or channeling
because the filter cake is not affected by pressure variations. Bag filters are widely used for the capture of solids and purification of liquids. The solid retaining capacity gives them advantages over cartridges. A wide variety of media can be selected for bag filter applications including rayon viscose, polypropylene, polyester and nylon. Bag filter vessels can be furnished in a variety of corrosion resistant alloys as well as carbon, steel and FRP.
The pharmaceutical purchases of ultrapure water systems (UPW) continue to grow at a steady rate of 6 percent to 7 percent per year and will exceed $267 million worldwide in 2008 and $345 million per year by 2012. Within this sector, biotech is growing much faster than the total pharmaceutical UPW market, with strong growth especially in India. A summary of the market shares by technology are illustrated in Figure 5. Cartridge filtration is the widest used technology in the pharmaceutical and biotech industries, followed by RO/UF/MF systems.
Cartridge filtration is the technology most in use in Disposable process equipment – a the pharmaceutical and growing trend biotechnology industries, holding Disposable process equipment is a fast a total market size of over $2 growing industry trend, as drug manufacturers billion for these industries. adopt single-use systems to reduce cleaning, Leaf, tubular and belt filtration holds a large market share of the macro filtration systems for the pharmaceutical and biotech industries. New equipment for these devices is near $108 million, with the media used at almost $44 million. The next largest segment in 2008 is bag filters, at $52 million for new equipment and $53 million for the bags. The 2008 market for macro filtration products is shown in Figure 3.
Sedimentation and centrifugation Separators used in the production and processing of, for example, human blood, vaccines, bacteria, algae and pigments, must meet stringent requirements. In certain situations, the process must run under sterile conditions, be fully automated and ensure economy and efficiency. Designs include a suspended bowl concept, completely segregated process and drive areas, and fully automatic operation to provide the sterile treatment of the product with highest possible efficiency.
sterilisation and their associated validation costs. According to single use system manufacturer Pall, disposables are in use over 90 percent of pharmaceutical and biotechnology companies’ manufacturing processes. Pall states that the systems reduce possibilities for FDA noncompliance, and also enable faster, more cost effective product changeovers. However, some drug makers who haven’t made the switch to disposables are concerned about the plastic materials leaching into product or contaminating solvent, and want to avoid getting locked into one source of the materials. To address these concerns, single use manufacturers have created The BioProcess Systems Alliance (BPSA), an industry organisation to promote single-use technology worldwide through education, industry guides, and support of standards development.
•
Contact: Karen Vacura Email: [email protected] McIlvaine Company