Designing for Sterilisation: Materials and Product Design Considerations
Synergy Health, as a global supplier of sterilisation solutions to medical device manufacturers, offers a technology-neutral and bespoke approach to all members of the market. With over 30 years’ experience and a global network of technology and regulatory experts, Synergy Health is renowned for its service and quality leadership within the sterilization market.
In all locations, Synergy Health is proud of its record of exceeding environmental, ethical, and health and safety standards, which are essential in this highly regulated industry. The stringent controls and innovative quality systems incorporated in all processes ensure that all customers receive an exemplary service.
With a detailed understanding of all medical device sterilisation requirements, from design to regulatory compliance, Synergy Health offers support and guidance to a diverse range of medical device manufacturers. With an appreciation of the importance of sterilisation services to your business, Synergy Health endeavours to operate as an extension of your organisation, enabling you to offer a regulatory complaint and cost-effective product to the market.
Synergy Health employs the following sterilisation technologies:
Gamma irradiation sterilisation
A wide variety of healthcare products from implants to pharmaceuticals employ gamma for its sterilising capability. In the context of sterilisation it is generally accepted that these species induce breaks in the DNA double helix, preventing replication and hence sterilisation.
Electron beam irradiation sterilisation
As well as being a highly established method used for initiating change at a molecular level in polymers, electron beam irradiation has also established itself as an effective sterilization process for medical devices, dressings and pharmaceuticals.
X-ray irradiation sterilisation
Processing by X-ray radiation is another form of irradiation processing and is suitable for a range of healthcare products, from medical devices to pharmaceuticals. X-rays are produced by placing a metal (tantalum) target between the electron beam and the product to be treated. A key feature of this technology is its ability to mix different products with different dose requirements in the same irradiation cycle.
Ethylene oxide sterilisation
Ethylene oxide (EO) is a gas that is widely used for sterilisation in the healthcare industry. During the sterilization phase, products are exposed to the EO gas which kills the organisms by reacting with its cellular constituents.
Microbiological laboratories for medical device testing
In addition to its technologies, Synergy Health operations are fully supported by microbiology laboratories. With its markets primarily in medical devices and related industries, these Synergy Health facilities are able to provide a range of regulatory complaint tests such as microbiological validations and determination of contamination levels. It is not just medical device customers that can benefit from Synergy Health’s laboratory services; the range of tests, training and consultation provided can assist a variety of customers whatever the industry.
Regulatory compliance in medical device sterilisation
In order to satisfy your customers’ requirements you need to work with a partner that can offer and deliver a reliable and comprehensive service. Synergy Health prides itself on its continued commitment to technical excellence by investment in its employees and active participation in ISO CEN committee working groups to ensure compliance to all the applicable regulatory standards is guaranteed.
Quality and regulatory affairs consultancy
Synergy Health has entered in to collaboration with High Edge Consultancy to provide additional support to our customer base. This collaboration creates invaluable links between Synergy Health and High Edge Consulting, which will benefit both companies’ clients. By working together, the manufacturers of medical devices can now have expert advice on both sterilisation technologies and on compliance to the relevant directives and standards.
Synergy Health – specialist outsourced services for healthcare providers
Synergy Health delivers a range of specialist outsourced services to healthcare providers and other customers requiring health management, and operates six core divisions globally:
- Applied Sterilisation Technologies for single-use medical devices and other products
- Hospital Sterilisation Services for reusable medical and surgical equipment
- Healthcare Solutions to manage the patient’s environment, specialising in infection control, wound care and surgical products and services
- Linen Management services for healthcare facilities
- Laboratory Services including clinical pathology, toxicology and microbiological services, together with occupational health programmes
- Pharmaceutical Laboratories for a comprehensive range of pharmaceutical testing services
Synergy Health will attend a sterilisation seminar on 9 June in Stuttgart, Germany.
Synergy Health will be exhibiting at the Florida Medical Device Symposium at the Hilton Carillon Park Hotel on May 6th - 7th, 2013. We look forward to welcoming you.
Synergy Health, leading global supplier of outsourced sterilisation services is to host an education day to discuss the requirements of designing healthcare products for sterilisation.
Synergy Health is pleased to announce expansion at the Ethylene Oxide Thorne facility, located near Doncaster, UK. As a leading global service provider, Synergy Health is committed to expanding its portfolio of locations and technologies to support customer requirements.
Synergy Health Applied Sterilisation Technologies (AST) to Exhibit at Med-Tech Innovations Conference 2012
Synergy Health will be exhibiting at the 2012 Med-Tech Innovation conference and exhibition (stand number 1). Held at Brunel University, London, Synergy Health will be showcasing its portfolio of technologies and assisting delegates with their sterilisation requirements
Synergy Health will be the first sterilisation service provider to open an ethylene oxide (EO) facility in Central America.
Synergy Health will be holding an EO validation workshop on 5 September. Open to potential and existing customers, the EO workshop will provide an overview of the technology as well as an in-depth review of the validation methodology.
Synergy Health is hosting an irradiation validation workshop on 6 September, giving attendees a background on technologies and compliance with an in-depth session on validation methods.
Synergy Health will be the first sterilisation service provider to open an ethylene oxide (EO) facility in central America.
Synergy Health has announced its 2012 education day schedule. The first event, 'Designing for Sterilization', will take place on 26 January in Solihull.
Synergy Health - Applied Sterilisation Technologies (formerly Isotron) is now offering packaging integrity testing to support medical device manufacturers
Isotron (Applied Sterilisation Technologies, Synergy Health plc) will be presenting at a conference and workshop in association with DuPont, Amcor Flexibles, Multivac and Anecto on 'Risk Management: The Correct Approach for Packaging and Sterilisation of Medical Devices'. The aim of th
Isotron, the sterilisation services division of Synergy Health, will be celebrating the tenth birthday of its e-beam at the Daventry site in July 2011. The site, based in Northamptonshire, UK, is home to both gamma and electron beam and is proud to still employ nine of the original staff.
Isotron Thailand has won an award for safety and environmental operations within the radiation industry. The award was issued by the Thai office of Atoms for Peace (OAP) during its 50th anniversary. Isotron Thailand was the only contract irradiator who achieved the award, which was presented by
Isotron, the sterilisation specialist, is to present at the fourth annual Informa Sterilisation Conference. As the Sterilisation Services division of Synergy Health, Isotron employs a number of technical experts who have an exemplary understanding of the sterilisation technologies and associated
Isotron, the irradiation specialist, is one of the sponsors of the 16th global forum of IMRP (international meeting on radiation processing), which will be held in Montreal from 13-16 June 2011. Representatives from Isotron will be presenting the following subjects: Qua
Isotron, Europe's leading sterilisation specialist, is pleased to announce that a revised version of the Designing for Sterilisation white paper is now available. This document provides the industry with an insight into the principal sterilisation methodologies. The white paper is part
Isotron is to host its next education day on the topic of Good Cleanroom Practice and Environmental Monitoring on 17 May 2011. The day, which will take in Stratford-upon-Avon, will provide an overview of basic Good Manufacturing Practice (GMP) principals, clarification on regulations as well as c
Isotron, Europe's leading supplier of sterilisation services, is to host an EtO education day on 2 March 2011. The day, which will take place in Stratford-upon-Avon, will provide an introduction to theory and technology as well as a practical insight into the validation process and the applicatio
Isotron (the sterilisation division of Synergy Health) has acquired German sterilisation company Gamma Service Produktbestrahlung (GSP). GSP currently operates gamma and electron beam technologies in Dresden, Eastern Germany. The acquisition of GSP will extend the portfolio of locations and techn
Ensuring regulatory compliance when CE marking a device as sterile requires a good level of technical knowledge and the involvement of your manufacturing and QA / RA departments, as well as your sterilisation provider. As Europe's leading supplier of outsourced sterilisation services,