Sterile API is the foundation and source of pharmaceutical preparation enterprises, and its production quality assurance level is directly related to drug safety. The material liquid filtration in the production process and most of the solvents involved, especially the corrosive solvent filtration, put forward strict requirements for the chemical compatibility of the filter element. In combination with its laboratory process verification services, Dali provides constant production of filter products that meet the predetermined process standards and quality characteristics for pharmaceutical enterprises.
The preparation needs to "mix" the raw materials in some excipients or solvents to reach the required concentration, and can finally be provided to the drug delivery 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 keep the preparation uniform and stable, the active ingredients meet the medication requirements, and control the potential risks, the process needs to be equipped with accurate filtration solutions to ensure the compliance and safety of the preparation and meet the GMP requirements.
Biotechnology is developing rapidly in China. As an important part of modern medicine and biotechnology, biological products play a very important role in preventing and treating diseases and protecting and improving people's health. Biological products need multiple biological processes and purification and analysis techniques to obtain the target. Physical filtration has natural advantages and can creatively complete tasks. It is an indispensable process of biological products.
The public system needs to provide a stable and clean environment for production. Water, gas, compressed air and inert gas shall meet the cleanliness requirements of corresponding pharmaceutical processes, GMP and corresponding guidelines and regulations. The water required for production in the pharmaceutical industry is specially treated. In order to ensure the cleanness of the plant or no pollution in the fermentation process, the gas needs to be sterilized and filtered.
Integrity is a key issue in the production and use of filter elements. In many fluid (gas or liquid) filtration processes, it is required to maximize the integrity of the filter in the final stage of production and after actual use. Therefore, the sterilization filter of food and drugs must have strict integrity test, test documents and records.