Public System

Stable public system provides a strong support for the continuous production of enterprises. The water, gas and steam used in the production need to meet the cleanliness requirements of pharmaceutical process, GMP and the corresponding guidelines and regulations, and they play a key role in ensuring product quality and requirements of sanitary grade product. The pharmaceutical industry water systems in the bio-pharmaceutical industry are all required to undergo special treatment, mainly including purified water, water for injection, sterile water for injection, etc.; In order to ensure the cleanliness of the workshop and no pollution in the process of cell tissue culture, it is also necessary to sterilize and filter the gas, mainly including sterile compressed air, sterile nitrogen and other gas supply systems, as well as sanitary grade steam configuration system.

Pharmaceutical water: (1)Purified water: raw water prepared by distillation, ion exchange, reverse osmosis or other suitable methods for pharmaceutical use, without any additives. It can be used as the solvent or test water for preparing ordinary pharmaceutical preparations, and shall not be used for the preparation of injections. (2)Water for injection: water produced by distillation of purified water, also known as pyrogen-water. It is the solvent for the preparation of injections. (3)Sterile water for injection: water produced by sterilization of water for injection, it is sterile and pyrogen-free water. It is mainly used as the solvent for sterile powder for injection or as the diluent for injection solution. Its main filtering points are:

1. Pretreatment: remove large particles and impurities in water
2. Security filtration: pre-filtration before reverse osmosis to protect RO membrane
3. Sterile filtration: remove bacteria and microorganisms in water to stabilize water quality
4. Steam fine filtration: remove steam particles and pipe rust and impurities, protect the sterilization filter
5. Respirator: balance tank pressure, prevent pollution

 

The flow diagram of pharmaceutical water is roughly 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. Its recommendations for the filtration and applications of the main sites in the production process of pharmaceutical water are as follows:

 

Station	Membrane Solutions Recommended Filter Cartridge Series
①Pretreatment	NMO Series Nylon Monofilament Filter Bag
	Needled Felt Filter Bag (PP/PE/PTFE Series)
	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
②Security Filtration	MS 600 FlowPure-HF Pleated Filter Cartridge with High Flow
	MicroPure Classic Series PP Melt Blown Filter Cartridge
	PolyPure-Classic Series（PPC Series）PP Pleated Filter Cartridge with High Flux and High Flow Rate
③Respirator	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
④Terminal 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
⑤Steam Fine Filtration	CRPM Series Metal Pleated Filter Cartridge
	CRS Series Metal Sintering Filter Cartridge
	CRST Series Metal Titanium Rod Filter Cartridge

 

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

Sterile gas: The biological fermentation process, enzymatic catalysis process and cell tissue culture process of bio-pharmaceutical require sterile and impurity-free air, or purified nitrogen, or purified carbon oxide and other inert gases or nutrient gases. Untreated air contains water mist, oil mist, rust, dust particles, bacteria and many other impurities, which must be removed to ensure production safety and meet the requirements of gas use. Membrane Solutions provides users with complete solutions and the best cost-effective products for sterile air systems. The main filtration points for sterile gas are:
1. Gas sterilization prefiltration: remove some impurities and bacteria in the gas and protect the downstream sterilization filtration
2. Gas sterilization filtration: compressed air or other protective gas remove droplets, particles and bacteria
3. Steam fine filtration: remove steam particles and pipe rust and impurities, protect the sterilization filter

 

The flow diagram of sterile gas is roughly as follows:

 

 

Membrane Solutions’s recommendations for the filtration and applications of the main sites in the production process of sterile gas are as follows:

 

Station	Membrane Solutions Recommended Filter Cartridge Series
①Gas Sterilization Prefiltration	ProtecPure GlassFiber Pleated Filter Cartridge Glass Fiber Pleated Filter Cartridge with High Retention Efficiency and High Dirt Holding Capacity
	FluorPure-G Series（FG Series） Hydrophobic PTFE Pleated Filter Cartridge with Extremely Strong Chemical Compatibility
②Gas Sterilization Filtration	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
③Steam Fine Filtration	CRPM Series Metal Pleated Filter Cartridge
	CRS Series Metal sintering Filter Cartridge
	CRST Series Metal Titanium Rod Filter Cartridge

 

For detailed technical solutions and product series information, please contact your MS sales engineer.
Steam: The boiler inlet water is micro-filtered tap water, which is filtered to obtain sanitary grade steam for general system sterilization and CIP cleaning, and for heat exchange of coarse filtration steam system. Clean steam is an important guarantee for sterilization of the back pipe and filter. Its main filtration points are:
1. Steam prefiltration: separation of impurities such as steam droplets and rust
2. Steam fine filtration: remove steam particles and pipe rust and impurities, protect the sterilization filter

The flow diagram is roughly as follows:

 

 

Membrane Solutions recommendations for the filtration and applications of the main sites in the production process of sanitary grade steam filtration are as follows:

 

Station	Membrane Solutions Recommended Filter Cartridge Series
①Steam Prefiltration	CRPM Series Metal Pleated Filter Cartridge
	CRS Series Metal sintering Filter Cartridge
	CRST Series Metal Titanium Rod Filter Cartridge
②Steam Fine Filtration	CRPM Series Metal Pleated Filter Cartridge
	CRS Series Metal sintering Filter Cartridge
	CRST Series Metal Titanium Rod Filter Cartridge

 

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