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Active Pharmaceutical Ingredients Biotechnology

Active Pharmaceutical Ingredients refer to the raw materials used in the production of various preparations. They are active ingredients in the preparations, and they are a variety of powders, crystals and extracts prepared by chemical synthesis, plant extraction or biotechnology that are used as medicinal substances, but cannot be directly taken by patients. According to the demand for pharmaceutical preparations, the production of APIs can be divided into two types: sterile API production and non-sterile API production.


Sterile APIs do not contain any active microorganisms ,such as molds, bacteria, viruses, etc., and are upstream products of pharmaceutical preparations. Compared with non-sterile APIs, the production of sterile APIs not only needs to pay attention to the requirements of chemical quality indexes such as product impurities and physical and chemical properties, but also needs to pay attention to the sterility assurance of products from the beginning of process design. Therefore, the production of sterile APIs has higher requirements on environment and equipment. At present, the most commonly used method in production is sterile filtration method, that is, the non-sterile intermediates or raw materials are formulated into solutions, and then passed through a 0.2μm pore size filter to remove bacteria. It is then kept sterile through a series of unit operations used for refining, and finally the APIs that meet the sterility requirements are produced.

 

Take antibiotic APIs as an example:
Antibiotics refer to a class of secondary metabolites with anti-pathogen or other activities produced by microorganisms (including bacteria, fungi, actinomycetes) or higher animals and plants in the course of their lives, and refer to chemicals that can interfere with the developmental functions of other living cells. Antibiotics commonly used in clinical practice include extracts from microbial culture fluids and chemically synthesized or semi-synthetic compounds. Antibiotic APIs, such as penicillins, cephalosporins, etc., are usually obtained by fermentation and semi-synthetic of chemical synthesis.


Filtration is widely used in different process stages of antibiotic APIs, mainly including ultra-filtration concentration, decarbonization filtration, sterilization filtration of gas, prefiltration and filtration of terminal products, etc. The main filtration sites of the whole process are:
1. Security filtration: prefiltration before ultra-filtration to protect the ultra-filtration module
2. Decarbonization filtration: remove activated carbon particles to protect downstream filter element
3. Prefiltration: 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 is roughly as follows:

Sterile APIS

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 antibiotic APIs preparation process more cost-effective and reliable. Its production process, its main site filtering and application recommendations are as follows:

 

Station Membrane Solutions Recommended Filter Cartridge Series
①Security Filtration NMO Series Nylon Monofilament Filter Bag
Needled 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
②Decarbonization Filtration CRS Series Metal sintering Filter Cartridge
CRST Series Metal Titanium Rod Filter Cartridge
③Prefiltration 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, please contact your MS sales engineer.

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