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- Sterilization equipment
- Aseptic testing isolator
- Laboratory research and development of freeze-drying machine
- Laboratory freeze dryer
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- Imported small freeze-drying machine
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- Secondary Biosafety Cabinet
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Xingdeke Taishida Pharmaceutical Technology (Shanghai) Co., Ltd
Ethylene oxide sterilization cabinet
NegotiableUpdate on 02/03
- Model
- Nature of the Manufacturer
- Producers
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- Place of Origin
Overview
Ethylene oxide is a highly effective fungicide. It is a fungicide, sporicidal agent, and antiviral agent. It has a very favorable diffusion coefficient and can be used for thermosensitive or very fragile materials. Ethylene oxide sterilization cabinet
Product Details
Quality Choice
Since 1992, Taishida has delivered industrial scale EtO (ethylene oxide) sterilization units that have passed ATEX certification and have complete documentation of appropriate factory acceptance testing, installation/operation confirmation, and all other necessary requirements. Taishida can provide a wide range of solutions and services; From circular development to automatic loading and unloading systems, parameter release, EtO monitoring systems, pretreatment rooms, degassing/aeration rooms, as well as complete installation, commissioning, and confirmation of systems, auxiliary equipment, and even public facilities.
Taishida's professional knowledge and experience have been challenged by the high difficulty requirements of clients in developing multiple turnkey projects worldwide. The engineering and manufacturing practices of EtO devices follow ISO9001 procedures as well as EN1422, ISO11135:2014, ATEX2014/34/UE, FDA21CFR, and GAMP guidelines. The design and construction related to safety and pressure vessels comply with strict regulations and standards in Europe, the United States, and other regions.
Whether the business is equipment manufacturing or contract sterilization (CMO), the design of Taishida certification can be adjusted according to ATEX classification, modular design and structure, and can be adjusted at any time according to requirements.
Safety is of paramount importance
Taishida regards safety as a top priority and will always comply with current ATEX regulations. The ATEX regulations apply to facilities in any potentially explosive environment in Europe. In the United States, the corresponding regulation is called NEC500.
Three different types of studies were conducted for each project: risk level, risk analysis (HAZOP), and failure mode and effects analysis (FMEA), enabling TaiShiDa to obtain ATEX certification (09ATEX0001X) from the notified body INERIS (France).
Integrated a safety PLC for managing the control of the entire device in accordance with SIL (IEC61508) classification requirements.
Taishida's loop software programming can recognize the flammability map of EtO mixtures, avoiding the execution of formulas with parameters that may cause explosive mixtures.
Pre treatment and degassing/aeration chamber
The use of degassing and pretreatment chambers can significantly reduce the EtO cycle time. Taishida provides customers with the opportunity to install this configuration, which utilizes high air circulation and removal technology to shorten processing time.
EtO emission reduction or air purification system
There are usually two techniques used for EtO treatment after use in the sterilization chamber:
The washer system uses water and sulfuric acid to convert EtO into ethylene glycol.
The catalytic system is more efficient and independent due to the conversion of EtO to CO2. As national and international regulations become increasingly stringent on the emission of ethylene oxide and residues into the atmosphere, Taishida recommends adopting a complete LESNITM catalytic emission reduction solution. The Abator catalytic system uses validated catalytic oxidation technology to provide safe and controllable purification, with high efficiency in destroying various gases emitted during the sterilization process.
Automatic pallet loading and unloading system
The advantage of obtaining this optional accessory is that it greatly shortens the loading/unloading operation time and improves the operator's ergonomics/safety.
Release of parameters for ethylene oxide sterilization cabinet
Taishida can also provide a special ATEX certified EtO infrared detector, which is connected to the recirculation pipeline and displays the chamber ETO concentration value in real time.
Parameter release allows products to be released to the market based solely on process records rather than traditional biological indicator sterility testing. This is beneficial in eliminating the conventional costs associated with biological indicators and laboratory testing.
Ethylene oxide sterilization cabinet control system
The device is equipped with a complete SCADA control system Pharmaster ®。
Pharmaster ® Integrated with the entire sterilization equipment located in non classified areas (including all the modules or systems mentioned above).
The system includes an industrial computer with an optional touch screen color display. This software not only monitors the entire process, but also compiles, stores, and processes the entire information in batch oriented mode. This system complies with the guidelines of 21CFR Part 11.
The operations that pose potential risks are controlled through an integrated PLC module, which is SIL certified, tamper proof, and has restricted access.
Since 1992, Taishida has delivered industrial scale EtO (ethylene oxide) sterilization units that have passed ATEX certification and have complete documentation of appropriate factory acceptance testing, installation/operation confirmation, and all other necessary requirements. Taishida can provide a wide range of solutions and services; From circular development to automatic loading and unloading systems, parameter release, EtO monitoring systems, pretreatment rooms, degassing/aeration rooms, as well as complete installation, commissioning, and confirmation of systems, auxiliary equipment, and even public facilities.
Taishida's professional knowledge and experience have been challenged by the high difficulty requirements of clients in developing multiple turnkey projects worldwide. The engineering and manufacturing practices of EtO devices follow ISO9001 procedures as well as EN1422, ISO11135:2014, ATEX2014/34/UE, FDA21CFR, and GAMP guidelines. The design and construction related to safety and pressure vessels comply with strict regulations and standards in Europe, the United States, and other regions.
Whether the business is equipment manufacturing or contract sterilization (CMO), the design of Taishida certification can be adjusted according to ATEX classification, modular design and structure, and can be adjusted at any time according to requirements.
Safety is of paramount importance
Taishida regards safety as a top priority and will always comply with current ATEX regulations. The ATEX regulations apply to facilities in any potentially explosive environment in Europe. In the United States, the corresponding regulation is called NEC500.
Three different types of studies were conducted for each project: risk level, risk analysis (HAZOP), and failure mode and effects analysis (FMEA), enabling TaiShiDa to obtain ATEX certification (09ATEX0001X) from the notified body INERIS (France).
Integrated a safety PLC for managing the control of the entire device in accordance with SIL (IEC61508) classification requirements.
Taishida's loop software programming can recognize the flammability map of EtO mixtures, avoiding the execution of formulas with parameters that may cause explosive mixtures.
Pre treatment and degassing/aeration chamber
The use of degassing and pretreatment chambers can significantly reduce the EtO cycle time. Taishida provides customers with the opportunity to install this configuration, which utilizes high air circulation and removal technology to shorten processing time.
EtO emission reduction or air purification system
There are usually two techniques used for EtO treatment after use in the sterilization chamber:
The washer system uses water and sulfuric acid to convert EtO into ethylene glycol.
The catalytic system is more efficient and independent due to the conversion of EtO to CO2. As national and international regulations become increasingly stringent on the emission of ethylene oxide and residues into the atmosphere, Taishida recommends adopting a complete LESNITM catalytic emission reduction solution. The Abator catalytic system uses validated catalytic oxidation technology to provide safe and controllable purification, with high efficiency in destroying various gases emitted during the sterilization process.
Automatic pallet loading and unloading system
The advantage of obtaining this optional accessory is that it greatly shortens the loading/unloading operation time and improves the operator's ergonomics/safety.
Release of parameters for ethylene oxide sterilization cabinet
Taishida can also provide a special ATEX certified EtO infrared detector, which is connected to the recirculation pipeline and displays the chamber ETO concentration value in real time.
Parameter release allows products to be released to the market based solely on process records rather than traditional biological indicator sterility testing. This is beneficial in eliminating the conventional costs associated with biological indicators and laboratory testing.
Ethylene oxide sterilization cabinet control system
The device is equipped with a complete SCADA control system Pharmaster ®。
Pharmaster ® Integrated with the entire sterilization equipment located in non classified areas (including all the modules or systems mentioned above).
The system includes an industrial computer with an optional touch screen color display. This software not only monitors the entire process, but also compiles, stores, and processes the entire information in batch oriented mode. This system complies with the guidelines of 21CFR Part 11.
The operations that pose potential risks are controlled through an integrated PLC module, which is SIL certified, tamper proof, and has restricted access.
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