Ethylene-Oxide Sterilization Services CENTERPIECE STERILIZATION FEATURES 100% EO Sterilization Located in Tijuana, Mexico 10 Miles from the US Border CTPAT Partner DID YOU KNOW? Sterilization Services - Leading provider of solutions in sterilization supply chain management; Providing sterilization services to medical device industry; Medical Device Sterilzation, ethylene oxide; medical device; eto, drug device sterilsation. Address:Xiangjiang Road,Industry Zone,Hua County Henan Province ,China, Telephone: +86 18317721166 +86-372-8192266 +86 18837238975 Email: support@cnhuataigroup.com. Higher density configurations may impact temperature distribution and processing time, Processing conditions exposes product to heat, humidity, and pressure, Gas must reach surfaces requiring sterilization, CHARACTERIZATION OF NORMAL PRODUCT BIOBURDEN, Understanding the microbiological challenge of the product relevant for defining a sterilization process, (depends on validation approach and time required for degassing). As part of our commitment to providing innovative and sustainable solutions, STERIS AST has developed the Sustainable EO® sterilization services program. _linkedin_data_partner_id = "278329"; Find out what makes our EO Sterilization process unique. info@rsd-engineering.com GMP’s specify that this type of sterilization should only be used when there is no alternative sterilization technology. Telstar can offer a broad range of solutions and services; from cycle development to automatic loading/unloading systems, parametrical release, EtO monitoring system, preconditioning chambers, degassing/aeration chambers and complete installation, commissioning and qualification of system, ancillary equipment and even utility services. The data may be transferred to other companies of the Azbil Telstar group, with the intent to exercise their rights of access and rectification in accordance with the. The program includes innovative approaches to EO sterilization, such as cycle design, validation strategy, and process challenge device design, all focused on the reduction of EO residuals on healthcare products. A full report and very well detailed at the end of each sterilization cycle. The EO TechTeam provides technical support for all matters relating to ethylene oxide, including (but not limited to): Technical consultation, process development/optimization, sterilization validation, technical resources, and general research and development. var b = document.createElement("script"); Sustainable EO ® Sterilization Services; Vaporized Hydrogen Peroxide; Testing & Validation. Contract EO Sterilization Services Contract sterilization services. As part of our commitment to providing innovative and sustainable solutions, STERIS AST has developed the Sustainable EO sterilization services program. Our Sustainable EO services provide Customers with strategies to reduce the EO sterilant used in the sterilization process to achieve the prescribed Sterility Assurance Level. Telstar can also provide a unique ATEX certified EtO IR detector, which is connected to the recirculation pipe and indicates the value of the chamber EtO concentration in real time. The complex design of these types of medical devices makes the penetrability of the sterilizing agent one of the most critical aspects. Ethylene Oxide Sterilization (EtO) Sterilization using EtO is just as effective as gamma irradiation at providing a sterility assurance level of 10-6. If you have any questions, please contact us! Ethylene Oxide (EO or ETO) is among the most common sterilization methods in the medical device industry. In addition, it ensures there is no DNA that can be amplified to a level where there is risk of subsequent interference. b.type = "text/javascript";b.async = true; It is a bactericide, a sporicide and a viricide. Sustainable EO ® Sterilization Services Sustainable EO ® Sterilization Ethylene oxide (EO) is a universally accepted sterilization technology that has delivered safe, sterile healthcare products for patient care since the 1960s. In addition to ethylene oxide sterilization, STERIS AST provides our Customers with laboratory testing and technical support at every stage of the sterilization design process, from cycle development through routine processing. This is advantageous in that it eliminates the routine costs associated with biological indicators and laboratory testing. ATLANTA — Another metro Atlanta company has been accused of - and fined for - spewing the cancer-causing gas ethylene oxide into the air. Date：2020-07-02 15:33. Our Sustainable EO services provide Customers with strategies to reduce the EO sterilant used in the sterilization process to achieve the prescribed sterility assurance level. A safety PLC is integrated for managing control of the entire installation in accordance to regulations required to comply with the SIL (IEC 61508) classification. The treatment of EtO after its use in the sterilization chambers is typically carried out with two types of technologies: The advantages of acquiring this option are a significant time reduction for loading/unloading operations and operator ergonomics/safety. However, with the use of ethylene oxide as a sterilant, human safety and environmental challenges must be considered. A study was carried out to compare the impact, if any, of EO concentration on product EO residual levels determined in accordance with ISO10993-7. Generally sterilization with ethylene oxide in the pharmaceutical industry has been restricted given the risk it entails due to its high mutagenic and carcinogenic properties. The use of degassing and pre-conditioning chambers can significantly reduce the EtO cycle time. Ethylene oxide sterilization device is the key equipment of a single-use sterile medical device manufacturing enterprise. The scorecard, which can also be provided as a benchmark for existing sterilization cycles, highlights the achieved sustainability rating by showing the EO concentration (mg/l) used in each cycle. PRO-TECH runs mixed loads with product adopted into our iPCD-based product family, allowing our customers to pay a fraction of the sterilization cost. RSD® proposes an advanced treatment for Ethylene Oxide sterilization (EO) for your pharmaceutical or medical products.We offer subcontracting services using Ethylene Oxide (EO/ETO) method. Mechanical aeration for 8 to 12 hours at 50 to 60°C allows desorption of the toxic ETO residual contained in exposed absorbent materials. 3. Telstar regards safety as a major priority and will always conform to the current ATEX regulations. The software allows not only for supervision and control of the process, but also compiling, storing and processing the whole information in a batch oriented mode. Let our team review your process and identify other ways to help reduce EO sterilant used through our Sustainable EO® sterilization services, ServiceElectron BeamEthylene OxideGammaTesting & ValidationVaporized Hydrogen Peroxide. C/Horts d'en Mateu nº26 – 08450 Llinars del vallès (Barcelona) - Spain A cycle validation service adapted to the product technical requirements, Ethylene Oxide sterilization routine cycles, (chamber sterilization + separate degassing cell). The leading companies in this sector still rely on ethylene oxide for the terminal sterilization of syringes, probes, catheters, pace makers, etc. Parametric release enables the product to be released to the market based on only process records instead of the traditional biological indicator sterility test. PharmaSter ® integrates the entire sterilization plant (comprised of all of the above modules or systems), located in a non-classified area. Steritec’s mission is to recognize and fulfill medical care needs through safe and efficacious sterilization processes. Sterilization Services, Inc. Founded in 1976 in response to the market's need for professional service in contract sterilization, Sterilization Services of Tennessee Inc. was opened. Telstar provides customers the opportunity to install such a configuration, with a technology using high air circulation and removal, resulting in shorter process times. We work with our clients to develop a customized process based on individual needs, ensuring a responsive, consistent and cost effective experience that gets your product to market without delay. Data on meeting these limits is established during the validation of the EO process. Three different types of studies are carried out on each project: Hierarchy of Risks, Risks Analysis (HAZOP) and Failure Mode and Effect Analysis (FMEA), which enables Telstar to obtain the official ATEX certification (09ATEX0001X) from the notified body INERIS (France).