PW TANK

The PW tank is manufactured in accordance with ASME BPE standards. The products can be designed according to client’s requirements in the form of atmospheric pressure vessels or pressurized vessels. The part in contact with PW is made of 316L, and other parts (including frames) are made of 304 stainless steel. The tank is wrapped with insulation layer, which is made of the insulation material free of asbestos and chlorine. The insulation layer in turn is covered with 304 stainless steel shell. The inner wall of the tank is electro-polished, and the outer wall is hairline finished. The interface on the side wall of the tank is N/A connection to avoid dead legs. The tank is fully equipped with accessories, such as manhole, vent filter, spray ball, diaphragm pressure gauge (pressure transmitter), temperature sensor, level sensor and bursting disc.

Following accessories, instruments and valves considered.

  • Manway for access
  • AISI 304 stainless steel support legs
  • Sight glass with lamp
  • Rupture disc or sanitary safety valve.
  • Sanitary valve for purified water feeding
  • Automatic sanitary valve for tank discharge
  • Temperature probe with Thermowell
  • Level sensor
  • Spray ball
  • Absolute vent filter with electrically heating, and provision for integrity test

PW SKID

The PW storage and distribution SKID features professional modular 3D design, which is characterized with reasonable and compact structure, pleasant appearance, convenient daily maintenance and operator-friendliness. It can be customized according to user’s requirements. Based on the client’s requirements, the system can be designed with multiple sterilization modes, such as hot water sterilization, ozone sterilization, pure steam sterilization or 121℃ superheated water sterilization. The pumps, heat exchangers, valves, pipes, instruments and other main components selected for the equipment are all well-known brands around the world, which can ensure the stable operation of the system in a long term. The program is optimized in accordance with GAMP5, which improves the stability of the program and complete documentation system to ensure the traceability of the system. To check whether the PW system can stably produce PW that meets the quality requirements in various circumstances in the future, the system will be subjected to the main verification and testing activities including risk assessment (RA)/Design Qualification (DQ)/Installation Qualification (IQ)/Operation Qualification (OQ). The system can fully meet the requirements of FDA cGMP, EU GMP, WHO GMP and SFDA GMP.

WFI TANK

The WFI tank is manufactured in accordance with ASME BPE standards. The products can be designed according to client’s requirements in the form of atmospheric pressure vessels or pressurized vessels. The part in contact with WFI is made of 316L, and other parts (including frames) are made of 304 stainless steel. The tank is wrapped with insulation layer, which is made of the insulation material free of asbestos and chlorine. The insulation layer in turn is covered with 304 stainless steel shell. The inner wall of the tank is electro-polished, and the outer wall is hairline finished. The interface on the side wall of the tank is N/A connection to avoid dead legs. The tank is fully equipped with accessories, such as manhole, vent filter, spray ball, diaphragm pressure gauge (pressure transmitter), temperature sensor, level sensor and bursting disc.

Following accessories, instruments and valves considered.

  • Manway for access
  • AISI 304 stainless steel support legs
  • Sight glass with lamp
  • Rupture disc or sanitary safety valve.
  • Sanitary valve for WFI water feeding
  • Automatic sanitary valve for tank discharge
  • Temperature probe with Thermowell
  • Level sensor
  • Pressure transmitter or Pressure gauge
  • Spray ball
  • Absolute vent filter with electrically heating, and provision for integrity test

WFI SKID

The WFI storage and distribution SKID features professional modular 3D design, which is characterized with reasonable and compact structure, pleasant appearance, convenient daily maintenance and operator-friendliness. According to the actual requirements of clients and the operation mode of different dosage forms, the system can be designed for various operation modes, such as high temperature storage and high temperature circulation, high temperature storage and low temperature circulation, low temperature storage and low temperature circulation, with the purpose to conserve energy and reduce emissions. The system can be designed with multiple sterilization modes, such as pure steam sterilization or 121℃ superheated water sterilization. The pumps, heat exchangers, valves, pipes, instruments and other main components selected for the equipment are all well-known brands around the world, which can ensure the stable operation of the system in a long term. The program is optimized in accordance with GAMP5, which improves the stability of the program and complete documentation system to ensure the traceability of the system. To check whether the WFI system can stably produce WFI that meets the quality requirements in various circumstances in the future, the system will be subjected to the main verification and testing activities including risk assessment (RA)/Design Qualification (DQ)/Installation Qualification (IQ)/Operation Qualification (OQ). The system can fully meet the requirements of FDA cGMP, EU GMP, WHO GMP and SFDA GMP.

POU Piping

H+E Pharma can provide on-site piping network installation engineering for various clean utilities projects, such as PW and WFI.

PW and WFI are conveyed from the pharmacopoeia-compliant pharmaceutical water source to the point of use through the distribution pipeline. During the installation of the system, the slope of the pipeline and the quality of welding are in line with requirements, to ensure that there is no dead legs and the whole pipe network is drainable. According to client’s requirements, the POU valve can be elbow +T type diaphragm valve free of dead legs, U-bend + I-body valve, U-bend + common two-way diaphragm valve; cold POU with hot loop can be cooled by heat exchanger in the sub loop, tube-in-tube type, or heat exchanger cooling after POU according to different point properties.

The whole PW piping network can be sterilized with hot water, ozone, pure steam or superheated water at 121℃. The whole WFI piping network can be sanitized with pure steam or superheated water at 121℃.