Columbia Pharmaceutical Filtration Market Research Report, 2030

The early use of filtration in Colombia's vaccine production can be attributed to the activities of the Instituto Nacional de Salud (INS) and public biomedical programs in Bogota between the mid-to-late 20th century. To ensure particulate removal and microbial reduction during serum processing, simple depth and membrane filters were utilized as Colombia increased its domestic vaccine production, particularly for yellow fever and rabies. As sterile filtration eventually became a regulatory requirement for injectable vaccines, state-run labs and commercial partners started using validated 0.2-micron membrane filters into their production. Filtration is used extensively in public pharmaceutical initiatives that are funded by the government to produce antibiotics, analgesics, and treatments for chronic illnesses that are distributed through POS (Plan Obligatorio de Salud) channels. When serving Colombia's rural and marginalized communities, these programs rely heavily on prefiltration and sterile filtration to comply with safety standards. Filters are crucial to the operation of compounding pharmacies, which produce drugs for public hospitals in accordance with Ministry of Health agreements. Due to variable power supply, high humidity, and limited access to cleanrooms, areas like the Amazon basin, Chocó, and Guajira experience severe filtration issues. Because of this, keeping sterile processing environments is more difficult, making strong prefiltration and mobile filtration systems essential in these areas. To concentrate proteins and remove endotoxins from biologics and biosimilars, which are increasingly made by Colombian companies like BIOMM and VaxThera, ultrafiltration and tangential flow filtration (TFF) are used. These demand careful management and routine integrity checks, which are typically centered in cities like Cali and Medellín. There is still a significant gap in the industry's workforce's technical training. Many facilities do not have qualified personnel who are trained in filter integrity testing, system validation, and sterile filter replacement procedures. It is essential to improve education through SENA and collaborations with foreign filtration businesses in order to raise filtration reliability and GMP adherence throughout the Colombian pharmaceutical industry. According to the research report, "Colombia Pharmaceutical Filtration Market Research Report, 2030," published by Actual Market Research, the Colombia Pharmaceutical Filtration market is expected to reach a market size of more than USD 140 Million by 2030. Increased local pharmaceutical production, rising investment in biologics, and improved enforcement of sterility standards in both public and private drug manufacturing are driving growth. The majority of the demand comes from local generic drug manufacturers, who control the pharmaceutical market in the nation and are gradually incorporating cutting-edge filtration technology into their production chains. Government subsidies, primarily via the Ministry of Health and Social Protection, have helped stimulate demand by encouraging technology improvements for the manufacture of vital medicines and supporting public manufacturing programs. Local manufacturers who are members of Plan Nacional de Desarrollo (PND) or who have partnerships with regional EPS networks are eligible for co-funding for GMP-compliant filtration systems, particularly for injectable and ophthalmic medications. Businesses like Tecnoquímicas and Laboratorios La Santé have pioneered recent filtration advancements by implementing automated capsule filtration units and single-use systems in sterile injectable lines. These advancements lessen the likelihood of contamination and allow for quicker batch changes, which is essential for generic medicines that are subject to price controls. Notable vendors include Merck Millipore, which sells PES membrane filters for sterilization; Sartorius, which is renowned for its ultrafiltration and TFF devices; and the Colombian company Filtros y Mallas Ltda, which specializes in depth and capsule filters for small to mid-sized pharmaceutical labs. These suppliers are essential partners in achieving national standards since they offer support for both validation and post-installation maintenance. But adherence to the standards set by the National Institute for Food and Drug Surveillance (INVIMA) is still a concern. For sterile product licensing, several smaller labs have trouble meeting the requirements for filtration validation, filter integrity testing, and cleanroom classification.

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Product segmentation in filtration in Colombia's changing pharmaceutical market is becoming more dependent on the infrastructure and application-specific requirements. Particularly for ophthalmic treatments and parenterals, membrane filters are the cornerstone of sterile medicine production. These are mostly PVDF-based and polyethersulfone (PES) membranes that are employed for microbial retention. The impetus behind their adoption is INVIMA's campaign for tighter adherence to sterility and batch integrity. Depth media and prefilters are still frequently utilized as upstream clarifiers in the processing of raw materials, which aids in lowering particulate load and bioburden before sterile filtration. They are particularly important in establishments that work with herbal extracts or biosynthetic active pharmaceutical ingredients. In cities like Bogotá and Medellín, where newer biologics facilities and CDMOs have incorporated disposable filter assemblies for flexibility, less cleaning validation, and lower cross-contamination, single-use systems are becoming more popular. In line with international GMP standards, these systems are now being utilized more and more in monoclonal antibody development and vaccine fill-finish lines. Cartridges and capsules are still essential for high-throughput fluid streams, particularly in oral solid dosage preparation environments. Their modularity allows for quick replacement cycles, which makes them ideal for facilities that produce a variety of products. Although frequently disregarded, filter holders are essential for maintaining operational pressure integrity and compliance during validation steps, especially in laboratories utilizing outdated systems. In cleanroom settings where airflow control and pressure regulation are essential for preventing contamination, filtration equipment like pressure gauges, vent filters, and tubing assemblies are necessary. Innovations now being tested in pilot programs by academic collaborations and Colombian R&D hubs fall under the others category. These include antimicrobial-coated filter assemblies, hybrid membranes, and nanofiber mats. In particular, microfiltration is the most widely used technique in the last stage of drug preparation to guarantee the elimination of bacteria and particles larger than 0.1 micron. In the production of antibiotics, injectables, and ophthalmic solutions, this technique is widely employed. Due to its minimal protein binding and compatibility with a variety of solvents, Colombian facilities prefer microfilters based on PES. In contrast, the concentration and purification of monoclonal antibodies and protein-based pharmaceuticals are major applications of ultrafiltration. It is a crucial component of the biotechnology manufacturing facilities in Bogotá's Zona Franca and Medellín's industrial areas, where a number of local businesses are working on biosimilars. This approach facilitates accurate separation by molecular weight cut-off (MWCO), which is essential for eliminating pyrogens, viruses, and aggregates. In upstream bioprocessing, particularly in cell culture clarification and fermentation broth filtration, tangential flow filtration (TFF), also known as cross-flow filtration, is becoming more and more popular. Colombian contract development and manufacturing organizations (CDMOs) are utilizing TFF for batch consistency and process scalability in the development of vaccines and blood plasma-derived treatments. With particular uses in hormone synthesis and API recovery, nanofiltration is still an emerging technology. Because of its capacity to eliminate organic molecules and hold on to small ones, it's perfect for treating pharmaceutical effluents in complicated drug formulations and controlling the environment. The others category includes cutting-edge methods like electrospun membranes, backflushable filter systems, and hybrid ultrafiltration-nanofiltration modules that are being tested in collaboration with universities such as Universidad Nacional de Colombia. These advancements seek to lessen fouling, increase throughput, and extend filter life, particularly in GMP-compliant establishments in rural areas. Particularly for vaccinations, biologics, parenteral medications, and ophthalmic solutions that are given intravenously or intramuscularly, sterile filtering is essential. Usually having pore diameters of 0.2 microns or less, these filters provide the thorough elimination of bacteria and microorganisms without affecting the product's makeup. Sterile filtration is frequently used in Colombian GMP-certified facilities during aseptic filling and before the finished product is packaged. This strategy meets INVIMA's sterility assurance criteria and is consistent with global WHO prequalification criteria, particularly for vaccines that are sent to other Latin American countries. On the other hand, the manufacture of oral solids, syrups, and topical preparations, where microbial presence is permitted within pharmacopoeial boundaries, mostly uses non-sterile filtration. These filters are designed to remove particles and improve clarity rather than kill germs. Environmental air or water filtration in non-classified cleanroom locations, raw material purification, and excipient clarification are among the uses. Generics companies and smaller pharmaceutical businesses that concentrate on regional and local markets frequently employ non-sterile methods. The difference is clear in the validation and design of the filter. Non-sterile alternatives are often cheaper and easier, with fewer validation steps, while sterile filters need to be produced in ISO 7 or cleaner environments and need integrity testing (such bubble point or diffusion tests). Cellulose-based or nylon filters are sufficient for non-sterile uses, but sterile filters typically employ cutting-edge materials like PTFE, PVDF, or PES. Technicians are learning the significance of this separation through training programs, particularly in publicly funded pharmaceutical centers in cities like Cali and Barranquilla.

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Nikita Jabrela

Business Development Manager

Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Pharmaceutical Filtration Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation By Product • Membrane Filters • Prefilters & Depth Media • Single-use Systems • Cartridges & Capsules • Filter Holders • Filtration Accessories • Others

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By Technique • Microfiltration • Ultrafiltration • Cross Flow Filtration • Nanofiltration • Others By Filteration Type • Sterile • Non-sterile The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.