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Sterile API

Aseptic API is the basis and source of pharmaceutical preparation enterprises, and the quality assurance level of its production is directly related to drug safety. The chemical compatibility of the filter element is strictly required by the material and liquid filtration in the production process and most of the solvents involved, especially the corrosive solvent filtration. Dali combined with its laboratory process verification services to provide pharmaceutical companies with filtration products that meet the predetermined process standards and quality characteristics. China is a major producer of API. In each link of the pharmaceutical industry chain, China plays a role in the processing and manufacturing of basic pharmaceutical raw materials, including fermentation, chemical synthesis, and animal and plant extraction. The filtration process provides a guarantee that the process operating within the predetermined parameters can continuously and effectively produce drugs that meet the predetermined specifications and quality standards.Take semisubstance (semi-chemically synthesized antibiotics) as an exampleFermentation is also one of the important methods for the production of API. In particular, antibiotics API, such as penicillin and cephalosporin, are usually obtained by semi-synthesis combining fermentation with chemical synthesis.Main filter points and applications:1. Filter/material of main solvent: acetone, ethyl acetate, ethanol, triethylamine. Recommended for final filter: stainless steel shell +PTFE 0.22 m filter element. Prefilter/stainless steel housing +PTFE or PP material with different precision as required.2, cefoic acid and cefosalt filtration/main materials: cefoic acid, cefosalt, final filter recommended: according to the needs of pre-filter/stainless steel shell +PTFE or PP material with different precision3. Inorganic salt filter/Main materials: sodium acetate, sodium iso-octanoate, final filter recommended: stainless steel shell +PTFE0.22 m or PES0.22 m filter core.4, activated carbon decolorization/main materials: inorganic salt, cefoic acid. Filter remove activated carbon, filter recommended: titanium rod, deep filter reactor.5. Respirator filter (respirator) : Recommended configuration: stainless steel housing +PTFE0.22 m filter element6. Gas filtration: nitrogen, compressed air, stainless steel shell +PTFE0.22 m filter element is recommended; Choose to fold 1-3 microns with or without stainless steel case +PP depending on the specific situation. Note: For detailed technical solutions, please contact your sales engineer. Process examples:

Preparations

The preparation needs to "mix" raw materials in some excipients or solvent to achieve the required concentration, and can finally be provided to the drug object for use. Different forms of preparation solve the problem of drug usage and dosage, but also put forward higher requirements for safety. In order to maintain the uniformity and stability of the preparation, meet the requirements of active ingredients, and control potential risks, the process needs to be equipped with accurate filtration solutions to ensure the compliance and safety of the preparation and meet the requirements of GMP. China is a major manufacturer and user of pharmaceutical preparations. The preparation USES modern medical technology to disperse the drugs in the system with special structure, so as to change the pharmacokinetic characteristics and tissue distribution of the drugs in vivo, so as to improve the efficacy of the drugs. This requires uniform pore size of the filter element, strong retention ability, no particle leakage; No medium migration, does not affect the pH of the solution; The absorbency is small, the filtration speed is fast, does not affect the main drug content. Take filtration of LVP for exampleLarge Volume Parenteral LVP, i.e. Large Volume of Parenteral Parenteral fluid (LVP), the filtration system needs to provide a stable and high flow rate to ensure accurate and stable filling. Remove low biological load before final sterilization.1. If the raw materials contain asbestos fibers, remove them from the final product. A 0.22 m sterilizing filter should be used.2. If it contains ingredients that cannot be sterilized by heat, a 0.22 m sterilizing filter should be used.3. In the case of final thermal sterilization, the purpose of filtration is only to reduce the microbial load. A 0.45 m filter element can be selected.4. For WFI (Water For Injection) and respiration mouth filtration of sterile product storage tank, a hydrophobic PTFE 0.22 m filter element can be selected. Note: For detailed technical solutions, please contact your sales engineer. An example of production process for sterilized large volume injection

Biological Products

Biotechnology is developing rapidly in China. Biological products, as an important part of modern medicine and biotechnology, play a very important role in the prevention and treatment of diseases, protection and improvement of people's health. Biological products need to go through multiple biological processes, purification analysis technology, to get the target. Physical filtering, with its natural advantages, can creatively complete the task, is an indispensable process for biological products. Biological products, with microorganisms, parasites, animal toxins, biological tissue as the starting material, most of the source, production process and other uncontrollable factors are too much. The types and quantities of impurities expressed by biological substances cannot be accurately predicted. The number and quantity of substances remaining in the original solution are usually controlled only by the items specified in the quality standards, while other impurities are difficult to be fully controlled. Comprehensive control is the basis of sound production. Take calf serum for exampleAmong the main components of culture medium, animal serum plays an irreplaceable role in the growth and reproduction of cells, among which bovine serum is the most widely used and an important raw material in medical biotechnology products. Ensuring the quality of bovine serum is an important link to improve the quality of biological products, and filter element is of vital importance. Other points of attention in filtration process:1. Application of crude serum: raw calf serum thawed, 8-9 layers of gauze, removing some sticky substances;2, filtering, protect the filter: additive step 0.45 1  m prefiltering, step or two prefiltering 2-3  m + 0.45 1  m.3, finally filtering: 0.22  m and 0.1  m filter in addition to bacteria, mycoplasma, ensure that no bacteria, mycoplasma in finished products. The filter element is subject to appropriate challenge tests and provides integrity test data associated with the results.4. Integrity detection of 0.1 m membrane filter element was performed before and after serum filtration. Note: For detailed technical solutions, please contact your sales engineer. Process drawing (none)

Public System

The public system needs to provide a stable and clean environment for production. For water, gas, compressed air, inert gas, etc., it should meet the cleanliness requirements of the corresponding pharmaceutical process, GMP and the corresponding guidelines and regulations. In the pharmaceutical industry, the water needed for production is specially treated. In order to ensure the plant is clean or the fermentation process is pollution-free, the gas needs to be sterilized and filtered. The stable public system provides a strong support for continuous production. Water, gas and air environmental systems in production are subject to special treatment to meet their own characteristics and the requirements of GMP and corresponding guidelines and regulations.Water for production: purified water, water for injection, water for sterilization, etc. Among them, a 0.2 m hydrophobic ventilation filter is installed at the breathing mouth of the distilled water storage tank. Fill with nitrogen and add a 0.2 m hydrophobic filter for filtration.The air conditioning system shall control the microorganisms within the prescribed standards by means of sterilization, sterilization and disinfection.Gas filtration: biological fermentation process, enzyme catalysis process and cell tissue culture process of biopharmaceutical, which requires sterile and impurity free purified air, or purified nitrogen, or purified carbon oxide and other inert gas or nutrient gas. The required compressed air should be sterilized and filtered. Try to choose hydrophobic filter materials, such as PP, PTFE, PVDF, GF, etc. For example, fermenter air filtration:Prefilter PP film 1-3 m nominal accuracy, about 10 m absolute accuracy; 10 m absolute precision steam particulate removal filter made of stainless steel sintered material; 0.22 mPTFE membrane sterilizing filter.All gas sterilizing filter elements are required to undergo 100% integrity test before leaving the factory. During use, the integrity test should be carried out on the filter element to ensure that the test value of the filter element is within the standard value range and that the filter element is in good condition to achieve the purpose of sterilizing.Note: For detailed technical solutions, please contact your sales engineer.