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In the food and beverage industry, the filtration process is crucial for ensuring product quality and safety. The importance of food and beverage filtration is reflected in the following aspects: Improving Product Quality: Filtration can remove impurities and particulates from food and beverages, thereby enhancing the purity and taste of the products, ensuring that consumers receive high-quality products. Extending Shelf Life: By removing microorganisms and spores through filtration, the risk of product spoilage and deterioration can be reduced, extending the shelf life of food and beverages. Meeting Regulatory Requirements: Many countries and regions have strict food safety regulations that require food and beverages to meet certain hygiene standards during production. Filtration is an important step in meeting these regulatory requirements. Protecting Production Equipment: Filtration can prevent large particulates from entering production equipment, reducing wear and breakdowns, and extending the service life of the equipment. Increasing Production Efficiency: Filtration can reduce downtime during production because the need for cleaning and maintenance is reduced, thereby increasing overall production efficiency. Ensuring Food Safety: Filtration is one of the key components of food safety management and can effectively remove bacteria, viruses, and other harmful substances that may cause food poisoning. Improving Product Appearance: Filtration can remove suspended solids and sediments that affect the appearance of products, making them look clearer and more visually appealing. Reducing Waste: Effective filtration can reduce the number of non-conforming products, minimizing the waste of raw materials and energy. Adapting to Market Demand: As consumer demand for healthy and natural products increases, filtration technology can help manufacturers provide purer products with fewer additives, meeting market demand. Supporting Sustainable Development: By reducing waste and improving resource utilization efficiency, filtration contributes to the sustainable development of the food and beverage industry.

Applications

Filtration is important within the biopharmaceutical development process. Both the final sterilization and pre-filtration of the feed liquid and the filtration of the intermediate are very important. Selecting the right filter can purify the medium and can remove impurities, bacteria or other contaminants from the system. In addition, the stability of the product, the filtration efficiency, the sterilization cycle, the difference in the filtration medium and the chemical resistance of the filtration need to be considered when selecting the filter.

SANITEK has 10,000 grade producting department to ensure products safety. Our filters are constructed from FDA-approved materials with CFR21(Title 21 of the Code of Federal Regulations) biosafety numbers, and these polymer materials meet USP Class VI-121°C medical grade plastic requirements.Our aseptic grade filters are reliably designed and manufactured and are fully verified to contain at least 107 pseudomonas bacteria per square centimeter of filtered area, complying with the US Food and Drug Administration (PDA) aseptic filtration regulations. We produce a full range of filter products from pre-filter to terminal filter, from small mini cartridge filter to capsule filter to standard cartridge filter, and we also provide sanitary filter housing matching with them. The filter housings also include single core, different heights and multi-core mass production products to suit your different applications.

Filter elements include five series:

Biopharmaceutical technology occurred in the late 20th century, modern biopharmaceutical technology originated from the traditional pharmaceutical technology, but also made up for the lack of traditional pharmaceutical technology. Since the main components of biopharmaceutical products are sugars, proteins and fats, it has the characteristics of high safety, low toxicity and high nutritional value compared with other drugs,which is one of the reasons why biopharmaceutical technology has received extensive attention and rapid development. The biopharmaceutical industry is mainly subdivided into sterile APIs, biological products, etc..

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Pharma plus-circle minus-circle

Pharma refers to the drug made in accordance with the requirements of a certain dosage form to meet the needs of treatment or prevention, and can be finally provided to the drug object. Common Pharma include large infusions(LVPs), small infusions(SVPs), eye drops, traditional Chinese medicine injections, etc..

The conventional pharma manufacturing process involves:

The conventional pharma manufacturing process involves

APIs plus-circle minus-circle

Active pharmaceutical ingredients(APIs)are the premise of the production of pharmaceutical preparations, and play the role of processing and manufacturing of basic pharmaceutical industry raw materials in all links of the pharmaceutical industry chain. The production process of API includes chemical synthesis, fermentation, animal and plant extraction, etc. According to the sources obtained, APIs are generally divided into chemical synthesis APIs, animal and plant extraction APIs, and production of fermentation and cell culture APIs. Basing on the different microbial level of the product and the target dosage form, APIs are also divided into non-sterile APIs and sterile APIs. The same as sterile preparations, sterile APIs are also divided into final sterilized sterile APIs and non-final sterilized sterile APIs, but because most APIs are sensitive to high temperature and heat, high humidity and pressure, radiation, few sterile APIs are used for final sterilization. At present, non-final sterilization of sterile APIs is usually the last step of the product refining or salting combined with the sterilization process, using pre-filtration plus two stages of 0.22um sterilization filtration to achieve the final product sterility. The sterilized filtrated liquid is usually crystallized, freeze-dried or spray-dried to produce the final sterile API product.

How is the preparation process of API and what are the filtration positions in the process?

Taking antibiotics for example,The following positions are involved:

How is the preparation process of API and what are the filtration positions in the process

Biological Product plus-circle minus-circle

Biological Product refers to drugs made from microorganisms, cells, animal or human tissues and body fluids using traditional technology or modern biotechnology for the prevention, treatment and diagnosis of human diseases. Biological products include vaccines, blood products, monoclonal antibodies, recombinant protein drugs, gene & cell therapies, diagnostic reagents, etc. Part of the product is obtained by tissue cell culture or microbial fermentation, and the other part is by extracting the target from the blood. The preparation process of biological products is complex and the product purity is high, so filtration plays an important role in the product quality control process. Taking the vaccine preparation process for example: Vaccine is a non-pathogenic immunogen, which is essentially an antigen, which guides the body to produce specific dynamic immunity after inoculation to the human body to protect the human body from the invasion of corresponding pathogens or prevent tumors. So far, there have been three generations of vaccines: inactivated vaccines & live attenuated vaccines; Subunit vaccine; Genetic vaccine.

Public system water/gas plus-circle minus-circle

The public system of biopharmaceutical production includes water for production, water for injection, compressed air and fermentation gas, etc. Maintaining the stability of the public system is the basic requirement of production. Public system water: In the pharmaceutical industry, water is the most widely used and the most basic process raw materials, used as components of drugs, solvents, diluents and equipment pipeline cleaning. GMP stipulates that pharmaceutical water should be at least potable water. In actual production, pharmaceutical water can be divided into three categories according to its use: Drinking Water: Usually the tap water supplied by the water company or deep well water, also known as raw water. The quality of drinking water must meet local national standards, and generally drinking water cannot be used directly for preparation or testing of preparations. Purified Water (Purified Water) : pharmaceutical water obtained from raw water by distillation, ion exchange, reverse osmosis or other appropriate methods, and does not contain any additives. Purified water prepared by non-heat treatment such as ion exchange, reverse osmosis and ultrafiltration is also known as deionized water. Water for Injection: It is purified water as raw water, distilled by a specially designed distiller, condensed and cooled, and then prepared by membrane filtration. Among them, Sterile Water for Injection is water that is prepared according to the sterile water production process.

The main filtration processes for water used in public systems are involved:

Public system gas:

In pharmaceutical manufacturers, public gases include compressed air, nitrogen and carbon dioxide etc., of which compressed air is the most widely used. Compressed air is directly in contact with machine parts during compression and transportation, so the compressed air output by the air compressor contains impurities such as solid particles, water, oil, microbial bacteria and odor. The purpose of filtration is to remove these impurities and ensure the safety of downstream using.

The main filtration processes for compressed air used in public systems are involved:

Prefiltration/ Clarification

Pre-filtration usually refers to the first step in the filtration process, aiming to remove large impurities or particles in the feed liquid, requiring the filter to carry a large amount of pollution and a high flow rate at low pressure difference. At the same time, the installation of the pre-filter can also protect the downstream filter, improve the service life of the downstream filter, and reduce the total cost. It varies according to the media of the pre-filter, the chemical properties of the feed liquid, the throughput and the sterilization conditions, etc..

Each pre-filtration application has specific requirements, with a single filter for single layer media, a single filter for multiple layers of media, or multiple filters in series.If the size of the particulate matter in the filtered media is clear, the single-layer filter is sufficient; If the composition of the impurities in the filtered media is more complex, it may be necessary to use multi-layer pleated filters or multiple single-layer filters in series, typically these filters called depth filter made from polypropylene or fiberglass.

Prefiltration clarification01

SANIpure® PP filters

SANIpure® PP series adopts high quality polypropylene media, with nominal precision single layer , multi-layer pleated and absolute precision single layer three media to choose from, to meet the needs of different pre-filtration applications. The structure of the full polypropylene provides good chemical compatibility and is suitable for the filtration of most feed liquids.SANIpure® PP series have excellent performance, combined with high dirt holding capacity, high flow rate at low pressure drop and long service life, resulting these cost-efficient filters.

Available Formats

SANIpure® GF filters

The SANIpure® GFS prefilter are composed of fine glass microfiber with high dirt holding. This combination provides the filter with an inherently absorptive characteristic that enhances filter retention capacity. They are highly recommended for the filtration of liquids containing gels, lipids and proteins.

Available Formats

Metal Filtration/ Clarification

Stainless steel filter element has very good filtration performance, the main filter material adopts multi-layer stainless steel sintered mesh, folded sintered felt, folded wire mesh, sintered stainless steel powder and titanium powder etc., the filtration accuracy is 0.5-200um, and its dimensions can be processed according to user requirements.

Stainless steel filter element is resistant to high or very low temperature, optional porosity of 28%-50% , optional accuracy of 0.2um – 100um; Good corrosion resistance,is suitable for a variety of acid, alkali and other corrosive media and sulfur-containing steam. And the stainless steel filter element has high strength and good toughness, which is suitable for harsh high-pressure and high-temperature conditions. After repeated cleaning and regeneration, the filtration performance is restored to 90%.

SANITEK offers four types of stainless steel filters: CSSM® with muti-layer 316 or 304 stainless steel mesh, PSF® with stainless steel fiber sintered felt, PSM® with woven stainless steel mesh ,and PSM® with Titanium sintered. These filters are usually used for the decarbonization of pharmaceutical liquids, the decontamination of disinfecting water, and steam filtration in the biopharmaceutical industry.

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Available Formats

Sterile Liquid Filtration

Sterilization grade filtration is a “cold” sterilization method that differs from traditional heat sterilization in that it aims to remove microorganisms through the filtration membrane rather than kill them. For some biological products or reagents that cannot be used for heat treatment, filtration sterilization is the only and most important way to remove bacteria.

The membrane medias of the sterilizing filters usually have PES, PVDF,Nylon6,6, and CA, and these medias are usually stable in nature and do not react with the feed liquid. However, for some special solutions, such as protein solutions, there may be a problem of protein adsorption by the membrane, so PVDF with low protein adsorption can be tselected. Therefore, the appropriate degerming filter should be selected according to the different degerming application.

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SANIpore® PES filters

SANIpore® PES series is an efficient bactericidal removal series, equipped with bioburden reduction, sterilizing, double-layer sterilizing membrane medias.These folding filter has the characteristics of ultra-low protein adsorption, dissolution/precipitation level, uniform pore size distribution, excellent bacterial retention ability, and excellent initial flux. This makes it the ideal filter to ensures bio-burden or sterilizing and small particle removal in a wide range of biological liquids, and intermediate bulk pharmaceutical fluids. 0.1 μm rated filter cartridges are especially developed for validated sterile filtration and reliable mycoplasma removal from any media.

Available Formats

SANIpore® Nylon6,6 filters

Nylon6,6 membrane filter is a widely used filter medium made of nylon6,6 media, mainly used to separate and filter particles and impurities from the liquid, remove microorganisms from the filter liquid. Nylon6,6 microfiltration membrane has the characteristics of natural hydrophilicity, chemical resistance (dilute acid, dilute alkali, alcohol, oil, hydrocarbons, and other organic inorganic compounds), high strength, high temperature resistance (up to 90℃), high flow rate, wide aperture range, etc., suitable for sterile filtering and intercepting impurities of various sizes. Nylon6,6 membranes filters are the ideally used in a variety of pharma, biopharma and chemical industrial applications, where they can be sterilized by autoclaving, gamma radiation, and other methods, making them suitable for sterile filtration applications.

Available Formats

SANIpore® PTFE filters

PTFE membranes are naturally hydrophobic, making them the best choice for gas filtration. PTFE microporous membrane has the characteristics of smooth surface, chemical resistance, air permeability, water permeability, flame retardant, high temperature resistance, strong acid and alkali resistance, non-toxic, etc., can be widely used in a variety of gas filtration and strong organic solvent filtration. And the running resistance is low, the filtering speed is fast; Long service life, reusable, thus reducing operating costs.

PTFE membranes can also be modified by surface, from hydrophobic to hydrophilic, suitable for the filtration of some hydrophilic highly corrosive liquids, such as disinfectants, strong oxidizing solvents, strong acids or strong alkalis.

Available Formats

SANIpore® PVDF filters

PVDF membrane has a variety of properties, so that it is widely used in fine chemistry, biomedicine, food and beverage and other fields. PVDF medium mainly has the following characteristics: good chemical corrosion resistance and temperature resistance, can withstand most chemicals and poor working conditions; Ultra-low protein adsorption, can be used to filter precious protein solutions; High biocompatibility, no cytotoxicity, can be used in harsh filtration processes; High tensile strength, durable, provide long service life.

SANITEK offers hydrophilic, high-performance PVDF pleated element filters that are particularly suitable for debacterialization filtration in the biopharmaceutical industry.

Available Formats

Vent/Gas Filtration

As one of the main components of the public system in industrial production, the quality of gases determines the cleanliness and production security of the entire factory, so gases filtration plays a very important role in industrial production especially in biomedical industry.

Taking respirator for example:
For liquid storage tanks or reaction tanks, a respirator is necessary to maintain the pressure balance in the tank. When the liquid in the tank is filled, the air in the tank must be discharged; In contrast, when the tank liquid is emptied, the lost liquid volume must be compensated by air or gas. Therefore, the air or gas entering the tank must be aseptic to ensure that the feed liquid is not contaminated. Usually, hydrophobic membranes are used for gas filtration, such as PTFE, which can also reduce the risk caused by bacteria in the wet element filter while efficiently removing bacteria.

vent filter gas

Available Formats

Endotoxin Removal Filtration

Endotoxin is mainly derived from the outer cell wall of Gram-negative bacteria. Because endotoxin can firmly bind to the cell wall, it is usually released only after the death of the bacteria and the cell wall is dissolved. Therefore, it is widely found in nature, including tap water, air, and even food. Endotoxin in any way into the human body will cause harm to the human body, not only through the digestive tract, so the market of injections, oral medicine and chemicals, medical devices, etc., must go through a strict endotoxin free test.

The surface of the specially modified positively charged NY6,6 membrane can absorb the negatively charged endotoxins, viruses and cells in the fluid through static electricity. SANIendo® series filter is an excellent choice for pharmaceutical and bio-processing applications to remove endotoxin.

Available Formats

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