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Preparations

The preparations are made according to certain dosage from 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.
Injections refer to the sterile preparations 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 injections(large volume parenteral or LVP) and small volume injections(small volume parenteral or SVP) and lyophilized power injections. Among them, large volume injections(LVP), commonly known as large volume parenteral, refer to liquid sterile preparations with a volume ≥50ml and directly injected into the vein; Small volume injections(SVP), commonly knows as water injections, are sterile preparations made by preparing drugs into solutions(water-based or non-water-based), suspensions or emulsions, and filling them into ampoules or multi-dose containers, with a general volume ≤20mL.
Due to the particularity of the drug delivery site of this kind of preparation, its quality requirements and safety risks are very high. It is necessary to ensure the sterility of the final product, that is, the drug can not contain bacteria and other 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 decarbonization filtration, prefiltration for particle removal and reduction of microbial load, sterilization filtration of gas, redundancy filtration and sterilization filtration of terminal products, etc. Its main filtration sites are:

1. Decarbonization filtration: remove activated carbon particles and colloidal impurities, extend the service life of downstream filter element
2. Prefiltration(remove particles): further removal of activated carbon particles and colloidal impurities, extend the service life of downstream filter element
3. Prefiltration(reduce microbial load): reduce microbial load and extend the service life of downstream sterilization filter cartridge
4. Redundancy filtration: remove bacteria and microorganisms from the filtrate
5. Terminal sterilization filtration: remove bacteria and microorganisms from terminal filtrate
6. Respirator: balance tank pressure, prevent pollution

 

The flow diagram of LVP/SVP isroughy as follows:

 

Preparations

 

After understanding the process needs of customers, Membrane Solutions provides customers with stable and reliable products for a long time, and can provide perfect filter cartridge process validation. Membrane Solutions has a complete process Validation Service Center with complete management procedures, standard test procedures and standard operating specification, which is divided into core validation service center/process validation service center. It provides a variety of testing and validation services for pharmaceutical companies and filter manufacturers. Its validation support services simplify the validation process for customers in terms of filter regulations, making the entire injection preparation process more cost-effective and reliable. Its recommendations for the filtration and applications of the main sites in the production process of large and small volume injections are as follows:

 

Station Membrane Solutions Recommended Filter Cartridge Series
①Decarbonization Filtration CRS Series Metal Sintering Filter Cartridge
CRST Series Metal Titanium Rod Filter Cartridge
②Prefiltration (Remove Particles) NMO Series Nylon Monofilament Filter Bag
Needle Felt Filter Bag(PP/PE/PTFE Series)
MicroPure Classic Series PP Melt Blown Filter Cartridge
PolyPure-Classic Series(PPC Series)PP Pleated Filter Cartridge with High Flux and High Flow Rate
MS 600 FlowPure-HF Pleated Filter Cartridge with High Flow
③Prefiltration (Reduce Biological Load) SteriPure Series(SP Series) PES Pleated Filter Cartridge with High Flow Rate and Long Service Life
SteriPure-B Series(SPB Series) Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency
PolymidPure Series(PN Series) Nylon66 Pleated Filter Cartridge with High Strength and High Temperature Resistance
KynarPure-L Series(PVL Series) Hydrophilic PVDF Pleated Filter Cartridge with Broad Chemical Compatibility
MedCap-UTC PES Series  PES Capsule Filter with High Flow Rate and Long Service Life
④Redundancy filtration SteriPure-B Series(SPB Series) Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency
SteriPure-P Series(SPP Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Long Service Life and High Efficiency
SteriPure-D Series(SPD Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency
PolymidPure Series(PN Series) Nylon66 Pleated Filter Cartridge with High Strength and High Temperature Resistance
KynarPure-L Series(PVL Series) Hydrophilic PVDF Pleated Filter Cartridge with Broad Chemical Compatibility
MedCap-UTC PESB Series PES Sterile-grade Capsule Filter with Low Protein Binding and High Retention Efficiency
⑤Terminal sterilization filtration SteriPure-B Series(SPB Series) Sterile-grade PES Pleated Filter Cartridge with High Flow Rate and High Efficiency
SteriPure-P Series(SPP Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Long Service Life and High Efficiency
SteriPure-D Series(SPD Series) Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency
PolymidPure Series(PN Series) Nylon66 Pleated Filter Cartridge with High Strength and High Temperature Resistance
KynarPure-L Series(PVL Series) Hydrophilic PVDF Pleated Filter Cartridge with Broad Chemical Compatibility
MedCap-UTC PESB Series PES Sterile-grade Capsule Filter with Low Protein Binding and High Retention Efficiency
⑥Respirator FluorPure-BG Series(FBG Series) Cost-effective PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements
FluorPure-SG Series(FSG Series) PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements
FluorPure-DG Series(FDG Series) Double-layer PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements
MedCap-UTC PTFESG Series PTFE Sterile-grade Capsule Filter with High Retention Efficiency and High Flux

For detailed technical solutions and product series information, please contact your MS sales engineer.

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