Preparations
The preparations are made according to certain dosage form requirements in order to meet the needs of treatment or prevention, and can be finally provided to the drug subject for use.
Common ones include large volume parenteral, small volume parenteral, lyophilized powder injections, eye drops and so on.
Injection refers to the sterile preparation made of raw drugs and suitable auxiliary materials for injection into the body. According to the characteristics of production technology and production process, injections are divided into large volume injection (LVP) and small volume injection (SVP). Large volume injections are generally defined as infusion products with a volume greater than 50 mL, while small volume injections usually refer to preparations below 50 mL.
Small volume injections are commonly filled into ampoules or multi-dose containers, with a general volume of ≤20 mL.
Due to the particularity of the drug delivery route, the drug preparation must meet strict quality requirements and safety risks are very high.
It is necessary to ensure the sterility of the final product, that is, the drug must not contain microorganisms, which is also an important guarantee to ensure the safety of patients. Therefore, sterile filtration is particularly important in the whole process.
Filtration has a very wide range of applications in different process stages of large and small volume injections, mainly including decolorization filtration, prefiltration, terminal sterilization filtration, redundancy filtration, gas sterilization filtration and terminal filtration.
The main filtration steps are:
- Decolorization filtration: remove activated carbon particles and coloring impurities, extend the service life of downstream filter elements
- Prefiltration (remove particles): further removal of activated carbon particles and colloidal impurities, extend the service life of downstream filter elements
- Prefiltration (reduce biological load): reduce microbial load and extend the service life of downstream sterilization filter cartridges
- Redundancy filtration: remove bacteria and microorganisms from the filtrate
- Terminal sterilization filtration: remove bacteria and microorganisms from terminal filtrate
- Respirator: balance tank pressure and prevent contamination
Recommended Filtration Products for API Biotechnology
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Our validation system includes comprehensive management procedures and technical support, ensuring filtration processes are efficient, compliant, and reliable. This helps customers improve filtration performance and maintain stable production processes.
