
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:
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 |
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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.
Products About Preparations
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FluorPure-DG Series Double-layer PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements
FDG series PTFE pleated filter cartridge is made of double-layer sterile-grade PTFE membrane, which has higher retention efficiency and can meet the requirements of phage retention and other harsh conditions to provide extremely reliable sterility guarantee for gases.
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FluorPure-SG Series PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements
FSG series PTFE pleated filter cartridge is made of strong hydrophobic and uniformly distributed pore size PTFE membrane. Its proven sterilization ability and stable chemical properties enable the filter to provide excellent sterility protection for high humidity gas and low surface tension liquid even after 150 times of moist heat sterilization at 121℃.
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MicroPure Classic Series PP Melt Blown Filter Cartridge
PP melt blown filter cartridge is made of 100% pure PP particles without any adhesive, and is made by fiber hot-melt entanglement. The unique three-layer gradient pore size design forms a three-dimensional slag filtering effect, which has the characteristics of high porosity, high retention efficiency, high dirt holding capacity and low pressure difference. The pure PP structure makes it have extensive chemical compatibility and is suitable for the filtration of strong acid, strong alkali and organic solvents. The advanced fiber hot-melt technology can meet the various needs of customers for this product.
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NMO Series Nylon Monofilament Filter Bag
Nylon monofilament filter bag is made of filter material woven by a single nylon fiber, and the structure is welded and fused or wire stitched. It has good compressive strength, smooth surface and is not easy to deform, easy to clean and can be used repeatedly. It is suitable for the fields with low removal rating requirements such as coarse filtration or prefiltration as well as liquid filtration with high impurity content.
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SteriPure-D Series Sterile-grade Double-layer PES Pleated Filter Cartridge with Higher Removal Efficiency
SPD series PES pleated filter cartridge is made of double-layer imported asymmetric PES membrane. The double-layer sterile-grade membrane provides a higher level of sterilization protection. It is suitable for harsh sterile terminal filtration.
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PolyPure-Classic Series PP Pleated Filter Cartridge with High Flux and High Flow Rate
PPC series PP pleated filter cartridge is made of high fluffy polypropylene filter material, which has the characteristics of high flow rate and high dirt holding capacity. It has excellent cost performance as clarification filter and pre-filter. The full PP structure enables the filter cartridge to be applied to the filtration of various acid and alkali and organic solvents.
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PolymidPure Series Nylon66 Pleated Filter Cartridge with High Strength and High Temperature Resistance
PolymidPure Nylon 6,6 membrane pleated filter cartridge uses a controlled porosity and naturally hydrophilic Nylon 6,6 membrane, which contains any wetting agents, has excellent chemical compatibility and mechanical strength. After special cleaning steps, the filter membrane has low precipitation and no shedding. It can be widely used in the filtration of strong alkali, weak acid and organic solvents. High quality all-polypropylene components and high strength Nylon 6,6 membrane with polyester support layer have excellent heat and pressure resistance and meet the requirements of most applications. PolymidPure can provide a sterilizing-grade filter cartridge with double layer 0.2μm membrane. A validation guide for compliance with regulatory requirements is available.
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KynarPure-L Series Hydrophilic PVDF Pleated Filter Cartridge with Broad Chemical Compatibility
PVL series PVDF pleated filter cartridge is made of unlined hydrophilic PVDF membrane. The filter membrane has the characteristics of symmetrical pore type, uniform hydrophilicity, high porosity and extremely low protein binding, which make the filter cartridge is easy to use without pre-wetting. The filter cartridge is suitable for the sterilization filtration of various biological products.