Application of sterilizing filtration products in injection production process

2024-03-12 Eternalwater

Injections refer to raw materials or sterile preparations made with appropriate excipients for injection into the body. Injections are divided into large-volume injections (large infusion or LVP), small-volume injections (small injections or SVP) and powder injections according to their production technology characteristics and production processes. Among them: large-volume injection (LVP) is commonly known as large infusion, which refers to a volume of ≥ 50ml liquid sterilization preparation that is directly injected into the vein; small volume injection (SVP), commonly known as water injection, configures the drug into a solution (aqueous or non-aqueous), suspension or emulsion, and puts it into an ampoule or multi-dose container. The prepared sterile preparation has a general capacity of ≤20mL.

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Due to the particularity of the administration site of this type of preparation, its quality requirements and safety risks are very high. The sterility of the final product must be ensured, that is, the drug cannot contain bacteria and other microorganisms. This is also an important guarantee to ensure patient safety. Therefore, sterile filtration is particularly important in the entire process.

Filtration is widely used in different process stages of large and small volume injections. It mainly includes decarbonization filtration, particle removal and pre-filtration to reduce microbial load, gas sterilization filtration, redundant filtration and sterilization filtration of end products. etc. The main filtering sites are:
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1. Decarbonization filtration: remove activated carbon particles and colloidal impurities, extending the service life of downstream filters
2. Pre-filtration (particle removal): further remove activated carbon particles and colloidal impurities, extending the service life of downstream filters
3. Pre-filtration (reduce microbial load): Reduce microbial load and extend the service life of downstream sterilization filter elements
4. Redundant filtration: remove bacteria and microorganisms in the filtrate
5. Terminal sterilization filtration: remove bacteria and microorganisms in the terminal filtrate
6. Respirator: balance tank pressure and prevent pollution

Common large and small volume injection production processes

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