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 example
Large 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
Company Name: Shenzhen Infinipure Technology Co., Ltd
Factory Add: #forth Building, DingHao Industrial Area, QiuChang Town, HuiYang District, HuiZhou City, Guangdong Provice , China.