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The fermentation process, enzyme catalysis process and cell tissue culture process of biopharmaceuticals require sterile and impurity-free purified air, or purified nitrogen, or purified carbon oxides and other inert gases or nutrient gases. The required compressed air needs to be sterilized and filtered. All gas sterilization filter elements have passed the 100% integrity test before leaving the factory. In the process of use, the integrity test of the filter element should also be carried out to ensure that the test value of the filter element is within the standard value range, to ensure that the filter element is in a good state and to achieve sterilization purpose.
Sterile API
Sterile APIs are the foundation of pharmaceutical preparation companies, and the quality assurance level of their production is directly related to drug safety. The filtration of material and liquid in the production process and most of the solvents involved, especially the filtration of corrosive solvents, put forward strict requirements on the chemical combability of the filter element.
Jielv filter provides pharmaceutical companies with constant production of filtration products that meet the predetermined standards and quality characteristics of the process.
Pharmaceutical preparations:
Pharmaceutical preparations need to mix raw materials with certain excipients or melt medical to achieve the required concentration, and can finally be used by the administration object. Different forms of preparations solve the problem of drug usage and dosage, but also put forward higher requirements for safety. In order to keep the preparation uniform and stable, the active ingredients meet the drug requirements, and at the same time control potential risks, the process needs to be equipped with accurate filtration solutions to ensure that the preparation is compliant and safe and meets GMP requirements.
Biological Product:
With the rapid development of our biotechnology, biological products as an important part of modern medicine and biotechnology. It plays a very important role in preventing and treating diseases and protecting and enhancing people’s health. Biological products need to go through multiple biological processes, purification and analysis techniques to obtain the target. Filtration through the physical method of the filter element is an indispensable process for biological products.
Public system:
The stable public system provides strong support for the continuous production of enterprises. Water, gas and air environmental systems in production require special treatment in order to meet their own characteristics and the requirements of GMP regulations. Such as water required in production process: purified water, water for injections, sterile water for injection and so on.
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