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.
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.
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.
Integrity is a key issue in the production and use of filter elements. In many fluid (gas or liquid) filtration processes maximum assurance is required of the integrity of the filter during the final stage of production and after actual use. Therefore, strict integrity tests, test documents and records must be in place for sterilization filters for food and drugs. DLE detection instrument can be used for the filter element bubble point, diffusion flow, water intrusion inspection, and can realize the joint inspection of the diffusion flow and bubble point, inspection data is displayed in the form of chart, direct feedback of the quality and technical data of the filter element, for the convenience of customer data analysis.
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.